Know Labs, Inc. Announces $300K Registered Direct Offering




Know Labs, Inc. Announces $300K Registered Direct Offering

SEATTLE–(BUSINESS WIRE)–Know Labs, Inc. (NYSE American: KNW) (the “Company”), a leading developer of non-invasive medical diagnostic technology, today announced the pricing of a registered direct offering with gross proceeds to the company of  $300K before deducting placement agent fees and other estimated expenses payable by the Company.

This was a unit offering comprised of one share of stock and one warrant. The purchase price of the unit was $0.24 a share and the warrant is exercisable at $0.24. The warrants will expire on the fifth anniversary of the warrant issuance. The warrants also have a cashless exercise option in certain circumstances. This was a registered direct offering priced at-the-market under NYSE American rules.

The offer and sale of the units is being made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-276246) (the “Registration Statement”) filed with the U.S. Securities and Exchange Commission (“SEC”) on December 22, 2023 and declared effective by the SEC on January 11, 2024, as supplemented by a prospectus supplement dated December 13, 2024 and filed with the SEC pursuant to Rule 424(b) (the “Prospectus Supplement”) under the Securities Act of 1933, as amended (the “Securities Act”). The offering of the units is being made only by means of the Prospectus Supplement that forms a part of the effective Registration Statement. A final Prospectus Supplement and the accompanying base prospectus relating to the units being offered in the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the final Prospectus Supplement and the accompanying base prospectus may also be obtained, when available, from Know Labs, Inc. Attn: Secretary at 619 Western Avenue, Suite 610, Seattle, WA 98104, by phone at (206) 903-1351 or e-mail at pete@knowlabs.co.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Further information can be found in Know Labs, Inc.’s Form 8-K filing with the Securities and Exchange Commission expected on or about Monday, December 16, 2024.

For more information on Know Labs, visit www.knowlabs.co.

About Know Labs, Inc.

Know Labs, Inc. is a public company whose shares trade on the NYSE American Exchange under the stock symbol “KNW.” The Company’s platform technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The technology is designed to be able to integrate into a variety of wearable, mobile, bench-top or other form factors. The Company believes that this patented and patent-pending technology makes it possible to effectively identify and monitor analytes that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The Company’s technology is applicable to many diverse fields of use. The Company’s first expected application of the technology will be in a product marketed as a non-invasive glucose monitor. The device is designed to provide the user with accessible and affordable real-time information on blood glucose levels. This product will require U.S. Food and Drug Administration clearance prior to its introduction to the market.

Safe Harbor Statement

This release contains statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of Know Labs, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy; and (iv) performance of products. You can identify these statements by the use of the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” “potential,” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond Know Labs, Inc.’s ability to control, and actual results may differ materially from those projected in the forward-looking statements as a result of various factors. These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended September 30, 2024, Forms 10-Q and 8-K, and in other filings we make with the Securities and Exchange Commission from time to time. These documents are available on the SEC Filings section of the Investor Relations section of our website at www.knowlabs.co. The Company cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made.

Contacts

Know Labs, Inc. Contact:
Email: ask@knowlabs.co
Ph. (206) 903-1351

Walgreens Launches Inaugural Patient Advisory Board to Advance Access and Representation in Clinical Research




Walgreens Launches Inaugural Patient Advisory Board to Advance Access and Representation in Clinical Research

The Walgreens Patient Advisory Board will collaborate with the Walgreens Clinical Trials team to provide insights aimed at increasing representation in clinical trials.

DEERFIELD, Ill.–(BUSINESS WIRE)–With a history of more than 120 years serving communities across the country, Walgreens prides itself in being a trusted retail pharmacy partner for more than 9 million patients and customers it serves each day. Walgreens is amplifying its commitment to its patients and partners through the formation of the Walgreens Clinical Trials Patient Advisory Board. Since its launch in June 2022, the Walgreens Clinical Trials team has reached more than 7 million patients to potentially recruit into sponsor-led clinical trials. As the team continues expanding its scope and raising awareness about the importance of community-centered clinical research, the Patient Advisory Board members will offer key patient insights that are an invaluable resource to the delivery and advancement of clinical trials.

The inaugural Patient Advisory Board consists of 10 patient experts who will leverage both lived and learned experiences to inform clinical trial recruitment and retention efforts to increase access and representation in clinical research in communities that have historically been excluded. Ramita Tandon, chief biopharma services officer, is standing up the Board as part of Walgreens’ commitment to bringing community-based clinical research to more people that may benefit from it.

“I am proud to engage with our inaugural cohort of Patient Advisory Board members to increase awareness and representation in clinical trials. Only 5% of the U.S. population participates in clinical trials and nearly 80% of trials fail to meet their enrollment goals, often contributing to delays in bringing new medications to patients,” said Tandon. “Our Patient Advisory Board members will help inform how we approach our sponsor-led clinical trials to better serve our patients and partners.”

With increasing regulatory focus on incorporating patients’ perspectives in medical product development,^1,2 and the growth of precision medicine,³ now more than ever, it’s important to engage with patients and individuals who have had experience with clinical research as their lived experiences offer an opportunity to continue improving clinical trials to best serve patients.

Walgreens Clinical Trials Patient Advisory Board members will commit to serve a 2-year term and will offer ongoing counsel, diverse thinking and expertise to inform Walgreens Clinical Trials efforts.

Learn more about Walgreens Clinical Trials here. ​

About Walgreens ​

Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.​

Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.

1. Patient Engagement Collaborative. https://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-engagement-collaborative
2. Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data. December 13, 2024 https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-workshop-discuss-methodologic-and-other-challenges-related-patient
3. https://www.biospace.com/press-releases/precision-medicine-market-size-to-reach-usd-470-53-billion-by-2034

Contacts

Carmen Lopez

Walgreens Media Relations

media@walgreens.com

Biotech Nintx Raises US$ 10 Million to Advance a New Generation of Medicines Based on Brazilian Biodiversity




Biotech Nintx Raises US$ 10 Million to Advance a New Generation of Medicines Based on Brazilian Biodiversity

Startup funding includes a Series A round led by venture capital firms Pitanga, Ecoa Capital and MOV Investimentos, along with a grant from FINEP

SÃO PAULO–(BUSINESS WIRE)–Following a US$ 3 million seed investment in 2022, Nintx (Next Innovative Therapeutics), a biotech company researching and developing treatments for multifactorial diseases using Brazil’s biodiversity, has just raised an additional US$ 10 million.

The investments will support the company’s plans for the coming years, which include accelerating the R&D of eight new drug programs (mostly in partnership with companies, such as Adeste and Centroflora, and research institutions, such as CIEnP and CNPEM, which houses Sirius, one of the largest particle accelerators in the world), hiring researchers, introducing new technologies, and expanding the laboratory.

Nintx employs an innovative approach to tackling multifactorial diseases caused by genetic and environmental factors as well as their interactions, especially those mediated by the human gut microbiome. The biotech focuses on multi-target therapies, leveraging proprietary technologies such as xGIbiomics^®, which simulates the gastrointestinal system, and GAIApath^®, a knowledge-graph data analytics platform that maps connections between plants, natural products, biological targets, the human microbiome, and multifactorial diseases.

Nintx’s business model involves advancing therapies to the end of preclinical studies, at which point it plans to license them to large pharmaceutical companies for clinical development and commercialization. The team anticipates that the first drug candidate will be licensed within three years.

Investors in the Series A round include venture capital firms Pitanga, Ecoa Capital and MOV Investimentos. Strategic partners Tiaraju and Adeste also invested to strengthen synergies between their businesses and Nintx. Guilherme Leal, co-founder of Natura and Dengo, and Peter Andersen, from Centroflora, remain shareholders. The Series A funds — unprecedented for a biotech startup in Brazil’s pharmaceutical sector — are complemented with a grant of US$ 2.5 million by FINEP, a public company that promotes and finances science, technology and innovation.

“In the U.S. and Europe, biopharmaceutical startups that begin licensing innovative drugs to major pharma companies can achieve valuations in the hundreds of millions of dollars. We believe Nintx has the potential to follow the same trajectory,” says Gabriel Perez from Pitanga.

“What drew our attention was Nintx’s social and environmental impact potential, as it values biodiversity through agroforestry practices, investments in small farmers, and benefit-sharing agreements with communities that hold knowledge about these plants,” says Paulo Bellotti from MOV Investimentos.

New Leadership

The funding coincides with a leadership restructuring at Nintx. Stephani Saverio, who co-founded the company alongside scientists Miller Freitas and Cristiano Guimarães, assumes the role of CEO in January of 2025. Previously serving on the Board of Directors, Saverio now steps into an executive role.

With over 25 years of experience in major pharmaceutical groups, Saverio leaves the position of Global Vice President of Business Development at Knight Therapeutics, a pan-American specialty pharmaceutical company, to take on the challenge at Nintx.

“The new C-level structure, where Saverio becomes CEO, I assume the role of CDO (Chief Development Officer), and Cristiano remains CSO (Chief Scientific Officer), has been part of our strategic plan for this next phase of the startup,” says Freitas.

“Nintx is a rare case in Brazil as most companies in the country are focused on established technologies, resulting in a lack of global competitiveness. We are on track to establish a biotech company focused on truly innovative therapies—a pioneering approach in Brazil’s pharmaceutical industry,” Saverio adds.

About Nintx

Nintx develops a new generation of medicines leveraging biodiversity, primarily from Brazil. One of its key innovations is a broader approach to tackling multifactorial diseases, caused by genetic and environmental factors as well as their interactions via the human gut microbiome. Multifactorial diseases include metabolic, immunological, cancer, and brain disorders. Nintx develops therapies targeting biological pathways directly and indirectly through gut microbiome modulation—both closely linked to the onset or worsening of multifactorial diseases.

Contacts

Nintx Contact
E-mail – info@nintx.com.br
Phone – +55 11 99947-9278

Press Contact
Pecan Comunicação
Vinicius Claudio – +55 47 99641-1998 / vinicius@pecancom.com.br
Patricia Cançado – +55 11 95344-0048 / patricia@pecancom.com.br

BrightPath Bio and Cellistic Announces Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT cell




BrightPath Bio and Cellistic Announces Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT cell

TOKYO & MONT-SAINT-GUIBERT, Belgium–(BUSINESS WIRE)–BrightPath Bio (Tokyo Stock Exchange Growth 4594, “BrightPath”), a pioneer in iPS cell-derived Natural Killer T (“NKT”) cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, today announced a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials.

The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field.

“The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8⁺ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical-scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible,” stated Ken Nagai, CEO of BrightPath.

“While we have established a robust 2D culture-based manufacturing process, we have recognized the importance of anticipating the full scalability potential of the iPS cells from commercial perspective at an early stage. To address this need, we are committed to implement more scalable manufacturing solutions. Cellistic is well-positioned to meet this critical requirement with their unique 3D platform and extensive experiences in iPSC differentiation and scale-up of a variety of cell types,” Ken Nagai further noted. “We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors. This collaboration with Cellistic allows us to leverage their state-of-the-art development and manufacturing capabilities to accelerate the development of our BCMA CAR-NKT product.”

“We are excited to partner with BrightPath in the development of their revolutionary iPSC derived cell therapy,” said Gustavo Mahler, CEO of Cellistic. “Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need.”

The agreement marks a significant step forward in the industry’s pursuit of innovative and effective cell therapies, with both companies committed to advancing healthcare solutions that improve patient outcomes.

About BrightPath Biotherapeutics

BrightPath is a clinical stage biopharmaceutical company focused on the development of novel cancer immuno-therapies to transform cancer treatment for refractory or progressive cancers that cannot be treated with conventional standard therapies. BrightPath is actively involved in developing cell therapies, currently in clinical trials, and immunomodulatory antibodies.

For more information, visit www.brightpathbio.com/English

About Cellistic

Cellistic® specializes in process development and manufacture of immune cell therapies based on human induced pluripotent stem cell (iPSC) technology using their Pulse® and Echo® Platform. Its focus and expertise in iPSC reprogramming, gene editing using its proprietary STAR-CRISPR^™ technology and differentiation development, positions the company to be the partner of choice for innovative cell therapy developers to advance into clinic. Leveraging more than a decade of scientific and technical knowledge and experience, Cellistic possesses unique capabilities for the design and optimization of proprietary manufacturing platforms for iPSC- based cell therapies.

For more information, visit www.cellistic.com.

Contacts

BrightPath Biotherapeutics

Tokyo, Japan

irpr@brightpathbio.com

Cellistic

Mont-Saint-Guibert, Belgium

partnering@cellistic.com

Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma




Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma

If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the European Union

Positive opinion granted based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG^® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for:

• The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable;
• The treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies.

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the first quarter of 2025.

“Today’s positive CHMP opinion brings us closer to offering WELIREG, a first-in-class HIF-2α inhibitor, to certain patients in the European Union, in order to help address critical gaps in care for these patients,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are committed to providing innovative treatment options that address serious unmet needs for patients globally and look forward to the European Commission’s decision.”

The CHMP recommendation in VHL disease-associated tumors is based on objective response rate (ORR) and duration of response (DOR) results from the LITESPARK-004 trial. If approved, WELIREG would be the first and only systemic treatment for patients with VHL disease-associated tumors in the EU.

In August 2021, WELIREG was approved in the U.S. for the treatment of adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas or pNET not requiring immediate surgery based on the results from LITESPARK-004, an open-label clinical trial in 61 patients with VHL-associated RCC. In the LITESPARK-004 trial, WELIREG showed an ORR of 49% (95% CI, 36-62) in patients with VHL-associated RCC (n=30/61); all responses were partial responses (PR). Median DOR for these patients was not reached, with ongoing responses ranging from 2.8+ to 22+ months; among responders, 56% (n=17/30) maintained a response for at least 12 months.

Patients enrolled in LITESPARK-004 had other VHL-associated tumors, including CNS hemangioblastomas and pNET. In patients with VHL-associated CNS hemangioblastomas (n=24) in this trial, WELIREG showed an ORR of 63% (95% CI, 41-81) (n=15/24), with a complete response (CR) rate of 4% (n=1/24) and a PR rate of 58% (n=14/24). Median DOR for these patients was not reached, with ongoing responses ranging from 3.7+ to 22+ months; among responders, 73% (n=11/15) maintained a response for at least 12 months. In patients with VHL-associated pNET (n=12) in this trial, WELIREG showed an ORR of 83% (95% CI, 52-98) (n=10/12), with a CR rate of 17% (n=2/12) and a PR rate of 67% (n=8/12). Median DOR for these patients was not reached, with ongoing responses ranging from 11+ to 19+ months; among responders, 50% (n=5/10) maintained a response for at least 12 months.

The CHMP recommendation in advanced clear cell RCC that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF targeted therapies, is based on PFS and ORR results from the LITESPARK-005 trial, the first positive Phase 3 trial in these patients.

In December 2023, WELIREG was approved in the U.S. for the treatment of adult patients with advanced RCC following a PD-1 or PD-L1 inhibitor and a VEGF-TKI based on the results from LITESPARK-005, an open-label clinical trial in 746 patients with unresectable, locally advanced or metastatic clear cell RCC that progressed following PD-1 or PD-L1 checkpoint inhibitor and VEGF receptor targeted therapies either in sequence or in combination. In the trial, WELIREG reduced the risk of disease progression or death by 25% (HR=0.75 [95% CI, 0.63-0.90]; p=0.0008) versus everolimus in these patients. Median PFS was 5.6 months (95% CI, 3.9-7.0) for WELIREG versus 5.6 months (95% CI, 4.8-5.8) for everolimus. The ORR for WELIREG was 22% (n=82) (95% CI, 18-27), with a CR rate of 3% (n=10) and a PR rate of 19% (n=72), and the ORR for everolimus was 4% (n=13) (95% CI, 2-6), with no patients achieving a CR and a PR rate of 4% (n=13).

About von Hippel-Lindau disease

Von Hippel-Lindau disease is a rare genetic disease, which impacts an estimated 200,000 people worldwide and an estimated 10,000 to 15,000 people in Europe. Patients with VHL are at risk for recurrent, benign blood vessel tumors as well as some cancerous ones. The most commonly occurring tumor is RCC, a form of kidney cancer, which occurs in about 70% of patients with VHL disease.

About renal cell carcinoma

Renal cell carcinoma is by far the most common type of kidney cancer. In 2020, more than 130,000 new cases of RCC were diagnosed in Europe. Renal cell carcinoma is about twice as common in men than in women. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

About WELIREG^® (belzutifan) 40 mg tablets, for oral use

Indications in the U.S.

Certain von Hippel-Lindau (VHL) disease-associated tumors

WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Advanced Renal Cell Carcinoma (RCC)

WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Selected Safety Information for WELIREG

Warning: Embryo-Fetal Toxicity

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Anemia

WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment. Transfuse patients as clinically indicated. For patients with hemoglobin <8 g/dL, withhold WELIREG until ≥8 g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8 g/dL, then resume at a reduced dose or permanently discontinue WELIREG.

In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).

The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established.

In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced RCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

In LITESPARK-004, hypoxia occurred in 1.6% of patients.

In LITESPARK-005, hypoxia occurred in 15% of patients and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months).

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

In LITESPARK-004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

In LITESPARK-005, serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%).

WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%) and hemorrhage (0.5%).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%).

Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (33%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%).

Drug Interactions

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established.

Merck’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

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Please see Prescribing Information, including information for the Boxed Warning about embryo-fetal toxicity, for WELIREG (belzutifan) at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf and Medication Guide for WELIREG at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf.

Contacts

Media Contacts:

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Sensome Announces Data From Two New Studies Showing Clot-Sensing Guidewire Successfully Identifies Fresh Clot to Support Decision-Making in Peripheral Artery Disease Treatment




Sensome Announces Data From Two New Studies Showing Clot-Sensing Guidewire Successfully Identifies Fresh Clot to Support Decision-Making in Peripheral Artery Disease Treatment

Data showcased in two late-breaking clinical trial presentations at Paris Vascular Insights Course

PARIS–(BUSINESS WIRE)–#CLTI—Sensome, the pioneer of microsensing technology for instant intra-operative tissue analysis, today announced positive results from two studies of its Clotild® Smart Guidewire System demonstrating its ability to successfully identify “fresh” clot – thrombus rich in red blood cells (RBCs) – in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD procedures. Results from the SEPARATE and E-SEPARATE studies were presented today in a late-breaking trial session at the Paris Vascular Insights Course.

The Clotild clot-sensing guidewire integrates the world’s smallest electrical impedance sensor with machine learning. For PAD, the clot-sensing technology is being developed to instantly identify “fresh” clot and differentiate it from organized clot – thrombus poor in RBCs – as well as plaque, calcium and other tissue in real-time in order to inform individualized PAD treatment. The technology can be integrated into devices commonly used during PAD procedures, such as guidewires and catheters, and has the potential to enable the first device capable of objectively identifying “fresh” clot during a procedure without changing current workflow.

PAD affects 113 million people worldwide.¹ Yet, in current clinical practice, there is no simple method for physicians to easily determine what type of clot or tissue they are encountering when treating PAD. Reliably recognizing tissue type is an important factor in choosing the best treatment for any given patient – which varies from open surgery to endovascular procedures – and in achieving positive long-term patient outcomes. Today, identifying “fresh” clot with a high degree of certainty requires significant experience and expertise.

The prospective, single-arm SEPARATE study encompassed 17 patients treated by acknowledged PAD expert Koen Deloose, MD, Head of the Department of Vascular Surgery at AZ Sint Blasius Hospital, Belgium, where the Sensome clot-sensing technology was used in these patients to evaluate its ability to identify “fresh” clot. The study showed in a post-procedure analysis that there was a high level of agreement between the technology’s identification of “fresh” clot, the expert’s assessment of “fresh” clot and the treatment decisions appropriate for “fresh” clot.

“Differentiating among tissues in an obstructed vessel in order to achieve successful peripheral revascularization is often limited by indistinct angiographic imaging, inaccurate patient medical history and a lack of tactile guidewire feedback. The SEPARATE study shows us that Sensome’s clot-sensing technology could become a novel, real-time modality to reliably identify ‘fresh’ clot at an expert level in interventional procedures, with the potential to improve vessel preparation and treatment decision-making for physicians of all experience levels treating PAD,” said Dr. Deloose.

A second study of the Sensome technology – E-SEPARATE – was conducted with 15 PAD patients (scheduled for amputation or bypass) at Groupe Hospitalier Paris Saint-Joseph in France and had two interesting findings. The study showed the technology’s ability to differentiate “fresh” clot from other tissue collected from these PAD patients and examined ex-vivo. It also demonstrated an excellent correlation between the technology’s ability to determine the RBC content of clots collected from PAD patients with sub-acute and chronic lesions, and a histological analysis of the same clot by an outside core lab.

“The E-SEPARATE study findings clearly demonstrate that symptom onset is an unreliable way to judge clot composition prior to treating a patient with PAD. The clots retrieved from both chronic and sub-acute lesions contained both RBC-rich ‘fresh’ clot and organized RBC-poor clots. In light of this, it’s important for us to know the clot type to decide how to treat these patients…do we aspirate, dissolve the clot, or use another method? The Sensome technology has the potential to provide us with important information we are missing today to more effectively guide treatment and achieve better patient outcomes,” said Professor Yann Gouëffic, Professor of Vascular Surgery at Groupe Hospitalier Paris Saint-Joseph, France.

In two previous peer-reviewed publications, the company’s microsensor technology was shown to reliably predict the composition of red blood cells (RBC) in retrieved clot with good sensitivity and specificity consistent with histologic findings.^2,3

“The ability of our technology to accurately identify ‘fresh’ clot is an exciting achievement in the evolution of PAD treatment that we expect will improve operator success and patient experience,” said Sensome CEO Franz Bozsak. “We have now seen positive outcomes from our initial clinical work in PAD and ischemic stroke and anticipate similarly positive findings from our current study in lung cancer. We are enthusiastic about the potential of our real-time, intra-operative tissue analysis technology to enhance the efficacy of a variety of minimally invasive procedures that are currently limited by existing imaging modalities.”

ABOUT CLOTILD

The Clotild clot-sensing guidewire is based on electrical impedance spectroscopy, which measures the electrophysiologic characteristics of fluid or tissue in 360° surrounding the sensor, analyzed by Sensome’s proprietary predictive models. Impedance measurement of tissue is used today during such procedures as diagnosis of easily reached tumors and atrial fibrillation ablation, but it has never been used to examine thrombus due to the large size of existing technology. Sensome has miniaturized the technology down to fit on the distal part of a standard 0.014” guidewire, directly behind a soft, atraumatic tip, creating the world’s smallest electrical impedance sensor. The Clotild Smart Guidewire System has been designated as a Breakthrough Device by the FDA.

The Clotild Smart Guidewire System is considered an investigational device and is not approved for commercial use in the U.S or any other jurisdiction.

ABOUT SENSOME

Sensome, a clinical-stage healthtech start-up, has developed a patented, breakthrough microsensor technology that combines the world’s smallest impedance-based sensor with machine-learning algorithms to identify and characterize biological tissues in real-time. The technology is currently being studied in three different clinical indications: clot characterization (ischemic stroke), total occlusion characterization (peripheral vascular disease) and in-situ tool-in-lesion confirmation (lung cancer). Sensome intends to partner with leading medtech companies to design, manufacture and distribute smart medical devices integrating its proprietary microsensing technology. The company is partnered with leading guidewire manufacturer ASAHI INTECC for manufacturing of the Clotild Smart Guidewire System.

1. Kim, Min Seo et al. Global burden of peripheral artery disease and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Glob. Health. 2023;11(10): e1553–e1565.
2. Darcourt J, Brinjikji W, François O, et al. Identifying ex vivo acute ischemic stroke thrombus composition using electrochemical impedance spectroscopy. Interventional Neuroradiology. 2023;0(0). doi:10.1177/15910199231175377.
3. Sahin C, Giraud A, Jabrah D, et al. Electrical impedance measurements can identify red blood cell-rich content in acute ischemic stroke clots ex-vivo associated with first pass successful recanalization. Res Pract Thromb Haemost. 2024;8:e102373. DOI:https://doi.org/10.1016/j.rpth.2024.102373.

Contacts

MEDIA CONTACT:
Michelle McAdam, Chronic Communications, Inc.

michelle@chronic-comm.com
+1 310-902-1274

INVESTOR RELATIONS CONTACT:
Chuck Padala

chuck@lifesciadvisors.com
+1 646-627-839

Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits




Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits

– Only CAR T to Demonstrate Prolonged Overall Survival After Five Years Follow-Up in Relapsed/Refractory Mantle Cell Lymphoma –

– ZUMA-2 Analysis Shows 91% Overall Response Rate, Including 73% Complete Response Rate, in Bruton Tyrosine Kinase Inhibitor-Naïve R/R MCL Patients –

– Real-World Evidence Analysis Shows High Effectiveness and Safety Profile Consistent with ZUMA-3 in Broader Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia Population –

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), announced results today from four analyses that continue to demonstrate the durability of response of Tecartus^® (brexucabtagene autoleucel) in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

The data presented include an oral presentation (Abstract # 748) of a primary analysis of ZUMA-2 cohort 3 demonstrating an overall response rate (ORR) of 91% and complete response (CR) rate of 73% in Bruton tyrosine kinase inhibitor (BTKi)-naïve patients with R/R MCL. Long-term follow-up of patients in ZUMA-2 cohorts 1 and 2 (Abstract #4388), showed that 39% of patients with R/R MCL were still alive after five years, underscoring Tecartus as the only CAR T to have five-year follow-up data in this patient population. In addition, real-world evidence outcomes in adults with R/R B-ALL treated with Tecartus (Abstract # 5092 and #4193) demonstrated a high effectiveness and consistent safety profile in a broader patient population than the pivotal ZUMA-3 study.

“We are proud to share long-term data that continue to underscore durable efficacy and survival benefits with one-time treatment of Tecartus in people with relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia,” said Dominique Tonelli, VP, Global Head of Medical Affairs, Kite. “This compelling efficacy is consistent across patient subgroups and is observed in the latest follow-up analyses. Additionally, Kite’s industry-leading manufacturing shows that Tecartus can be successfully manufactured and elicit robust objective response rates regardless of white blood cell or lymphocyte count.”

Detailed Information on Tecartus Abstracts:

Abstract #748

Primary Analysis of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-Cel) in Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Were Naive to Bruton Tyrosine Kinase Inhibitors (BTKi)

ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study that investigated leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BKTi ibrutinib or acalabrutinib. Cohort 3 of ZUMA-2 assesses treatment of Tecartus in 86 patients who have not received treatment with a BTKi.

With a median follow-up of 15.5 months (range, 1.4-27.1), the primary endpoint was met with an ORR of 91% (95% CI, 82.5-95.9; P<.0001). Seventy three percent (95% CI, 62.6-82.2) of patients had a CR, 17% (95% CI, 10.1-27.1) had a partial response (PR), 3% (95% CI, 0.7-9.9) had stable disease, and 3% (95% CI, 0.7-9.9) had progressive disease (PD) as best response to Tecartus.

This efficacy was durable: Preliminary follow-up shows median duration of all time-to-event endpoints has not been met. The 12-month (95% CI) duration of response (DOR), progression-free survival (PFS), and overall survival (OS) rates were 80% (69.1-87.9), 75% (64.5-83.4), and 90% (80.7-94.4), respectively.

“For years, we have seen strong, durable responses with brexu-cel from patients previously exposed to BTKi treatment,” said Dr. Tom van Meerten, lead investigator, University Medical Center Groningen, Netherlands.​ “Patients with high-risk relapsed/refractory mantle cell lymphoma have poor outcomes, so it is encouraging to see positive results even in people who are BTKi-naïve. The high overall response rate, complete responses, and durable benefit demonstrated in ZUMA-2 cohort 3 indicate that brexu-cel can be used earlier in the treatment of relapsed/refractory mantle cell lymphoma.”

No new safety signals were detected, with a low rate of Grade ≥ 3 cytokine release syndrome (CRS) occurring in five patients (6%) and an expected rate of Grade ≥ 3 neurological events (immune effector cell-associated neurotoxicity syndrome [ICANS]), occurring in 18 patients (21%).

Abstract #4388

Five-Year Outcomes of Patients (Pts) With Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated With Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 Cohorts 1 and 2

The abstract features five-year follow-up data from cohort 1 of the ZUMA-2 study. Cohort 1 enrolled 68 patients who received the pivotal dose (2×10⁶ anti-CD19 CAR T cells/kg) of Tecartus and received at least two prior lines of therapy. In addition, cohort 2 was designed in 2018 to assess a lower dose (0.5 x 10⁶ anti-CD19 CAR T cells/kg) in the same line setting; however, the risk/benefit ratio of the cohort 1 dose was deemed optimal before cohort 2 reached full enrollment. In the primary analysis of cohort 2, 14 patients treated with Tecartus with a median follow-up of 16.0 (13.9-18.0) months demonstrated an ORR of 93% (95% CI, 66.1-99.8) per independent radiology review committee (IRRC); 64% had a CR (95% CI, 35.1-87.2), and 29% had a PR (95% CI, 8.4-58.1).

In the five-year analysis, median follow-up for cohorts 1 and 2 were 67.8 months (58.2-88.6) and 72.3 months (70.1-74.3), respectively. Median (95% CI) investigator-assessed DOR and PFS were 36.5 months (17.7-48.9; n=60; 17 patients in ongoing response, all CR) and 25.3 months (12.7-46.6; n=68) in cohort 1; and 57.5 months (4.7-not estimable [NE]; n=12; 3 patients in ongoing response, all CR) and 29.5 months (3.3-NE; n=14) in cohort 2. Median OS (95% CI) and 60-month OS rates (95% CI) were 46.5 months (24.9- 60.2) and 39% (26.7-50.1) in cohort 1, respectively; and not reached (9.4-NE) and 54% (23.8-76.2) in cohort 2, respectively.

No new safety signals were detected, and no secondary T‑cell malignancies were reported at any time in ZUMA-2

“More than three years after its approval, brexu-cel continues to deliver in relapsed/refractory mantle cell lymphoma,” said Dr. Michael Wang, lead investigator, The University of Texas MD Anderson Cancer Center. “It is encouraging to see these results in a heavily pre-treated population and consistency across both cohorts.”

Abstract # 5092

Real-World Outcomes for Brexucabtagene Autoleucel (Brexu-Cel) Treatment in Patients (Pts) With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) by High-Risk Features and Prior Treatments: Updated Evidence From the CIBMTR Registry

This real-world analysis of 242 evaluable adult R/R B-ALL patients treated with Tecartus from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry demonstrated the high effectiveness of CAR T-cell therapy in a broad R/R B-ALL patient population.

With a median follow-up of 7.2 months, the CR/CRi (CR with incomplete hematologic recovery) after Tecartus treatment was 80% (95% CI, 75-85; 68% [60-76] for 145 patients not in CR/CRi pre-infusion). Estimated six-month rates (95% CI) of DOR were 67% (58-74; n=192; 66% [51-77] in 99 patients not in CR/CRi pre-infusion), six-month rates of relapse-free survival (RFS) were 55% (95% CI, 48-62; n=242), and six-month rates of OS were 80% (95% CI, 74-84; n=242).

Among all patients (n=242), rates of any grade CRS and ICANS by 100 days were 81% (95% CI, 76-86; 13% Grade ≥3 [95% CI, 9-18]), and 46% (95% CI, 39-52; 24% Grade ≥3 [95% CI, 19-30]), respectively. Day 30 prolonged thrombocytopenia and neutropenia rates were 30% (95% CI, 24-36) and 34% (95% CI, 28-41), respectively.

“In this real-world analysis of brexu-cel, we see an efficacy and safety profile consistent with the findings of the pivotal ZUMA-3 study in relapsed/refractory B-cell acute lymphoblastic leukemia, but in a broader patient population,” said Dr. Kitsada Wudhikarn​, lead investigator, Associate Professor of Medicine, Division of Hematology, Chulalongkorn University, Bangkok, Thailand. “Notably, the high level of effectiveness seen in the patient registry was consistent across prior treatments and most high-risk features. These findings provide further evidence of the substantial utility of brexu-cel in the treatment of this challenging blood cancer.”

Abstract #4193

Impact of Disease Burden, CAR-T Expansion, and Mononuclear Cell Recovery on Overall Response and Duration of Response in ZUMA-3 Pivotal Study

In the analysis, researchers evaluated clinical and pharmacokinetic/pharmacodynamic data in the context of best response and durability of response among 78 R/R B-ALL patients who received Tecartus in the ZUMA-3 study.

Tecartus was successfully manufactured from apheresis material and elicited robust rates of objective response regardless of white blood cell or lymphocyte count. Half of the patients who achieved duration of response lasting >12 months had a bone marrow blast percentage of ≥50%, demonstrating the potential of Tecartus to benefit patients regardless of disease burden.

Additionally, CAR expansion within the first month post Tecartus infusion is associated with best response as well as durable response, even without persistence of CAR T cells. Recovery of mononuclear cells post infusion also appeared higher in subjects with longer response. These findings have the potential to support treatment decision-making, such as the need for subsequent allogeneic stem cell transplant as consolidation of remission.

About ZUMA-2

The ongoing, single-arm, open-label ZUMA-2 pivotal study enrolled 86 adult patients with relapsed or refractory MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of CR and partial responses as assessed by an Independent Radiologic Review Committee (IRRC).

Secondary endpoints include DOR, best objective response, PFS, OS, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (U.S., Canada, Europe), single-arm, open-label, registrational Phase 1/2 study of Tecartus in adult patients (≥18 years old) with B-ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and RFS, OS, minimal residual disease negativity rate, and allogeneic stem cell transplantation rate were assessed as secondary endpoints.

About MCL

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Approximately 33,000 people worldwide are diagnosed with MCL each year. MCL is highly aggressive following relapse, with many patients’ disease progressing following therapy.

About ALL

ALL is an aggressive and rare type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. While 80% of ALL occurs in children, it represents a devastating disease in adults. In adults, B-cell precursor ALL is the most common form, accounting for 75% of cases. Survival rates in adults with R/R B-ALL are poor, with median OS at less than eight months.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

• Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
• Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
  
  This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES

• Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids as needed.
• T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies
• Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system) CRS in 26% of patients. Three patients with ALL had ongoing CRS events at the time of death. The median time to onset of CRS was five days (range: 1 to 12 days) and the median duration of CRS was eight days (range: 2 to 63 days) for patients with ALL.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 87% (68/78) of patients with ALL, including ≥ Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

• Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS.
• Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of “febrile neutropenia” (11 (14%)) plus the concurrent events of “fever” and “neutropenia” (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions (≥ 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions (≥ 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation.

Contacts

Blair Baumwell, Gilead Media

public_affairs@gilead.com

Jacquie Ross, Investors

investor_relations@gilead.com

Read full story here

Cencora Closes $1.8 Billion Senior Notes Offering




Cencora Closes $1.8 Billion Senior Notes Offering

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Cencora, Inc. (NYSE: COR) today announced the closing of its public offering of $500,000,000 aggregate principal amount of its 4.625% Senior Notes due December 15, 2027 (the “2027 Notes”), $600,000,000 aggregate principal amount of its 4.850% Senior Notes due December 15, 2029 (the “2029 Notes”) and $700,000,000 aggregate principal amount of its 5.150% Senior Notes due February 15, 2035 (the “2035 Notes” and, together with the 2027 Notes and the 2029 Notes, the “Notes”), in an underwritten registered public offering. The offering was made pursuant to an effective shelf registration statement Cencora filed with the Securities and Exchange Commission (the “SEC”) on November 26, 2024.

Cencora intends to use the net proceeds from the offering to finance the acquisition of the majority of Retina Consultants of America and related fees and expenses, and for general corporate purposes.

The joint book-running managers for the offering were BofA Securities, Inc., Citigroup Global Markets Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC. Cencora filed a final prospectus supplement and an accompanying prospectus with the SEC in connection with the offering of the Notes. Copies of these materials can be made available by contacting: BofA Securities, Inc., NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, email: dg.prospectus_requests@bofa.com or telephone: 1-800-294-1322; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, email: prospectus@citi.com or telephone: 1-800-831-9146; J.P. Morgan Securities LLC, 383 Madison Avenue, New York, New York 10179, Attention: Investment Grade Syndicate Desk, 3rd Floor, telephone collect at 1-212-834-4533; and Wells Fargo Securities, LLC, 608 2nd Avenue South, Suite 1000, 608 2nd Avenue South, Suite 1000, Minneapolis, Minnesota 55402, Attention: WFS Customer Service, email: wfscustomerservice@wellsfargo.com or telephone: 1-800-645-3751. Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the SEC’s web site at www.sec.gov.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any sale of the Notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cencora

Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #10 on the Fortune 500 and #18 on the Global Fortune 500 with more than $290 billion in annual revenue.

Cencora’s Cautionary Note Regarding Forward-Looking Statements

Certain of the statements contained in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act”). Words such as “aim,” “anticipate,” “believe,” “can,” “continue,” “could,”, “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “opportunity,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “sustain,” “synergy,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances and speak only as of the date hereof. These statements are not guarantees of future performance and are based on assumptions and estimates that could prove incorrect or could cause actual results to vary materially from those indicated. A more detailed discussion of the risks and uncertainties that could cause our actual results to differ materially from those indicated is included in the “Risk Factors” and “Management’s Discussion and Analysis” sections in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2024 and elsewhere in that report and other reports filed by the Company pursuant to the Securities Exchange Act. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by the federal securities laws.

Contacts

Bennett S. Murphy

Senior Vice President, Head of Investor Relations & Treasury

610-727-3693

bennett.murphy@cencora.com

Martin Madaus Elected to Hologic Board of Directors




Martin Madaus Elected to Hologic Board of Directors

MARLBOROUGH, Mass.–(BUSINESS WIRE)–$HOLX #boardofdirectors–Hologic, Inc. (Nasdaq: HOLX) announced today that Martin Madaus has been elected to the Company’s Board of Directors, effective December 6, 2024. Dr. Madaus was also appointed to the Compensation Committee and the Nominating and Corporate Governance Committee effective December 6, 2024.

Dr. Madaus, who has more than 30 years of diagnostics and life sciences industry experience, currently serves as an Operating Executive at the Carlyle Group, a global investment firm, which he joined in February 2019. Prior to joining the Carlyle Group, Dr. Madaus held the role of Chairman and Chief Executive Officer at Ortho Clinical Diagnostics, Inc., a diagnostics company that makes products and diagnostic testing equipment for blood testing. Dr. Madaus previously served as the Chairman, President and Chief Executive Officer of Milipore Corporation, a life sciences company serving the bioscience research and biopharmaceutical manufacturing industry, until its acquisition by Merck KGaA in 2010.

“We’re delighted to welcome Martin to Hologic’s Board of Directors,” said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer. “With his deep industry, technical, business and international experiences, Martin represents yet another strong addition to our deep and experienced Board.”

Dr. Madaus received a Doctor of Veterinary Medicine from the University of Munich in Germany and a Ph.D. in Veterinary Medicine from the Veterinary School of Hanover in Germany.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Forward Looking Statements

This press release contains forward-looking information that involves risks and uncertainties, including statements about the Company’s plans, objectives, expectations and intentions, and statements regarding the Company’s Board of Directors. These forward-looking statements are based on assumptions made by the Company as of this date and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. These risks include, but are not limited to, the risk that the Company may not be able to attract and retain qualified Board members or executives. These risks are not exhaustive. Other factors that could adversely affect the Company’s business and prospects are described in the filings made by the Company with the SEC. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented here to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

SOURCE: Hologic, Inc.

Contacts

Investor Contact:
Ryan Simon

+1 858.410.8514

ryan.simon@hologic.com

Media Contact:
Bridget Perry

+1 508.263.8654

bridget.perry@hologic.com

Synthetic Biology Focused Insights Report 2024-2029 with Competitive Analysis of 38 Vendors – Agilent, Codexis, Eurofins Scientific, Illumina, Novozymes, and Thermo Fisher Scientific Lead – ResearchAndMarkets.com




Synthetic Biology Focused Insights Report 2024-2029 with Competitive Analysis of 38 Vendors – Agilent, Codexis, Eurofins Scientific, Illumina, Novozymes, and Thermo Fisher Scientific Lead – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Synthetic Biology Market – Focused Insights 2024-2029” report has been added to ResearchAndMarkets.com’s offering.

The Synthetic Biology Market was valued at USD 15.20 Billion in 2023, and is expected to reach USD 59.91 Billion by 2029, rising at a CAGR of 25.68%

The global synthetic biology market report contains exclusive data on 38 vendors. The market is highly competitive, with major players like Agilent Technologies, Codexis, Eurofins Scientific, Illumina, Novozymes, and Thermo Fisher Scientific holding significant market shares. These companies face strong competition from emerging and established players, driving continuous technological innovation and product development across various sectors such as healthcare, industrial applications, food and beverages, agriculture, and environmental solutions. To maintain their market position and expand their presence, key players in the synthetic biology market focus on organic growth strategies, including launching new products, innovating existing ones, and securing patents for new technologies.

North America dominates the global synthetic biology market share. In North America, the synthetic biology landscape is particularly vibrant, with over 530 regenerative medicine companies, including those specializing in cell and gene therapy and stem cell-based medicines. These companies are heavily involved in research and development, utilizing synthetic biology products to advance medical treatments.

The US, in particular, is a global leader in conducting cell and gene therapy-based clinical trials, with a growing number of patients opting for these innovative treatments. Regulatory approvals for these therapies are also more frequent in North America, further driving the region’s leadership in this field.

MARKET TRENDS & DRIVERS

Increasing Applications of Synthetic Biology Products

Synthetic biology is revolutionizing real-world applications across multiple industries, including food, pharmaceuticals, and agriculture. From 2000 to 2021, significant advances in synthetic biology tools have enabled biotechnology, pharmaceutical, and agriculture companies to develop innovative products with real-world impact. Impossible Foods has transformed the plant-based food market by engineering the yeast Pichia pastoris to produce soy leghemoglobin, a key component in replicating the taste and experience of a traditional hamburger. Advances in metabolic engineering have efficiently transferred large metabolic pathways from natural sources to production hosts like yeast.

This breakthrough enables the production of plant-based burgers with authentic meaty flavors, creating a new category of food products that appeal to both consumers and environmental advocates. As synthetic biology advances, the next decade promises even greater innovations that will enhance the performance and affordability of products across life sciences, pharmaceuticals, and industrial sectors. The field’s growing influence offers significant opportunities for companies looking to harness its transformative potential.

The Rise of Bio-Based Products and Sustainable Energy Solutions

The synthetic biology sector is transforming, driven by the growing global demand for bio-based products and sustainable energy solutions. This growth is propelled by breakthroughs in genetic engineering, metabolic engineering, and synthetic biology tools, which have significantly enhanced the ability of researchers to manipulate microorganisms to produce high-value chemicals and fuels. These microorganisms are now engineered to efficiently convert renewable resources, such as biomass, algae, and waste materials, into diverse valuable products.

This shift marks a departure from traditional methods that relied heavily on non-renewable resources, offering a more sustainable and environmentally friendly approach to manufacturing. One of the most notable impacts of these advancements is the ability to produce biofuels from non-food biomass. This innovation provides a renewable alternative to fossil fuels and helps address pressing issues of energy security and environmental sustainability. By utilizing resources that would otherwise contribute to waste, synthetic biology enables the creation of biofuels with a significantly lower carbon footprint than conventional fuels.

Rising Use of Synthetic Biology in Multiplexed Diagnostics and Therapeutic Genome Editing

The field of synthetic biology is witnessing significant growth in its application for multiplexed diagnostics and therapeutic genome editing. This trend is driven by the technology’s ability to engineer highly precise, customizable solutions that can address complex healthcare challenges. Multiplexed diagnostics, which involve the simultaneous detection and analysis of multiple biomarkers or pathogens, are becoming increasingly sophisticated thanks to synthetic biology.

This technology allows for the design of synthetic gene circuits and CRISPR-based systems to identify multiple disease indicators in a single test, leading to faster, more accurate diagnoses. In therapeutic genome editing, synthetic biology revolutionizes how genetic disorders are treated. By leveraging tools like CRISPR-Cas9, researchers can target and edit multiple genes simultaneously, offering potential cures for previously difficult or impossible conditions.

These advancements are particularly impactful in developing personalized medicine, where therapies can be tailored to an individual’s unique genetic makeup. The growing use of synthetic biology in these areas is enhancing the effectiveness of diagnostics and treatments, reducing costs, and improving accessibility.

INDUSTRY RESTRAINTS

Threat to Existing Technologies

Synthetic biology start-ups and established chemical companies invest in various technologies to enter the market. Innovations in synthetic biology will hurt existing industries. In most cases, the more beneficial technology is widely accepted in the market. Many companies invest in various synthetic biology applications-based products. For instance, high-income countries like the US and the UK have more market patents than middle-income countries like India. These innovations largely impact their economies. Innovations in synthetic biology will hurt existing industries and can disrupt their processes.

SEGMENTATION HIGHLIGHTS

INSIGHTS BY TOOL

The global synthetic biology market by tool is segmented into oligonucleotides and synthetic DNA, enzymes, cloning technology kits, xeno-nucleic acids, and chassis organisms. The oligonucleotides and synthetic DNA segment holds the largest market share. Oligonucleotides, short DNA or RNA molecules, play a critical role in genetic testing, research, and forensics due to their stable, efficient, and rapid synthesis.

INSIGHTS BY TECHNOLOGY

The global synthetic biology market by technology is categorized into enabling and enabled. The enabling technology shows significant growth, with the fastest-growing CAGR during the forecast period. Enabling technologies are pivotal in advancing the global synthetic biology market, comprising key areas such as gene synthesis, bioinformatics, genome engineering, cloning technology, mutagenesis, gene measurement and modeling, and microfluidics.

INSIGHTS BY APPLICATION

Based on the application, the healthcare application accounted for the largest global synthetic biology market share. Basic life sciences are instrumental in the growth of synthetic biology, providing a foundation for innovation and the development of new tools and techniques. The collaboration between scientists, engineers, and chemists in this field has led to the creation of a wide array of tools that advance the goals of synthetic biology.

INSIGHTS BY END-USER

Based on the end-user, the pharma and biotech companies show the highest growth in the global synthetic biology market. Pharma and biotech companies have been pivotal in the early successes of synthetic biology, largely due to the inherent connection between synthetic biology and the production of small-molecule drugs.

KEY QUESTIONS ANSWERED:

• What are the key drivers of the global synthetic biology market?
• How big is the global synthetic biology market?
• Which region dominates the global synthetic biology market?
• What is the growth rate of the global synthetic biology market?
• Who are the major players in the global synthetic biology market?

Key Attributes:

VENDOR LANDSCAPE

Key Vendors

• Agilent Technologies
• Codexis
• Eurofins Scientific
• Illumina
• Novozymes
• Thermo Fisher Scientific

Other Prominent Vendors

• Amyris
• ATUM
• Bio-Rad Laboratories
• Creative Biogene
• Creative Enzymes
• Cyrus Biotechnology
• Editas Medicine
• Genomatica
• Genscript
• Ginkgo Bioworks
• Integrated DNA Technologies
• LGC Biosearch Technologies
• New England Biolabs
• OriGene Technologies
• Precigen
• Sentebiolab
• SynbiCITE
• Synthego
• Tessera Therapeutics
• Viridos
• Asimov
• Twist Bioscience
• Mammoth Biosciences
• ElevateBio
• Dupont
• DSM
• Bota Biosciences
• Kiverdi
• Merck KGaA
• Synlogic
• Huee
• Upside Foods

For more information about this report visit https://www.researchandmarkets.com/r/x0rpwi

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