Samsung Bioepis Announces US Launch of PYZCHIVA® (ustekinumab-ttwe), Biosimilar to Stelara




Samsung Bioepis Announces US Launch of PYZCHIVA® (ustekinumab-ttwe), Biosimilar to Stelara

• PYZCHIVA becomes Samsung Bioepis’ fifth biosimilar and third immunology biosimilar to be launched in the US
• Commercialized by Sandoz, PYZCHIVA offers three different strengths

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that PYZCHIVA^® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab), is now available in the United States. PYZCHIVA has been approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Through Samsung Bioepis’ commercialization partner Sandoz, PYZCHIVA is available to patients across US starting today in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials.

“The launch of PYZCHIVA is a significant milestone for both Samsung Bioepis and for millions of patients living with inflammatory conditions in the US. The expanded treatment options in the market would allow for reduced healthcare costs, ultimately contributing to a more sustainable healthcare system,” said Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis. “We remain steadfast in our commitment to serve patients in need through our continued innovation to make medicine more accessible.”

Samsung Bioepis and Sandoz entered into a commercialization agreement for PYZCHIVA in September 2023 for the US. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

Samsung Bioepis has a total of 11 biosimilars in its products and pipeline portfolio across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, Samsung Bioepis has 10 biosimilars approved in the US and five commercially available.

About PYZCHIVA® (ustekinumab-ttwe) injection, for subcutaneous (45 mg/0.5 mL and 90 mg/mL) or intravenous (130 mg/26 mL solution) use

PYZCHIVA (ustekinumab-ttwe) is indicated for:

• Plaque Psoriasis: PYZCHIVA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Psoriatic Arthritis: PYZCHIVA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• Crohn’s Disease: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.
• Ulcerative Colitis: PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

SELECTED IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

PYZCHIVA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in PYZCHIVA.

WARNINGS AND PRECAUTIONS

Infections

Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products.

Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical studies included the following:

• Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections.
• Psoriatic arthritis: cholecystitis.
• Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
• Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.

Avoid initiating treatment with PYZCHIVA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of PYZCHIVA in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with PYZCHIVA and discontinue PYZCHIVA for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances).

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis infection prior to initiating treatment with PYZCHIVA.

Avoid administering PYZCHIVA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering PYZCHIVA. Consider anti-tuberculosis therapy prior to initiation of PYZCHIVA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving PYZCHIVA for signs and symptoms of active tuberculosis during and after treatment.

Malignancies

Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical studies. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy.

The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving PYZCHIVA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue PYZCHIVA.

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products.

Monitor all patients treated with PYZCHIVA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue PYZCHIVA.

Immunizations

Prior to initiating therapy with PYZCHIVA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with PYZCHIVA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with PYZCHIVA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving PYZCHIVA because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of PYZCHIVA may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue PYZCHIVA and institute appropriate treatment.

Most common adverse reactions are:

• Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
• Crohn’s Disease, induction (≥3%): vomiting.
• Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
• Ulcerative colitis, induction (≥3%): nasopharyngitis
• Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea

Please see Full Prescribing Information for PYZCHIVA^® (ustekinumab-ttwe) HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

Contacts

MEDIA CONTACT
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

CORRECTING and REPLACING Agenus’ BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting




CORRECTING and REPLACING Agenus’ BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting

LEXINGTON, Mass.–(BUSINESS WIRE)–Proffered Papers, Session 2, Session Date and Time of release dated February 12, 2025, should read: Monday, February 24^th, 1:39-1:45 p.m. PST (instead of Tuesday, February 25^th, 1:00-1:45 p.m. PST).

The updated release reads:

AGENUS’ BOT/BAL SELECTED FOR TWO PRESENTATIONS AT UPCOMING AACR IO ANNUAL MEETING

Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that BOT/BAL will be featured in two presentations at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California. An oral presentation will highlight interim data from the ongoing Phase 2 study of botensilimab and balstilimab (BOT/BAL) in combination with MiNK Therapeutics’ iNKT cell therapy, AgenT-797, in patients with refractory (2L+) gastric cancer (NCT06251973). A Trial-in-Progress (TiP) poster will feature data from the ongoing Phase 1/2 study of BOT/BAL in first-line MSS colorectal cancer (NCT06268015).

Presentation Details:

Abstract Title: First-line botensilimab and balstilimab optimization in microsatellite stable colorectal cancer (MSS-CRC) without liver metastasis (BBOpCo)

Session: Poster Session A

Session Date and Time: Monday, February 24^th, 1:45-4:45 p.m. PST

Abstract Title: Biomarker analysis from phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC)

Session: Proffered Papers, Session 2

Session Date and Time: Monday, February 24^th, 1:39-1:45 p.m. PST

About Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

About Botensilimab (BOT)

Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies.

Approximately 1,100 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

About AgenT-797

AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy, leveraging a unique innate immune cell type that serves as a master regulator of both innate and adaptive immunity. iNKTs combine the cytotoxic capabilities of natural killer (NK) cells with the adaptive memory of T cells, enabling them to elicit a broad range of immune responses in a pathogen-agnostic manner.

AgenT-797 is a scalable, “off-the-shelf” cell therapy product, manufactured by MiNK Therapeutics in Lexington, MA, to deliver transformative treatment solutions to patients.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contacts

Investors
917-362-1370

investor@agenusbio.com

Media
510-323-5188

communications@agenusbio.com

Celltrion Receives EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® (tocilizumab)




Celltrion Receives EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® (tocilizumab)

• Avtozma^® (CT-P47), a biosimilar referencing RoActemra^® (tocilizumab) is approved by the European Commission (EC) for all indications of the reference product¹
• EC approval is based on a comprehensive data package demonstrating Avtozma^®’s biosimilarity to RoActemra^®2,3
• Celltrion’s biosimilar portfolio continues to grow, expanding treatment options to meet the needs of people with immune diseases

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma^® (CT-P47), a biosimilar referencing RoActemra^® (tocilizumab). Avtozma^® has been approved for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).¹ The approval further strengthens Celltrion’s growing immunology portfolio.

“Today’s approval of Avtozma^®, a biosimilar to RoActemra^®, marks a critical step in Celltrion’s mission to provide European healthcare systems with affordable, effective solutions for immunological disorders. By leveraging our integrated operations, we strengthen the stability of supply chains and enhance collaboration with European healthcare professionals,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “We are committed to delivering value-driven solutions tailored to the unique needs of the European market.”

The EC approval on Avtozma^® was supported by a comprehensive data package and totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma^® and the reference product. The primary endpoint was met in terms of mean change from baseline in Disease Activity Score (DAS) using 28 joints (DAS28)-ESR at Week 12, and the final results supported comparability in secondary efficacy, pharmacokinetics (PK), safety and immunogenicity results between Avtozma^® and RoActemra^®.^2,3

Avtozma^® is Celltrion’s twelfth biosimilar product approved by the EC, following the approval of Remsima^® (intravenous infliximab), Remsima^® SC (subcutaneous infliximab), Yuflyma^® (adalimumab), SteQeyma^® (ustekinumab), Truxima^® (rituximab), Herzuma^® (trastuzumab), Vegzelma^® (bevacizumab), Omlyclo^® (omalizumab), Eydenzelt^® (aflibercept), Stoboclo^® and Osenvelt^® (denosumab).

About CT-P47 Phase III Clinical Trial^2,3

This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma^® (CT-P47) and RoActemra^® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52.

About Avtozma^® (CT-P47, biosimilar tocilizumab)

Avtozma^®, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of Avtozma^® compared to the reference product^2,3, Avtozma^® has been approved for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).¹ Avtozma^® was also approved by the U.S. FDA in January 2025.

About Celltrion

Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries’ management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.

Trademarks

Avtozma^® is a registered trademark of Celltrion, Inc., used under license.

RoActemra^® is a registered trademark of Chugai Pharmaceutical Co., Ltd.

References

_______________________________

¹ European Medicines Agency Summary of Product Characteristics (SmPC), Avtozma. [Last accessed February 2025].

² Smolen JS et al., Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4), e004514. Available at: https://rmdopen.bmj.com/content/10/4/e004514.abstract [Last accessed February 2025]

³ Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed February 2025]

Contacts

Donna Gandhi

dgandhi@hanovercomms.com
+44 (0) 7827 053 502

Leaf Health Founder & CEO, Robert Shelley, Passes Away




Leaf Health Founder & CEO, Robert Shelley, Passes Away

LEANDER, Texas–(BUSINESS WIRE)–With profound sadness, Leaf Health announces the passing of our founder, CEO, and dear friend, Robert Shelley, after a courageous battle with cancer and its complications.

For more than 30 years, Rob dedicated his career to improving access to and cost management of prescription drugs in the pharmacy benefits space. In 2017, he founded Leaf Health, driven by a vision to create a Pharmacy Benefit Management (PBM) consultancy that would provide innovative strategies to help health plan sponsors rein in the rising costs of prescription medications—without compromising the quality of care. Under his leadership, Leaf Health flourished, reflecting his expertise, dedication, and unwavering commitment to the industry.

Beyond his professional achievements, Rob was an avid runner, swimmer, and gifted storyteller. Whether addressing a room full of industry leaders or sharing tales from his latest travel adventure over lunch, he had a way with words that captivated and inspired those around him.

Leaf Health President and Rob’s wife of eight years—Tiffany Shelley shares a heartfelt tribute to the incredible person he was:

“Rob was not only my partner in business—he was my partner in life. He was the most intelligent, driven, reliable, thoughtful, and genuinely kind person I have ever known. His passion for life was contagious, making every day something to look forward to. He was the kind of man, husband, father, friend, and confidant that most can only aspire to be. Leaf Health was Rob’s dream, and I know I speak for our entire team when I say we are committed to carrying that vision forward. What started as a seed has now blossomed into something beautiful, and only time will tell how tall it will grow.”

Please join us in keeping Tiffany and the entire Shelley family in our thoughts and prayers during this difficult time.

About Leaf Health

Leveraging more than three decades of industry experience, our team utilizes a high-touch, customer-focused approach to create and execute a customized plan that meets the unique needs of every client. Our primary goal at Leaf Health is to help our clients rein in the rising costs of prescription drugs by providing innovative, results-driven strategies for efficiently managing their pharmacy benefits in the most cost-effective way—without sacrificing patient care. We are your advocate. Learn more at leafhealth.net.

Contacts

Hugh Gallagher

Senior Vice President

hgallagher@leafhealth.net
215.480.4060

California Plasma Coalition Calls for Increased Access to Life-Saving Medicines




California Plasma Coalition Calls for Increased Access to Life-Saving Medicines

Patients, plasma donors, health care professionals, and community advocates are working together to address barriers to source plasma donations and help save more lives.

SACRAMENTO, Calif.–(BUSINESS WIRE)–The California Plasma Coalition (CalPlasma) today launched a statewide campaign to raise awareness of the vital role that plasma donations play in saving lives of Californians and patients around the world.

Plasma-derived medicines are life-changing and life-saving for people living with complex and rare conditions, including primary immunodeficiency diseases, alpha-1 antitrypsin deficiency, hereditary angioedema, chronic inflammatory demyelinating polyneuropathy, hemophilia and Von Willebrand disease, Kawasaki disease, and more. To care for children and adults living with these conditions, millions of plasma donations are needed each year in California.

Plasma, the straw-colored liquid part of blood, is packed with hundreds of essential proteins that support critical bodily functions. Because plasma and its lifesaving proteins help protect against infections, replace lost fluids, preserve lung function, and reduce the risk of life-threatening pregnancy complications, individuals with rare, chronic, and life-threatening conditions, and those facing everyday medical needs such as surgeries, trauma care, transplants, and pregnancies, rely on plasma-derived medicines to not just survive, but thrive.

As more patients are diagnosed with rare diseases and scientists continue to explore new ways to utilize plasma in treating complex conditions, the clinical need for plasma-derived medicines continues to rise in California and globally. To increase access to these life-saving medicines, CalPlasma is working to improve plasma education and awareness throughout the state.

“The importance of plasma cannot be overstated. Plasma cannot be reproduced in a lab, it can only come from generous donors who dedicate their time to saving lives,” said Anita Brikman, President and CEO of the Plasma Protein Therapeutics Association (PPTA). “CalPlasma is building a movement to break down barriers and help ensure a robust supply of lifesaving plasma-derived medicines. If you feel the same, join us in taking action. Advocate, donate, and spread the word to help save lives.”

CalPlasma is proud to partner with a growing number of organizations to amplify the urgent need for plasma, including:

• Albie Aware Breast Cancer Foundation
• Alpha 1 Foundation
• California Rare Disease Access Coalition
• GBS | CIDP Foundation International
• Hemophilia Council of California
• Immune Deficiency Foundation
• Liver Coalition
• Patient Advocates United in San Diego County

About California Plasma Coalition

The California Plasma Coalition (CalPlasma) is a dedicated community of patients, donors, health care professionals, and advocates working to ensure that every Californian has timely access to life-saving plasma medicines when they need them most. Learn more by visiting CalPlasma.org.

Contacts

Kaitlin Perry

media@calplasma.org
(916) 834-1300

TROP2 Antibody Market Report: Clinical Trials Pave the Way, Revolutionizing Cancer Treatment – ResearchAndMarkets.com




TROP2 Antibody Market Report: Clinical Trials Pave the Way, Revolutionizing Cancer Treatment – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global TROP2 Antibody Market & Clinical Trials Insight 2029” report has been added to ResearchAndMarkets.com’s offering.

In what marks a significant leap forward in precision oncology, the TROP2 (trophoblast cell surface antigen 2) antibody market is witnessing an accelerated growth in clinical trials and therapeutic applications. Recent developments indicate a heightened focus on utilizing TROP2 as a pivotal target in cancer therapies, particularly for various epithelial cancers.

With Trodelvy (sacituzumab govitecan) being the first and only TROP2-targeted drug approved so far, a substantial market growth is observed following its authorization for different cancer treatments. The driving force behind this growth is the increasing demand for effective therapies to address unmet medical needs in second-line metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.

Clinical Trials Fuel the Anticipated Market Opportunity

These emerging therapies, predominantly antibody-drug conjugates (ADCs), are demonstrating the potential to revolutionize the treatment landscape by offering a more targeted and less toxic approach. Further advancements are noted with promising candidates like Datopotamab deruxtecan, currently under review by regulatory authorities, broadening the clinical scope for TROP2-targeted treatments in different solid cancers.

Innovations in Treatment Modalities and Competitive Landscape

The current research environment is marked by innovation in TROP2-based therapies. Pharmaceutical and biotechnology companies worldwide are exploring a variety of treatment strategies, encompassing RNA-based therapies and cell therapies that either modulate TROP2 expression or engage the immune system to target TROP2-expressing cancer cells. Competition is intensifying as these entities, including notable names in the industry, invest heavily in clinical trials that span various phases and indications. This robust competition not only fosters innovation but is also expected to accelerate the introduction of new therapy options for patients.

Global Reach and Strategic Development

China’s prominent role in TROP2 therapeutic research, followed by the United States, highlights the capacity and resolve of the global biopharmaceutical sector to produce pioneering cancer treatments. This international effort ensures that innovative TROP2-targeted therapies could become accessible to patients worldwide in the near future. The commitment to enhancing cancer care is reflected in the consistent pursuit of strategic developments, such as identifying suitable biomarkers for patient selection, understanding resistance mechanisms, and integrating extensive data on treatment efficacies, all aimed at furthering the integration of these novel therapies into standard cancer care protocols.

Outlook for TROP2-Targeted Therapies in Oncology

The TROP2 antibody market is shaping a new era in cancer treatment, emphasizing a precise and refined approach to managing various epithelial cancers. As evidence from clinical applications and ongoing studies continues to mount, the value and scalability of these targeted therapies will become more apparent, potentially offering hope and improved outcomes for patients with limited treatment options. These advancements in precision oncology hold the promise of fortifying the position of TROP2-targeted therapies in cancer care, ensuring that they play a key role in shaping the future of effective and patient-centered treatment strategies.

A selection of companies mentioned in this report includes, but is not limited to:

• Abion Bio
• Amunix
• Aptamer Sciences
• Arbele
• Aston Science
• AstraZeneca
• Beijing Biocytogen
• BiOneCure Therapeutics
• Biosion
• Bio-Thera Solutions
• Daiichi Sankyo Company
• Hangzhou DAC Biotech
• Innovent Biologics
• Janux Therapeutics
• LegoChem Biosciences
• Merck
• Molecular Templates
• OBI Pharma
• Peak Bio
• Radiopharm Theranostics
• Shanghai Henlius Biotech
• Suzhou GeneQuantum Healthcare

For more information about this report visit https://www.researchandmarkets.com/r/2ulf2k

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

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FMCO Acquires Varcode, Inc., Paving the Way for Rapid Growth and Innovation




FMCO Acquires Varcode, Inc., Paving the Way for Rapid Growth and Innovation

NEW YORK–(BUSINESS WIRE)–#ColdChain–Four M Commercial Operations (“FMCO”) is pleased to announce the acquisition of substantially all the assets of Varcode, Inc. The transaction, which closed Tuesday, February 18, 2025 will create positive synergy for all parties involved, and positions Varcode for significant and sustainable growth moving forward.

“Joining the FMCO family of businesses represents a major step forward in Varcode’s evolution,” said Dan Bergstein, Chairman of Varcode, Inc. “With access to FMCO’s resources, both financial and otherwise, there will be little standing in the way of Varcode solidifying and enhancing its position as a leader in the markets we serve.”

“We could not be more excited to welcome Varcode into our portfolio,” Dennis D. Mehiel, CEO of Four M Commercial Operations said. “Varcode’s technology and product offerings are best in class, and we fully expect to grow the business dramatically and rapidly.”

Varcode is a leading provider of temperature-sensitive supply chain monitoring solutions. From food and beverage to pharmaceuticals, Varcode’s technology helps companies reduce waste, enhance safety, and protect their brands.

Four M Commercial Operations is a family-run private equity shop based in New York. The Company, along with its affiliates and predecessors, has been in operation for nearly 60 years and has a track record of consistent success across a variety of different verticals in both the consumer and industrial products spaces.

Contacts

Please direct inquiries to Amy Federman at 630-485-8469 or amy@varcode.com

PENMENVY, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY




PENMENVY, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY

• Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y)
• Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults

PHILADELPHIA–(BUSINESS WIRE)–#Adolescents–GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).^1,2

The vaccine combines the antigenic components of GSK’s two well-established meningococcal vaccines, BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine). The regulatory application was supported by positive results from two phase III trials [NCT04502693; NCT04707391], which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.^3-5

Tony Wood, Chief Scientific Officer, GSK, said: “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B. Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”

Integrating GSK’s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more US adolescents against these five common disease-causing serogroups – A, B, C, W, and Y – for which the US Centers for Disease Control and Prevention (CDC) have issued recommendations.⁶ Although MenB is the leading cause of IMD among this population, less than 13% receive the recommended two-dose vaccination series; around 32% receive at least one dose.^7,8 Three of every four MenB doses currently administered in the US are manufactured by GSK,⁹ positioning the company well to lead in the US market as MenB-containing vaccinations must be completed with the same manufacturer’s MenB vaccine.

Judy Klein, President and Founder of Unity Consortium, a non-profit organization focused on adolescent health and immunization in the US, said: “The consequences of IMD can be devastating for those who contract it, for their families and friends. We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”

At its meeting on February 26, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations for the appropriate use of GSK’s MenABCWY vaccine in adolescents and young adults.

About IMD

IMD is an uncommon but serious illness that can lead to death for up to one in six of those who contract it in as little as 24 hours from onset, despite treatment.^10,11 IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.^11,12 Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.^10,12 Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.^13,14

About PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine)

GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). It is indicated in the US for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. It is approved in the US for use in individuals aged 10 through 25 years. The US Prescribing Information is available here.¹⁵

Important Safety Information for PENMENVY in the US

The following is based on the US Prescribing Information for PENMENVY. Please consult the full Prescribing Information for additional safety information.

• Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
• Syncope (fainting) has occurred in association with administration of PENMENVY
• PENMENVY may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains
• Immunocompromised persons, including those receiving immunosuppressive therapy, may have reduced immune responses to PENMENVY
• Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis, including disease caused by serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY
• Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of a U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENMENVY to persons with a history of GBS should take into account the expected benefits and potential risks
• The most commonly reported solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2: pain at the injection site, fatigue, headache, myalgia, nausea, erythema, and swelling. The most commonly reported solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2: pain at the injection site, headache, fatigue, myalgia, and nausea

About BEXSERO (Meningococcal Group B Vaccine)

GSK’s MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunization programs worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. More than 110 million doses have been distributed worldwide since 2015.¹⁶ It is supported by clinical data supporting its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterized safety profile. In the US, this vaccine has received regulatory approval for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B and is approved for use in individuals aged 10 through 25 years. The US Prescribing Information is available here.¹⁷

Important Safety Information for BEXSERO in the US

The following is based on the US Prescribing Information for BEXSERO. Please consult the full Prescribing Information for additional safety information.

• Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO
• The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions
• Syncope (fainting) can occur in association with administration of BEXSERO
• BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains
• Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even after being vaccinated with BEXSERO
• The most commonly reported solicited adverse reactions: pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling

About MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.¹⁸ It offers evidence of immunogenicity with a well-characterized safety profile. In the US, this vaccine has received regulatory approval for active immunization to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in individuals from 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here.¹⁹

Important Safety Information for MENVEO in the US

The following is based on the US Prescribing Information for MENVEO. Please consult the full Prescribing Information for additional safety information

• Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
• Syncope (fainting) has occurred in association with administration of MENVEO
• Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even after being vaccinated with MENVEO
• Guillain-Barré syndrome has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine
• Apnea following intramuscular vaccination has been observed in some infants born prematurely
• Common solicited adverse reactions: at 2 months of age – tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age – tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age – injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Among adolescents and adults aged 11 through 55 years were pain at the injection site, headache, myalgia, malaise, and nausea – similar rates were observed following a booster dose
• In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation
• Vaccination with MENVEO may not result in protection in all vaccine recipients

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q4 Results for 2024.

Registered in England & Wales:

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Registered Office:

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WC1A 1DG

References:

1. Centers for Disease Control and Prevention. About Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/about/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmeningococcal%2Fabout%2Fcauses-transmission.html. Accessed February 2025.
2. European Centers for Disease Control and Prevention. Factsheet about meningococcal disease. Available at: https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet. Accessed February 2025.
3. GSK. GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/. Accessed February 2025.
4. NIH. Effectiveness of GlaxoSmithKline Biologicals S.A.’s Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults, ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04502693. Accessed February 2025.
5. NIH. Immunogenicity and Safety Study of GSK’s MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine, ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT04707391. Accessed February 2025.
6. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html. Accessed February 2025.
7. Cheng WY, et al. Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations. Hum Vaccin Immunother. 2020;16(1):176-188.
8. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023. Available at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388). Accessed February 2025.
9. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved.
10. World Health Organisation. Meningitis fact sheet. Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis. Accessed April 2024.
11. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
12. Marshall GS, et al. Understanding the Sequelae of Invasive Meningococcal Disease in the United States. Infect Dis Ther. 2024;13(11):2213-2220.
13. European Centers for Disease Control and Prevention. Outbreak of invasive meningococcal disease in the EU associated with a mass gathering event, the 23rd World Scout Jamboree, in Japan. 21 August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf. Accessed February 2025.
14. Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/risk-factors/index.html. Accessed February 2025.
15. GSK. US Prescribing Information for Penmenvy. Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF. Accessed February 2025.
16. GSK Data on File. Number of Bexsero doses shipped from 2015 to November 2023 REF-219766
17. GSK. US Prescribing Information for Bexsero. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF. Accessed February 2025.
18. GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022 REF-195452
19. GSK. Prescribing Information for Menveo. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF. Accessed February 2025.

Contacts

GSK enquiries
Media:

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Investor Relations:

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LimmaTech Vaccinates First Participants in Phase 1 Study of Staphylococcus aureus Vaccine Candidate LBT-SA7




LimmaTech Vaccinates First Participants in Phase 1 Study of Staphylococcus aureus Vaccine Candidate LBT-SA7

• CARB-X awards LimmaTech US$6.5 million to advance clinical development of LBT-SA7

ZURICH–(BUSINESS WIRE)–LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participants have been vaccinated in a Phase 1 controlled study of its multivalent vaccine candidate, LBT-SA7. The candidate is designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus (S. aureus). In this context, the company also announced the award of US$6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to advance the clinical development of LBT-SA7.

S. aureus infections pose a significant global health challenge, causing an estimated 1 million deaths annually. Notably, 90% of all community-acquired S. aureus infections are SSTIs. The absence of a vaccine to prevent S. aureus, coupled with only limited treatment options – particularly against multidrug-resistant strains of the pathogen, often described as methicillin-resistant S. aureus (MRSA) – highlights the urgent need for effective preventive solutions. LimmaTech’s vaccine candidate, LBT-SA7, is the first multivalent vaccine entirely based on secreted antigens to address this critical need. LBT-SA7 contains weakened forms of the pathogen’s toxins, referred to as toxoids, designed to prevent infections by neutralizing the toxins secreted by S. aureus. This approach offers a promising solution to combat the widespread bacterial threat.

LimmaTech started a Phase 1 clinical trial (NCT06719219) in the U.S. after receiving a Fast Track designation from the U.S. Food and Drug Administration (FDA). This first-in-human study aims to evaluate the safety and immunogenicity of LBT-SA7 against S. aureus. It is a randomized, double-blinded, and controlled dose-escalation study expected to enroll 130 healthy adults aged 18-50 years. Initial results are anticipated in the second half of 2025.

“Developing an S. aureus vaccine has long been a significant scientific challenge,” explained Dr. Patricia Martin-Killias, Chief Operating Officer of LimmaTech. “We believe LBT-SA7 has the potential to provide a much-needed solution for those suffering from S. aureus infections. We are excited to launch the first-in-human clinical trial for LBT-SA7, bringing us closer to addressing an urgent global health challenge.”

“We are grateful for the significant support from CARB-X, which is not only instrumental in accelerating the clinical development of our S. aureus vaccine candidate LBT-SA7 but also underscores the importance of our mission to develop efficient solutions for preventing microbial infections and protecting from their threatening consequences for affected people,” added Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech.

Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

About Staphylococcus aureus

Staphylococcus aureus (S. aureus), a Gram-positive bacterial pathogen, affects approximately 30% of the human population while causing a spectrum of infections, from SSTI to severe conditions like pneumonia and bloodstream infections. S. aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community-acquired and hospital-acquired infections being the most prevalent. SSTIs caused by S. aureus range from mild to severe and entail microbial invasion into the skin layers and underlying soft tissues. Traditional antibiotic treatments, both oral therapy and intravenous administration reserved for severe cases, have become increasingly less effective due to the rise of antibiotic resistance. S. aureus has been designated as a “high priority” pathogen by the World Health Organization (WHO), underscoring the urgency for innovative vaccine approaches and effective treatment strategies.

About LimmaTech Biologics AG

LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. For more information, please visit www.lmtbio.com.

Contacts

LimmaTech Biologics AG
Franz-Werner Haas, CEO

E-Mail: media@lmtbio.com

For media enquiries
Jacob Verghese or Anja Heuer

Trophic Communications

Phone: +49 151 7441 6179

Email: limmatech@trophic.eu

New ‘Super Test’ for Prostate Cancer Developed in the UK by EDX Medical




New ‘Super Test’ for Prostate Cancer Developed in the UK by EDX Medical

CAMBRIDGE, England–(BUSINESS WIRE)–#EDXMedical–Scientists in Cambridge have developed a new ‘super test’ for prostate cancer in an effort to revolutionise screening and diagnosis of the disease and accelerate personalised treatment for patients.

The test identifies the presence or absence of cancerous cells, signs of early and late-stage cancer, whether it is slow or aggressive as well as genetic and hereditary risks in the patient.

The new test involves studying the most comprehensive combination of clinically-validated prostate-related biomarkers currently known, in both blood and urine samples. The interpretation of these biomarkers using a proprietary AI-driven algorithm highlights early signs of cancer and characteristic features that can guide treatment selection.

There are 55,000 new cases of prostate cancer in the UK each year, more than 330,000 across European Union countries and more than one million men undergoing treatment at any one time.

More than 100 clinically validated biomarkers are measured in the new test – which has been developed by EDX Medical Group plc. The biomarkers used in the test are then analysed by the specially created AI-powered algorithm which produces a detailed report of results for doctors. Currently available advanced tests which rely on up to 20 biomarkers per test.

EDX Medical scientists expect the test to consistently deliver exceptionally high accuracy with levels of sensitivity and specificity of between 96-99% across an extended age-range and diverse ethnic groups. By comparison, current standard of care prostate testing, including prostate specific antigen (PSA) tests and biopsies, can be below 50%.

The non-invasive ‘super test’ will detect various sub-types of prostate cancer determining key features particularly important for patients in non-caucasian higher risk groups.

The super test takes a ‘multi-omics’ approach and comprises a combination of multiple proteomic, transcriptomic, genetic/hereditary and epigenetic biomarker signatures which provide detailed biological data. A comprehensive list of phenotypic and symptom data is added to the biomarker data and is simultaneously analysed by the AI algorithm.

Individually, these biomarkers have all been clinically validated and published and in previous trials on more than 31,000 positive prostate cancer samples as well as more than 100,000 control non-cancer samples.

A highly accurate prostate cancer test will provide significant benefits for seemingly well 45-70 year-old men and also for healthcare providers. The increased accuracy should reduce the requirement to run unnecessary MRI scans. The need for highly invasive digital rectal examinations (DRE) will also be dramatically reduced.

The new test is being developed at the Cambridge laboratory of EDX Medical Group which develops and supplies digitally enhanced diagnostic tools for cancer, cardiovascular and infectious diseases. The company has filed a patent application for the test and the AI algorithm with the European Patent Office.

Prof Sir Chris Evans, founder and chief scientific officer of EDX Medical, said: “We have been studying this area intensively and are tremendously excited by what we believe is a truly game-changing test. Every indication thus far shows it will be the most accurate and sensitive screening test available and will be transformative in tackling prostate cancer in men who may have no idea if anything is wrong with them.

“Our integrated approach highlights the potential of combining these molecular signatures, offering a powerful, non-invasive diagnostic tool that can certainly improve clinical outcomes and help personalise treatment for patients. The incorporation of all these biomarkers into routine screening could revolutionise prostate cancer management by enabling earlier detection and more accurate risk prediction. What sets this test apart is the use of so many biomarkers with best-in-class instrument and reagent technology and our bespoke AI algorithm.”

Sir Chris Hoy, who has been diagnosed with prostate cancer and supports campaigns to raise awareness and encourage early diagnosis, said: “Prof Sir Chris Evans and his team encouraged and supported me greatly after my initial diagnosis and I know they have some amazing people and a great commitment to finding better ways to diagnose and treat prostate and other cancers. I now know there is a need for better and more accurate prostate cancer screening tests and I wholeheartedly welcome this initiative by Sir Chris’ EDX.”

Rio Ferdinand, former Manchester United and England captain, whose mother and first wife Rebecca died of cancer, said: “Those of us who have lost a loved one to cancer and have campaigned for research and more awareness know full well the need for better and earlier testing across a range of cancers. Ethnic minority men not only have twice the risk of getting prostate cancer, they also have higher rates of stage 3 and 4 and more aggressive cancer. We know if it can be caught early these men can be mostly cured, but it’s not, and too many men are dying unnecessarily. I believe a test as good as Sir Chris’ EDX one can one day put a stop to this and I look forward to its launch later this year.”

Andy Taylor, guitarist with Duran Duran who was diagnosed with prostate cancer at 55, said: “Prof Sir Chris helped me immensely with my cancer treatment and this revolutionary new test from his labs is simply brilliant. To know your prostate cancer status, stage and type and all your genetics when you were unaware there was a problem at all is a life saver and game-changer. It is so accurate and comprehensive, it can spot many early prostate cancers, save many lives and save a fortune in fruitless treatments: this is priceless.”

Dr Mike Hudson, chief executive of EDX Medical said: “I’m confident that the EDX testing strategy will define a new standard for the early detection and characterisation of emergent, prostate cancer, and provide unique insights to guide optimal treatment selection.”

EDX Medical’s scientific team will validate further clinical data over coming months prior to seeking regulatory approval from the Medicines & Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) with a view to launching the test later this year or early 2026.

NOTES TO EDITORS

About multi-omics:

Multi-omics’ combines genomic, transcriptomic and proteomic analyses plus information on additional gene expression products and clinical data to provide significantly enhanced information which can guide clinical decision-making.

About PSA testing

The vast majority of men rely on PSA tests as their first assessment of prostate cancer but elevated PSA is regarded as unreliable for definitive cancer diagnosis. Research has shown that ~70% of men with elevated PSA levels do not have cancer at all whereas around 20% of men who show normal or low PSA levels do have cancer – and often an aggressive sub-type which is only discovered later when limited time remains for effective treatment..

About EDX Medical Group plc

The EDX Medical Group plc is listed on the Apex Segment of the AQSE Growth Market (TIDM: EDX). EDX Medical was founded by Professor Sir Christopher Evans, OBE, a medical and life sciences entrepreneur with more than 30 years of experience, together with CEO, Dr Mike Hudson.

By translating clinical insights into pragmatic solutions combining advanced biological and digital technologies, EDX Medical seeks to cost effectively improve the detection and characterisation of disease in order to personalise treatment in a timely fashion. Early disease detection and biologically-based personal treatment optimisation is considered to be the most impactful way of reducing deaths and lowering the cost of healthcare globally.

EDX Medical Group provides doctors, hospitals and insurers/payers with access to a portfolio of the best clinical diagnostics products and services. The Company operates its own facilities in Cambridge and Oxford, UK, and has a number of significant strategic with world leading companies and organisations in their respective fields.

www.edxmedical.com

Contacts

EDX Medical Group Plc
Dr Mike Hudson (Chief Executive Officer)

+44 (0)7812 345 301

Oberon Capital
Nick Lovering (Corporate Adviser)

Adam Pollock (Corporate Broking)

Mike Seabrook (Corporate Broking)

+44 (0)20 3179 5300

IFC Advisory (Investor Relations)

Tim Metcalfe

Graham Herring

+44 (0)20 3934 6630

Media House International

Ramsay Smith

+44 (0)7788 414856

ramsay@mediahouse.co.uk

Gary McQueen

+ 44 (0)7834 694609

gary@mediahouse.co.uk