VIVOLTA Partners with Neurochase to Manufacture Electrospun Micro-Catheters Delivering Advanced CNS Therapies to the Brain




VIVOLTA Partners with Neurochase to Manufacture Electrospun Micro-Catheters Delivering Advanced CNS Therapies to the Brain

• Long term manufacturing partnership – builds on previous product development partnership
• VIVOLTA to be exclusive electrospun component manufacturer to Neurochase
• Addresses growing neurological disorders market

WAALRE, Netherlands–(BUSINESS WIRE)–VIVOLTA, the medical electrospinning solutions provider, has signed a long-term partnership with Neurochase, the CNS (central nervous system) delivery platform specialist, to manufacture electrospun micro-catheters to deliver advanced therapies to the brain.

UK-based Neurochase is a medical technology company developing a scalable system to deliver therapies by Convection Enhanced Delivery (CED), directly to specific targets in the brain and CNS.

This technique allows drugs to get through the blood brain barrier to deep brain structures via micro-catheters; at the tip of the catheter a pressure gradient is generated and pushes the drug through the interstitial space allowing for homogenous distribution and maximising the therapeutic effect.

VIVOLTA first partnered with Neurochase in 2022 to jointly develop the electrospun component of Neurochase’s micro-catheter delivery system. VIVOLTA has worked as part of Neurochase’s R&D team, bringing a wealth of material science and application development expertise helping to achieve the breakthrough performance of the micro-catheter, and differentiating Neurochase’s product from other devices.

VIVOLTA will be Neurochase’s exclusive component manufacturer based on its unparalleled ability to manufacture electrospun medical products at scale using their fully-automated MediSpin™ production system.

Almost one billion people suffer from neurological disorders in the US and Europe alone, with the cost of care amounting to US$1.6 trillion per year. CED drug delivery is currently being used in clinical trials to treat a range of neurological conditions, including Parkinson’s Disease, Huntington’s Diseases, brain tumours and Fronto Temporal Dementia. Neurochase plans on entering clinical trials with its micro-catheter delivery system in collaboration with its clients in 2025.

Denis Leissing, CEO of VIVOLTA said:

“This partnership builds on our already successful product development work with Neurochase, establishing a long term manufacturing relationship. It is a great example of our full suite of electrospinning solutions from product development to commercial manufacturing. We’re proud that our team’s expertise along with our unique and scalable MediSpin™ manufacturing system will help bring this high-performance micro-catheter to patients who will benefit.”

Sharon Kane, CEO of Neurochase added:

“The VIVOLTA relationship has been hugely important in finding a solution to one of the most technically challenging components of the Neurochase delivery system. We are excited to be taking our transformative product forward together into large scale manufacture with such a knowledgeable, skilled and motivated team.”

About VIVOLTA

VIVOLTA is a fully integrated medical electrospinning solutions provider devoted to the development and high-volume manufacturing of electrospun medical products.

About Neurochase

Neurochase is developing the next generation of CNS delivery platforms, together with providing specialist services to pharmaceutical and biotech companies, enabling them to deliver gene and other therapies.

Contacts

VIVOLTA
Denis Leissing, CEO

+31 40 2827 956

Vigo Consulting (Media enquiries)
Rozi Morris

+44 20 7390 0230
vivolta@vigoconsulting.com

STEERLife and Callidus Research Laboratories Forge Strategic Partnership to Accelerate Innovative Drug Development




STEERLife and Callidus Research Laboratories Forge Strategic Partnership to Accelerate Innovative Drug Development

BENGALURU, India–(BUSINESS WIRE)–#CallidusResearchLaboratories–STEERLife, a pioneer in pharmaceutical development technologies, and Callidus Research Laboratories, a formulation development services company with a wealth of experience in comprehensive pharmaceutical drug development, have forged a strategic partnership to accelerate drug development for global markets. STEERLife is a division of STEER World.

The collaboration combines STEERLife‘s advanced Hot Melt Extrusion (HME) and Continuous Processing Technologies with Callidus’ Pharmaceutical Drug Development Expertise, addressing the global demand for innovative drug formulations and development.

By leveraging their combined strengths, STEERLife and Callidus will provide worldwide clients with advanced drug development services utilising Hot Melt Extrusion (HME) technology. This partnership enables both organisations to integrate their specialised knowledge and skills, yielding innovative solutions and enhanced product offerings. Additionally, the collaboration facilitates network, contact, and market reach sharing, allowing both companies to enter new regions and customer segments. Together, they will meet the global demand for next-generation pharmaceutical formulations, serving generic and brand companies.

This partnership also enables end-to-end drug development for highly potent APIs. Beyond their complementary capabilities, the organisations’ collaboration is fuelled by their shared commitment to pushing the boundaries of innovation to further futuristic product development for global markets.

“Our partnership with Callidus Research Laboratories represents a significant leap forward in pharmaceutical innovation,” said Indu Bhushan, CEO of STEERLife. “This collaboration empowers clients with cutting-edge technologies, extensive product development expertise, and seamless scale-up capabilities.”

“This development underscores STEERLife‘s commitment to excellence, innovation, and delivering exceptional value,” added Mr Bhushan.

“Partnering with STEERLife enhances our capabilities, allowing us to provide comprehensive, innovative solutions to pharmaceutical companies worldwide,” said Vardhaman Bafna, Co-founder & Director of Callidus Research Laboratories. “This collaboration exemplifies our dedication to pushing boundaries, fostering growth, and improving patient outcomes through transformative pharmaceutical solutions.”

About STEERLife

STEERLife, a division of STEER World, is a pioneering life sciences company that revolutionises pharmaceutical manufacturing and consumption through its cutting-edge, proprietary technology platforms. As India’s pioneering pharmaceutical company to transition from traditional batch processing to uninterrupted continuous processing, STEERLife delivers exceptional healthcare solutions, prioritizing quality, efficiency and patient-centricity, while fostering strategic partnerships and investments in innovative research and development.

About Callidus Research Laboratories

Callidus Research Laboratories is a formulation development services company founded and managed by a team of professionals from the pharmaceutical industry having excellent track record of serving worldwide markets.

The team at Callidus has proven capabilities in various dosage forms development and provides a full range of pharmaceutical drug product development services to customers across the globe.

We offer complete spectrum of services in the drug development program for our global partners consisting of formulation development, analytical development, stability studies, technology transfer, intellectual property rights and regulatory support.

Contacts

For More Information
Amit Jain, Myo Brand Partners, +91-9886062866

GenSight Biologics Announces Submission of LUMEVOQ® Dossier to ANSM to Prepare for Restart of Early Access Program in France




GenSight Biologics Announces Submission of LUMEVOQ® Dossier to ANSM to Prepare for Restart of Early Access Program in France

• Updated file will support medicines safety agency’s review of individual applications for early access (AAC) use
• First injections expected in December 2024

PARIS–(BUSINESS WIRE)–Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the submission of the updated regulatory file for LUMEVOQ^® gene therapy to the French medicines safety agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to prepare for the restart of the early access (AAC) program in France.

The submission documents the successful manufacture of LUMEVOQ^®, including the blending of two GMP drug substance batches to optimize the number of vials available for clinical use and the passing of all required quality control tests. LUMEVOQ^® is being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene, a rare mitochondrial genetic disease that causes acute and usually irreversible loss of vision.

“With the submission, we mark the successful transition from manufacturing to regulatory review,” commented Laurence Rodriguez, GenSight Biologics Chief Executive Officer. “We join the LHON community in looking forward to the expeditious resumption of early access to LUMEVOQ by year’s end.”

The updated regulatory file will support the ANSM’s assessment of individual applications for compassionate use, which can now be submitted by healthcare professionals under the rules of the AAC program. GenSight Biologics anticipates a review period for these applications and will work closely with the ANSM to optimize the assessment timeline.

GenSight Biologics is preparing to initiate the supply of the drug to the designated treatment center, the Quinze-Vingts hospital in Paris, in mid-December. In parallel, the Company is working with the hospital’s administrative and medical teams to enable the first injections to be administered by the end of December.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1^st eye, with the 2^nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously.

About LUMEVOQ^® (GS010; lenadogene nolparvovec)

LUMEVOQ^® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. “LUMEVOQ” was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018. LUMEVOQ® (GS010; lenadogene nolparvovec) has not been registered in any country at this stage.

Contacts

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

LifeSci Advisors
Investor Relations

Guillaume van Renterghem

gvanrenterghem@lifesciadvisors.com
+41 (0)76 735 01 31

Innate Pharma Reports Third Quarter 2024 Business Update and Financial Results




Innate Pharma Reports Third Quarter 2024 Business Update and Financial Results

• Jonathan Dickinson appointed Chief Executive Officer and Chairman of the Executive Board
• Encouraging initial FDA feedback received on lacutamab regulatory pathway
• Lacutamab health-related quality of life and translational data to be presented at the upcoming ASH Annual Meeting
• IPH4502, a Nectin-4 ADC received FDA clearance of the IND to be developed in solid tumors
• Preclinical data for proprietary tetra-specific NK cell engager IPH6501 and novel ADC IPH4502 presented at SITC
• Cash position of €96.4 million¹ as of September 30, 2024, anticipated cash runway to end of 2025
• Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced its business update and financial results for the first nine months of 2024.

“I’m honored to join Innate Pharma at such a pivotal moment in its evolution,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “We achieved notable regulatory milestones during the quarter including encouraging initial feedback from the FDA for lacutamab’s development plans and the IND approval for IPH4502, our nectin-4 ADC, which paves the way for its entry into clinical development. With presentations at ASH and SITC showcasing the depth of our translational science and patient-centered data, we are well-positioned to advance our mission of bringing transformative treatments to patients. Our cash position, with runway to the end of 2025, allows us to continue driving forward, and I am excited to lead the Company into its next phase of growth.”

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell Lymphoma

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides.

• During the financial quarter ending September 30, 2024, the FDA provided encouraging initial feedback on the Company’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, and the Company continues to align with the FDA around the confirmatory Phase 3 trial.
• Results from the study in Sézary syndrome and mycosis fungoides were presented at the American Society of Hematology (ASH) 2023 Annual Meeting and the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting respectively.
• Quality of life data and translational analysis from the TELLOMAK trial in patients with relapsed/refractory cutaneous T-cell lymphoma will be presented at the ASH Annual Meeting 2024.

Peripheral T Cell lymphoma (PTCL)

The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

ANKET^® (Antibody-based NK cell Engager Therapeutics):

ANKET^® is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes five drug candidates that have merged from the ANKET^® platform: SAR443579/IPH6101 (SAR’579; trifunctional anti-CD123 NKp46xCD16 NKCE), SAR445514/IPH6401 (SAR’514 trifunctional anti-BCMA NKp46xCD16 NKCE), IPH62 (anti-B7-H3), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (anti-CD20 with IL-2v). Several other undisclosed proprietary preclinical targets are being explored.

IPH6501 (proprietary)

IPH6501 is Innate’s proprietary tetra-specific second-generation ANKET^® targeting CD20 with an IL-2v. The Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL) is ongoing and enrolling patients.

• Preclinical data supporting the evaluation of IPH6501 in relapsed or refractory B-NHL subtypes and post-CAR-T therapy were presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting.

SAR’579/IPH6101, SAR’514/IPH6401, IPH62 and IPH67 (partnered with Sanofi)

SAR’579/IPH6101

The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR’579 / IPH6101, a trifunctional anti-CD123 NKp46xCD16 NK-cell engager and ANKET^® platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

SAR’514/IPH6401

The Sanofi led Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK-cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.

IPH62, IPH67 and option

• IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET^® platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
• During the third quarter of 2024, Sanofi terminated the IPH67 license during the research collaboration period. As a consequence, Innate plans to regain the full rights to IPH67, an NK-cell engager program in solid tumors from Innate’s ANKET^® platform. The rest of the 2022 research collaboration and license agreement remains unchanged.
• Sanofi still retains the option of one additional ANKET^® target under the terms of the 2022 research collaboration and license agreement.

Antibody Drug Conjugates:

Innate is leveraging its antibody engineering capabilities and is also exploring Antibody Drug Conjugates (ADC) formats.

IPH4502 (Nectin-4 ADC):

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.

• In September, the U.S Food and Drug Administration (FDA) cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications. Innate expects to initiate the Phase 1 study by Q1 2025.
  • The Phase 1, open-label, multi-center study, will include a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.
• Preclinical data of IPH4502 in Nectin-4 expressing tumors were presented at the SITC 2024 Annual Meeting.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

• The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. This follows the Independent Data Monitoring Committee recommendation for the continuation of the Phase 3 PACIFIC-9 trial based on a pre-planned analysis.

IPH5201 (anti-CD39), partnered with AstraZeneca:

• The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track. Following a pre-planned interim analysis, the MATISSE Phase 2 trial continues according to plans.

IPH5301 (anti-CD73):

• The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.

Corporate update

• The Supervisory Board appointed Jonathan Dickinson as the Company’s new Chief Executive Officer (CEO) and Chairman of the Executive Board, effective November 1, 2024. Jonathan Dickinson succeeds Hervé Brailly, co-founder of the Company, who was interim CEO, during the search process.

  Jonathan Dickinson most recently served as Executive Vice President and General Manager, Europe at Incyte, a role he held since 2016. Prior to Incyte, he gained significant leadership experience through several senior positions at ARIAD Pharmaceuticals, a US oncology focused biotechnology company and Bristol-Myers Squibb. This followed a distinguished 13-year tenure at Hoffmann-La Roche, where he was instrumental in driving the success of several of the company’s flagship oncology therapies. Mr. Dickinson began his career at Novartis, holding roles of increasing responsibility within the oncology and endocrinology divisions. He holds a Bachelor of Science degree in Genetics and a Master of Business Administration from the University of Nottingham.

• The ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares (“ADS”) is still in place. As of September 30, 2024, no sales have been made under the program.

Financial Results

Cash, cash equivalents and financial assets of the Company amounted to €96.4 million as of September 30, 2024. At the same date, financial liabilities amounted to €33.2 million.

Revenues for the first nine months of 2024 amounted to €10.2 million (€36.5 million for the same period in 2023). For the nine-month period, ended September 30, 2024, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC).

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, several ANKET^® drug candidates to address multiple tumor types as well as IPH4502 a differentiated ADC in development in solid tumors.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:
Investors
Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations
NewCap
Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

TetraScience Collaborates With NVIDIA to Industrialize the Production of Scientific AI Use Cases




TetraScience Collaborates With NVIDIA to Industrialize the Production of Scientific AI Use Cases

• The collaboration aims to accelerate the adoption of scientific AI in the life sciences by producing AI-enabled use cases at an industrial scale.
• The work combines the foundational elements of scientific AI: compute, AI-native scientific data, domain-specific models, and scientific use case expertise.
• TetraScience aims to deliver scientific and economic impact across the life sciences value chain powered by the Tetra Scientific Data and AI Cloud and NVIDIA BioNeMo platform.

BOSTON–(BUSINESS WIRE)–TetraScience today announced it is collaborating with NVIDIA to accelerate innovation in the $1.5 trillion life sciences industry by bringing standardization and scalability to the development and implementation of scientific AI.

The biopharma industry is racing to unlock AI’s potential across thousands of scientific use cases. However, millions of silos of proprietary and unstructured data and a project-based DIY approach block any ability to produce AI-ready datasets. Achieving success in scientific AI depends on eliminating silos and assembling the four essential components of a scientific AI stack: massive computational power, advanced models, sophisticated scientific ontologies, and deep scientific use case expertise.

TetraScience’s collaboration with NVIDIA makes such a reference scientific AI stack tangible for global drug companies looking to accelerate and optimize scientific workflows across the pharmaceutical value chain. The Tetra Scientific Data and AI Cloud provides a robust pathway to industrial-strength scientific AI through collaboratively optimized solutions with NVIDIA CUDA-X libraries, AI frameworks, and AI models. The Tetra Cloud is purpose-built to transform proprietary and unstructured scientific data into AI-native data and AI-enabled use cases. This solid and open data foundation will now tap into the value of NVIDIA’s accelerated computing infrastructure, domain-specific large language models, and deep learning capabilities.

“Scientific AI is the key to unlocking safer and more effective therapeutics as well as improving the economics of the life sciences industry,” said Patrick Grady, CEO of TetraScience. “By integrating TetraScience’s full-stack data, use case, and AI capabilities with the NVIDIA CUDA accelerated compute platform and domain-specific models, we intend to industrialize the production of AI-enabled use cases to help these vital organizations derive immediate scientific and business value.”

“One of the most significant ways AI can benefit the pharma and life sciences industry is by enhancing complex scientific experiments and lab data, reducing time and costs for managing them,” said Kimberly Powell, vice president of healthcare at NVIDIA. “We’re working with TetraScience to innovate and integrate generative AI and agentic workflows for knowledge extraction, relationship discovery, and reasoning, helping the industry get the most out of its data.”

TetraScience will work together with NVIDIA to engage with leading biopharmaceutical companies to establish a scientific AI use-case roadmap across drug discovery, development, manufacturing, and QC, prioritizing those with the highest impact. Lead clone selection, for example, is a critical but complex and time-consuming step in developing the cell lines that produce biologic drugs such as vaccines and monoclonal antibodies. Traditionally, it takes more than eight months to identify high-producing, stable clones. Models trained on AI-native Tetra Data could shrink that time by 80% by better predicting which are the “super clones.” TetraScience’s new Lead Clone Assistant data app uses the NVIDIA VISTA-2D model to analyze and classify hundreds of cellular images in minutes. It also applies the Geneformer model, accelerated and supported in the NVIDIA BioNeMo framework, to unearth gene expression differences between high-performing and problematic subpopulations, revealing details often missed in population-level studies.

About TetraScience

TetraScience is the Scientific Data and AI Cloud with a mission to radically improve and extend human life. TetraScience is accelerating the Scientific AI revolution by designing and industrializing AI-native scientific datasets, which it brings to life in a growing suite of next-generation scientific data and lab data automation products and AI-enabled scientific use cases. For more information, visit tetrascience.com or follow us on LinkedIn.

Contacts

Media inquiries: Bruce Upbin, pr@tetrascience.com

CORRECTING and REPLACING Mevion Delivers Wisconsin’s First Compact Proton Therapy System to the Froedtert & the Medical College of Wisconsin Clinical Cancer Center




CORRECTING and REPLACING Mevion Delivers Wisconsin’s First Compact Proton Therapy System to the Froedtert & the Medical College of Wisconsin Clinical Cancer Center

LITTLETON, Mass. & MILWAUKEE–(BUSINESS WIRE)–#MevionFIT–Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

MEVION DELIVERS WISCONSIN’S FIRST COMPACT PROTON THERAPY SYSTEM TO THE FROEDTERT & THE MEDICAL COLLEGE OF WISCONSIN CLINICAL CANCER CENTER

Mevion Medical Systems, a leading provider of proton therapy solutions, today announced the successful delivery of its MEVION S250i Proton Therapy System^® to the Froedtert & the Medical College of Wisconsin Clinical Cancer Center at Froedtert Hospital campus. This milestone marks a significant advancement in cancer care for adult and pediatric patients in Wisconsin, providing access to a highly targeted and effective treatment option.

First Compact Proton Therapy System in Wisconsin

Unlike traditional radiation therapy, proton therapy uses a unique characteristic of protons—their ability to deposit most of their energy at a specific depth—to target tumors with exceptional accuracy. The MEVION S250i is the first compact proton therapy system to be installed in Wisconsin, making the Froedtert & MCW Cancer Network a leader in providing this innovative technology to patients in the region.

Unique Elevated Treatment Room Installation

In another first, the MEVION S250i is installed in an elevated treatment room in a specially designed clinic. Its intentional design places it on the same level as the existing radiation oncology clinical space on the third floor of the cancer center. This innovative approach will streamline patient flow and enhance operational efficiency. The MEVION S250i is the most compact proton therapy system in the world, with all necessary equipment housed within a single room. This compact design allows for greater flexibility in installation, making proton therapy accessible to more hospitals and clinics.

Advanced Technology for Improved Patient Outcomes

The MEVION S250i is a compact and versatile proton therapy system designed to deliver precise radiation treatment to tumors while minimizing damage to healthy tissues. With its advanced technology and streamlined workflow, the system offers a range of benefits for patients, including reduced treatment time and improved quality of life.

“We are thrilled to partner with the Froedtert & the Medical College of Wisconsin Cancer Network to bring this cutting-edge technology to the region,” said Tina Yu, PhD, CEO and President at Mevion Medical Systems. “The MEVION S250i will provide patients with access to the most advanced cancer care available, and we look forward to seeing the positive impact it will have on the community.”

“Proton therapy represents a significant advancement in cancer care, offering patients a highly precise and targeted treatment option,” said Christopher Schultz, MD, FACR, radiation oncologist with the Froedtert & the Medical College of Wisconsin Cancer Network; professor and chairman of the Department of Radiation Oncology with the Medical College of Wisconsin. “By delivering radiation directly to the tumor while minimizing damage to surrounding healthy tissue, we can improve outcomes, reduce side effects and enhance the overall quality of life for our patients.”

About Mevion Medical Systems

Mevion Medical Systems is the leading provider of compact proton therapy systems for cancer care. Dedicated to advancing the design and accessibility of proton therapy worldwide, Mevion pioneered the single-room platform and continues to further the science and application of proton therapy. Since 2013, Mevion compact proton therapy single-room systems have been used by leading cancer centers for treating patients. Mevion’s series of products, including the flagship MEVION S250i and MEVION S250-FIT* with HYPERSCAN pencil beam scanning, represent the world’s most compact proton therapy systems that eliminate the obstacles of size, complexity, and cost. Mevion is headquartered in Littleton, Massachusetts with a presence in Europe and Asia. For more information, please visit www.mevion.com.

About the Froedtert & the Medical College of Wisconsin health network

The Froedtert & the Medical College of Wisconsin regional health network is a partnership between Froedtert Health and the Medical College of Wisconsin, supporting a shared mission of patient care, innovation, medical research and education. Our health network operates eastern Wisconsin’s only academic medical center and adult Level I Trauma Center at Froedtert Hospital, Milwaukee, an internationally recognized training and research center engaged in thousands of clinical trials and studies. The Froedtert & MCW health network, which includes 10 hospital locations, more than 2,300 physicians and more than 45 health centers and clinics, draws patients from throughout the Midwest and the nation. In our most recent fiscal year, outpatient visits totaled more than 1.6 million, inpatient admissions to our hospitals exceeded 57,500 and visits to our network physicians totaled more than 1.28 million. In 2024, Froedtert Health and ThedaCare became one organization, making it possible for the health network to enhance access to care for more people in Wisconsin. Learn more about the Froedtert & MCW health network.

*The MEVION S250-FIT Proton Therapy System is not yet available for clinical use.

Contacts

Media:
Jacqueline Abner-Pongratz

Mevion Medical Systems

Jacqueline.Pongratz@mevion.com

Oranda Therapeutics Announces Series A Funding Round to support its mission: to improve the lives of patients living with rare disease




Oranda Therapeutics Announces Series A Funding Round to support its mission: to improve the lives of patients living with rare disease

DUBLIN–(BUSINESS WIRE)–Oranda Therapeutics, a new Irish headquartered rare disease company with an innovative, fast to market, commercial approach, today announces the launch of their Series A Funding round to coincide with a period of exclusivity to finalise a licensing agreement for EMEA commercialisation rights for a novel medicine undergoing evaluation for treatment of hyperphagia in patients with Prader-Willi syndrome (PWS) with potential peak sales of over €100m.

The Company has entered into exclusive negotiations for a novel medicine, currently being evaluated in a Phase 2b study for the treatment of hyperphagia Prader-Willi syndrome (PWS). Subject to study outcome, this medicine is scheduled to commence a pivotal Phase 3 study in 2025.

Additionally, the Company has secured a portfolio of established rare disease medicines for commercialisation with the first launch planned for H1 2026.

Commenting on the announcement, Oranda Co-founder and CEO, Ahmed Al-Derzi, said: “We see an opportunity to improve the lives of those living with rare diseases, by expanding access to both established and novel rare disease medicines. Our shareholders will benefit from our team’s agility and vast experience in commercial excellence. We aim to be the partner of choice for BioPharma organisations with rare disease medicines, with our core mission of improving the lived experience of patients and their families.”

John Irwin, Oranda’s Co-founder and CCO, added: “We have seen a huge increase in products approved to treat orphan diseases over the last 20 years. Yet research shows, that only 37 per cent of these medicines are widely available throughout Europe. Our aim at Oranda Therapeutics, is to expand patient access to these established rare disease medicines, whilst simultaneously investing in the development and commercialisation of novel rare disease medicines in areas where we have domain expertise.”

Oranda is seeking funds for asset acquisition and the scale-up of its European commercial operations. Investors can benefit from timely exposure to the European rare disease market, a highly experienced leadership team, a portfolio of near-term commercial opportunities and a lead pipeline asset.

https://www.orandatherapeutics.com/

About the Founders

The leadership team at Oranda have led more than 20 successful European rare disease medicine launches. Ahmed Al-Derzi, CEO, is an experienced entrepreneur and business developer with more than 25 years in the industry. Previously, as Group CEO of Consilient Health, he was responsible for taking the business from a start-up to 100 employees, €70m in revenues and a presence in eight markets. John Irwin, CCO, brings more than 20 years’ experience in commercialising high-value orphan medicines in Europe and beyond, combined with a track record of developing and delivering initiatives to secure patient access for rare disease medicines.

About Prader-Willi syndrome

Prader-Willi syndrome (PWS) is a rare, complex genetic disorder that affects both males and females from birth and throughout their lives. It causes a wide range of physical symptoms, mild to moderate learning difficulty, and emotional and social immaturity, which can lead to challenging behaviours.

PWS is characterised by an overwhelming and insatiable chronic hunger (hyperphagia) which, without rigorous food management and exercise regimes, leads to incessant food seeking and life-threatening obesity. PWS occurs randomly in about 1:22,000 births in Europe. There are currently no approved therapies for the treatment of hyperphagia or behavioural aspects of the disorder.

Contacts

For more information on Oranda, please contact: info@orandatherapeutics.com

For media enquiries, please contact Richard Oakley at Oxygen Health Communications – richard@oxygenmediacomms.com

VarmX Announces Appointment of John Glasspool as CEO




VarmX Announces Appointment of John Glasspool as CEO

Leadership team fully strengthened to drive next phase of development

LEIDEN, Netherlands–(BUSINESS WIRE)–VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has appointed international life sciences industry veteran John Glasspool as CEO, with immediate effect.

John joins VarmX from the position of CEO at Anthos Therapeutics, a clinical-stage biopharmaceutical company developing therapies for high-risk cardiovascular patients, including FXI inhibitors, so is very familiar with the therapeutic space in which VarmX is developing lead asset VMX-C001. During John’s tenure as CEO, Anthos achieved successful fundraises with key sector investors, completed two Phase II studies and embarked upon two Phase III programs.

John has over 30 years’ experience within the global biopharma industry, linking science and business. His expertise includes building and growing companies, fundraising and investing, licensing, partnering and commercialisation.

Prior to Anthos, John held senior positions at large pharma organisations such as J&J, Novartis and Baxter. More recently, he has held consulting, advisory and investment partner roles with organisations including BIO, MIT, Roivant Sciences and Agent Capital.

John holds a degree in Politics and International Relations from Staffordshire University, a postgraduate in Clinical Pharmacology, Development and Regulation from Tufts University and a Diploma in Business Administration from Oxford Brookes University.

Dr. Jan Öhrström, Chairman of VarmX, said:

“John brings a wealth of international biopharma experience to the team. His direct knowledge of the coagulation and urgent care therapeutics space will be invaluable as we take VMX-C001 forward. VarmX’s leadership team is now significantly strengthened to enable us to drive the next stage of our growth with a Series C fundraise and a pivotal clinical trial.”

John Glasspool, CEO of VarmX, said:

“I am pleased to be joining the team at VarmX at such an exciting time for the business. This is a great opportunity to help develop and commercialise treatments for the rapid restoration of hemostasis, for the benefit of patients, clinicians and healthcare systems around the world.”

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter.

Contacts

Vigo Consulting (media enquiries)
Rozi Morris

+44 20 7390 0230

VarmX@vigoconsulting.com

Apollo Therapeutics Signs Exclusive Ex-China License From Sunshine Lake Pharma for Clinical-Stage FGF21 / GLP-1 Dual Receptor Agonist, a Therapeutic With Major Commercial Potential in Multiple Indications




Apollo Therapeutics Signs Exclusive Ex-China License From Sunshine Lake Pharma for Clinical-Stage FGF21 / GLP-1 Dual Receptor Agonist, a Therapeutic With Major Commercial Potential in Multiple Indications

• APL-18881 (HEC88473) is the most clinically advanced FGF21 / GLP-1 dual receptor agonist in development globally, currently in a Phase 2 study in patients with type 2 diabetes
• Both FGF21 and GLP-1 are clinically validated targets for cardio-metabolic disorders, liver disease, and related indications
• Dual agonist approach has potential to deliver enhanced efficacy in a range of conditions through complementary mechanisms
• Sunshine Lake is to receive $12m upfront and up to $926m in development, regulatory and commercial milestone payments. The commercial milestone payments are contingent upon reaching defined annual sales thresholds across major markets. In addition, Sunshine Lake stands to receive tiered royalties ranging from high single to low double digits on net sales.

CAMBRIDGE, England & DONGGUAN, China–(BUSINESS WIRE)–Apollo Therapeutics Group Limited (“Apollo”), the portfolio biopharmaceutical company, and Sunshine Lake Pharma Co., Ltd. (“Sunshine Lake”), an innovative pharmaceutical company and a member of HEC Group, one of the top 500 private business entities in China, have entered into an exclusive license agreement for the development of APL-18881 (HEC88473). Under the terms of the agreement, Sunshine Lake will retain development, manufacturing and commercialization rights in China and has granted Apollo development, manufacturing and commercialization rights in the rest of the world for all current and future therapeutic indications. Sunshine Lake is to receive $12m upfront and up to $926m in development, regulatory and commercial milestone payments. The commercial milestone payments are contingent upon reaching defined annual sales thresholds across major markets. In addition, Sunshine Lake stands to receive tiered royalties ranging from high single to low double digits on net sales.

Apollo is building a large and diversified pipeline of novel drug candidates and APL-18881 (HEC88473) will be its fifth program in clinical development. As well as discovering and developing new drugs based on breakthroughs in basic science made at its partner universities, Apollo also in-licenses or acquires clinical-stage assets based on strict selection criteria including the exploitation of unique insights and synergies arising from its discovery, human genetics, and other preclinical activities. APL-18881 (HEC88473) has an open US Investigational New Drug Application (IND) and Apollo will be clinically developing the molecule in a range of potential indications in the cardiometabolic, liver, and related disease areas that are not currently disclosed.

Sunshine Lake has long been dedicated to innovative drug development in anti-infection, oncology, and chronic metabolic disease areas, establishing a robust pipeline with multiple programs in mid-to-late clinical stages. While mainly focusing on domestic development and commercialization within China for novel drugs, Sunshine Lake is also actively exploring opportunities to expand into international markets. The collaboration with Apollo on the APL-18881 (HEC88473) program marks Sunshine Lake’s first international partnership for novel biologics, further emphasizing Sunshine’s commitment to global expansion efforts.

More about APL-18881 (HEC88473)

APL-18881 (HEC88473) is a bi-specific fusion protein developed by Sunshine Lake that agonizes FGF21 and GLP-1 receptors, both clinically validated targets, with several mono agonists in late-stage development or approved for a variety of indications.

APL-18881 (HEC88473) is currently in a double blind, placebo- and active agent-controlled Phase 2 trial in patients with type 2 diabetes in China (NCT06148649), where headline results are expected in H1 2025. There is also an open IND with the US Food and Drug Administration (FDA). The drug candidate has successfully completed Phase 1 trials (NCT05943886 and NCT04829123) in Australia and China in healthy and obese subjects, as well as type 2 diabetics. Data from these trials suggests APL-18881 (HEC88473) has an acceptable safety and tolerability profile and impressive pharmacodynamic responses at both the FGF21 and GLP-1 receptors at therapeutic doses. The clinical data was published last year at AASLD¹. Both parties are planning to continue or initiate clinical proof-of-concept studies during 2025.

“This transaction further delivers on our strategy to generate a large and diversified clinical portfolio of programs in major commercial indications with real unmet medical need,” said Dr. Richard Mason, Chief Executive Officer of Apollo Therapeutics. “The development of APL-18881 (HEC88473) completed by Sunshine Lake to date strongly suggests that this novel FGF21 and GLP-1 dual receptor agonist has clinical potential in multiple disease areas where these individual mechanisms have already been demonstrated to show robust clinical efficacy and where we anticipate synergies could occur between the two distinct mechanisms of action. We are excited to partner with the world-class team and exceptional R&D capabilities at Sunshine Lake who will develop APL-18881 (HEC88473) across a range of indications in China whilst we focus on development ex-China.”

“We are thrilled about this collaboration and are looking forward to working closely with Apollo on this exciting program,” said Dr. Zhang Yingjun, Chairman of the Board of Sunshine Lake Pharma. “HEC88473 is one of Sunshine Lake’s very first novel biologics programs, showcasing strong therapeutic potential with its differentiated mechanism of action. Apollo’s vision and clinical expertise will undoubtedly help accelerate the delivery of this novel treatment to patients.”

About Apollo Therapeutics Group Limited

Apollo Therapeutics is a portfolio biopharmaceutical company based in the UK and USA. Apollo translates breakthroughs in biology and basic medical research into innovative new medicines. With over 20 active therapeutic programs, five of which are in clinical development, the company is building a large, diversified portfolio of novel therapeutics with uncorrelated risk. Apollo has a scalable R&D platform enabled by an unprecedented level of access to breakthroughs in biology and basic medical research made at six of the world’s leading universities and research institutes. The company also in-licenses or acquires clinical-stage programs where it has unique insights and synergies. Backed by leading specialist health care investors, Apollo has raised a total of over $450m since its inception. Visit www.apollotx.com

About Sunshine Lake Pharma Limited

Sunshine Lake Pharma is a vertically integrated pharmaceutical company focused on the R&D, production, and commercialization of innovative drugs, and has a presence in the field modified new drugs, generic, and biosimilars. Since its founding in 2003, Sunshine Lake has built industry-leading R&D platforms, manufacturing facilities, and a global sales network. The company strategically targets infectious diseases, oncology, and chronic metabolic diseases, with products launched in China, the US, and Europe. Sunshine Lake Pharma’s mission is to provide innovative, high-quality, and affordable medications globally.

¹ Lin Xianga, Jiangyu Yanb, Lin Luob, Hong Zhanga, Can Xieb,c, Yuyu Pengb, Hong Chena, Qianqian Lia, Xiaoping Lib,c, Yulei Zhuangb, Linfeng Guob,c, Yanhua Dinga, 2023. Safety, Pharmacokinetics and Pharmacodynamics of a Novel GLP-1/FGF21 Dual Agonist HEC88473 in Type 2 Diabetes Patients with Nonalcoholic Fatty Liver Disease: a randomized, double-blind, placebo-controlled, Phase 1b/2a multiple-ascending-dose study.

Contacts

For media and investor inquiries

For Apollo Therapeutics

Apollo Therapeutics
Clare Burles, VP People & Communications

Clare.burles@apollotx.com

Apollo Therapeutics Media Inquiries
Ben Atwell / Simon Conway / Alex Davis – UK

Jim Polson / Matt Ventimiglia – US

FTI Consulting: ApolloTherapeutics@fticonsulting.com
+44 (0) 20 3727 1000 – UK +1 (212) 850 2654 – US

For Sunshine Lake
Lin Taoxi, VP, Board Secretary

LinTaoxi@hec.cn

Merck to Present New Data From GARDASIL®9 Studies Reinforcing the Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at the International Papillomavirus Conference (IPVC) 2024




Merck to Present New Data From GARDASIL®9 Studies Reinforcing the Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at the International Papillomavirus Conference (IPVC) 2024

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new clinical and real-world data for the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), evaluating the burden and incidence of certain HPV-related cancers and diseases, will be presented at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh, UK, from November 12-15.

Data to be presented include results from the BROADEN and PROGRESS studies evaluating the prevalence of oral HPV infection and burden of HPV-related oropharyngeal and other head and neck cancers, as well as studies evaluating the age of disease-causal HPV infection among females and highlighting the importance of protecting both females and males from HPV-related cancers and diseases through vaccination.

“These data support the value of adult vaccination and strengthen our understanding that disease-causal HPV infection can happen later in life, reinforcing the importance of HPV vaccination for both females and males beginning at age 9,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “While historically the HPV vaccination conversation has focused on preventing certain HPV-related cervical cancers in women, we also continue to see the growing incidence of HPV-related oropharyngeal and other head and neck cancers, particularly in men. In both men and women globally, there are approximately 666,000 new diagnoses of certain HPV-related cancers annually. The breadth of data we are presenting at the conference continues to demonstrate the link between HPV and certain HPV-related cancers in males and females and the role HPV vaccination can play in prevention.”

Details on key abstracts for Merck:

Indication for GARDASIL 9

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

– HPV types not covered by the vaccine

– HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients

Select Safety Information for GARDASIL 9

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established.

Dosage and Administration

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.

For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

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 on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

About Merck’s global commitment to supply and access to HPV vaccines

Merck is committed to ensuring adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases.

This commitment is enabled through significant capital investments, including more than $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand. As a result, we expect to supply sufficient quantities of our HPV vaccines to meet anticipated demand and will continue to expand supply capacity in the future.

Global equitable access to our HPV vaccines is a key part of our efforts and key partnerships help us achieve these goals. In 2024, Merck reaffirmed its commitment to Gavi, the Vaccine Alliance, through an agreement with UNICEF, to supply low- and middle-income countries with over 115 million doses of HPV vaccine by 2025, to appropriately support local immunization programs. Merck has consistently increased our supply commitment to Gavi from 1.7 million doses in 2017 to more than 30 million doses in 2024.

Additionally, we are working to ensure continued supply in countries with existing HPV vaccination programs and currently supply approximately 150 National Immunization Programs globally.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf

Contacts

Media Contacts:

Julie Cunningham

+1 (617) 519-6264

Muchena Zigomo

+1 (267) 309-5591

Investor Contacts:

Peter Dannenbaum

+1 (732) 594-1579

Damini Chokshi

+1 (732) 594-1577