AvenCell Therapeutics, Inc.

SAN CARLOS, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced it has appointed Dr. Olivier Brandicourt, a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A., to its Board of Directors. “We are thrilled to welcome Olivier to Vaxcyte’s Board of Directors,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “He brings a wealth of biopharmaceutical expertise, with significant experience in commercial strategy and execution within the global vaccine market. During his time as the CEO of Sanofi, he further bolstered the company’s standing as one of the world’s leading commercial vaccine companies. His strategic insight and operational leadership will be instrumental as we advance toward the potential global commercialization of our pneumococcal conjugate vaccine (PCV) candidates. Separately, I would like to extend our sincere thanks to Dr. Peter Hirth, who has served on the Board since 2016 and will conclude his tenure in June. We are deeply grateful for his years of dedicated service and myriad contributions to Vaxcyte during a defining period in our growth.” “Vaxcyte’s carrier-sparing platform represents a highly differentiated and scientifically compelling approach, with the potential to address some of the most pressing unmet needs in the prevention of bacterial diseases,” said Dr. Brandicourt. “I’m honored to join the Board at such a pivotal time and look forward to working with the team as the Company continues to advance its PCV candidates toward potential commercialization. By broadening protection against invasive pneumococcal disease, Vaxcyte is not only aiming to set a new standard of care—it is also contributing to the global effort to combat antimicrobial resistance, a pervasive public health threat driven by the overuse of antibiotics.” About Dr. BrandicourtDr. Brandicourt is a distinguished executive in the biopharmaceutical industry. He is currently a Senior Advisor at Blackstone Life Sciences and serves on the boards of Alnylam Pharmaceuticals, Inc., AvenCell Therapeutics, Inc., BeOne Medicines Ltd. and Dewpoint Therapeutics, Inc. He was the CEO of Sanofi S.A. from 2015 to 2019, where he was instrumental in advancing the company’s vaccine portfolio through the acquisition of Protein Sciences and its recombinant influenza vaccine, and the CEO of Bayer HealthCare AG from 2013 to 2015. Dr. Brandicourt also spent 13 years at Pfizer Inc., including as a member of the Executive Leadership Team and as President and General Manager of the Emerging Markets and Established Products business units. Additionally, he served in a series of leadership positions, including heading Pfizer’s Global Specialty and Global Primary Care business units. Dr. Brandicourt studied medicine in Paris where he specialized in Infectious Diseases and Tropical Medicine and holds a Master’s Degree in Biology and an Advanced Degree in Cellular and Immunological Pathophysiology. He is an Honorary Fellow of the Royal College of Physicians in London and has been a director of the National Committee on U.S.-China Relations since 2012. About Vaxcyte Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and PCV candidates; the potential global commercialization of its PCV candidates; the ability to improve upon the standard-of-care and combat antimicrobial resistance; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Yearly Report on Form 10-K filed with the SEC on February 25, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date. Contacts: Patrick Ryan, Executive Director, Corporate AffairsVaxcyte, Inc.415-606-5135media@vaxcyte.com Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte, Inc.860-729-8902investors@vaxcyte.com

Funding to accelerate clinical validation of AvenCell's proprietary Universal Switchable CAR-T cell therapy platform, for the treatment of a wide range of hematologic malignancies and auto-immune diseases New investors F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital and NYBC Ventures join Novo Holdings alongside founding investor Blackstone Life Sciences Michael Bauer of Novo Holdings and Nihal Sinha from F-Prime Capital to join AvenCell's Board of Directors WATERTOWN, Mass., Oct. 22, 2024 /PRNewswire/ -- AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, today announced that it has raised $112 million in Series B financing. The financing was led by global life sciences investor Novo Holdings. New investors F-Prime Capital, Eight Roads Ventures Japan, Piper Heartland Healthcare Capital and NYBC Ventures also participated in the round alongside founding investor Blackstone Life Sciences. As part of this financing, Michael Bauer, Ph.D., Partner, Venture Investments, Novo Holdings, and Nihal Sinha, MB BChir, Partner, F-Prime Capital will join AvenCell's Board of Directors. This latest financing will support ongoing clinical validation of AvenCell's proprietary, switchable universal CAR-T cell therapy platform that generates CAR-T cells that can rapidly be turned "Off" and "On" even after they are administered to a patient. The universal platform was developed to more safely and effectively treat a wide range of hematologic malignancies compared to conventional cell therapies. Current clinical assets utilizing AvenCell's universal platform include AVC-101, a highly-differentiated autologous CAR-T cell candidate, and AVC-201, a CRISPR-engineered allogeneic CAR-T cell candidate. Both products target the antigen CD123 found on most Acute Myeloid Leukemia (AML) cells. The ongoing trials are investigating both products for the treatment of relapsed/refractory AML, which has a high unmet medical need, and very limited treatment options for patients. In addition, AvenCell has several pipeline candidates entering the clinic over the next two years. "We are excited by the progress of our pipeline and believe our next-generation immunotherapies have the power to address significant unmet patient needs," said Andrew Schiermeier, Ph.D., Chief Executive Officer, AvenCell Therapeutics. "AvenCell is working to transform the standard of care through switchable, adaptable and readily available cell therapy treatments that can better treat a wide range of difficult-to-treat cancer and autoimmune diseases. The support of Novo Holdings and this leading group of new investors will be integral to our ability to progress and bring these therapies to patients." "AvenCell's universal switchable technology and CRISPR-engineered allogeneic platforms are first-of-its-kind and represent a step change in the field of cell therapy. Both AVC-101 and AVC-201 have already yielded encouraging safety and efficacy results in early clinical trials in a very difficult to treat disease like AML. Our investment reflects our confidence in these assets and the future of cell therapy, as well as our long-held strategy to support companies transforming care solutions to enhance patient outcomes," said Michael Bauer, Partner, Venture Investments, Novo Holdings. "AvenCell's switchable CAR-T platform represents a paradigm shift in cell therapy, offering unprecedented control over treatment dynamics," said Nihal Sinha, MB BChir, Partner at F-Prime Capital. "The ability to modulate CAR-T cell activity post-infusion could address critical safety and efficacy challenges in current therapies. We look forward to supporting AvenCell's journey in advancing these promising cell therapies through clinical development, with the potential to address significant unmet needs in the treatment landscape." About AvenCell Therapeutics AvenCell derives its name from the French word "avenir" to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and additional programs targeting other hematological malignancies. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. For more information, visit . Follow AvenCell on social media: LinkedIn. SOURCE AvenCell Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AVC-201 is the world's first CRISPR-engineered switchable allogeneic CAR-T designed to fully avoid rejection by both the innate and adaptive host immune system. WATERTOWN, MA, USA I February 6, 2024 I AvenCell Therapeutics, Inc . , a leading clinical-stage cell therapy company focused on advancing both autologous and allogeneic switchable CAR-T cell therapies, today announced that it has dosed the first patient in a Phase IA study with AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125). AVC-201 is a CRISPR-engineered allogeneic switchable CAR-T candidate designed to target and eliminate cells expressing receptor CD123, which is known to be overexpressed in nearly all acute myeloid leukemias, and several other hematological malignancies. "Patients with AML with minimal residual disease or who progress after currently available treatment approaches generally have a very poor prognosis and limited options," said Professor Martin Wermke, Head of the Early Clinical Trial Unit at the National Cancer Center Dresden, Germany. "AvenCell's autologous switchable CAR-T therapy has already yielded highly promising early clinical results in AML treatment. AVC-201, a readily available donor-derived allogeneic cell product is expected to reach the patients in need much faster at substantially lower cost." The phase 1 study, which includes up to 37 patients, will be conducted at multiple sites in Germany and the Netherlands.  The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence. "We are excited to build on the safety and promising activity observed in our ongoing autologous switchable clinical study in AML (AVC-101) by now implementing what we believe is the most scientifically-compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell's President & CEO.  "We are the first company to combine a Switchable CAR-T with an off-the-shelf solution for broad applications across cancer and autoimmune indications. This modular approach allows for unparalleled future flexibility and reduction in cycle times, massive scaling of supply, and meaningful reductions in cost of goods, all of which will dramatically advance the field of cell therapy for patients." About AVC-201 AVC-201 is a CRISPR-edited Chimeric Antigen Receptor ("CAR")-T Cell therapy that embodies two discrete technology platforms. The first leverages AvenCell's "UniCAR" universal/switchable technology which is comprised of a two-component system. Engineered T Cells are transduced with a "universal" receptor that is completely biologically inert (expressing human La peptide) and are only activated when bound to a second biologic molecule ("targeting module") which directs the T cells to a cancer antigen of interest (in this case, CD123).  The presence or absence of the targeting module in circulation allows for exquisite "on" and "off" control, respectively, of the therapeutic activity.  The second technology platform consists of an in-licensed allogeneic cell engineering technology developed by Intellia Therapeutics which allows for unrelated donors to provide cells for patients. These cells are uniquely engineered via CRISPR/Cas9 to avoid GvHD and rejection via the host/patient immune system by either innate or adaptive mechanisms. About AVC-201 Clinical Program AvenCell's Phase I study (NCT05949125) is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AVC-201 in adults with relapsed or refractory AML and other CD123 positive hematological malignancies. The study is an open-label, single-ascending dose design used to identify a cell and targeting module dose level combination of AVC-201 that will be further evaluated in a subsequent Phase 2 study. About Acute Myeloid Leukemia (AML) AML typically develops from mutations in the DNA of early blood-forming cells, leading to the disruption of normal cell maturation and proliferation. This results in a buildup of immature cells in the bone marrow, crowding out healthy cells and impairing their ability to function properly. AML accounts for a significant proportion of all leukemia cases. Approximately 21,000 new cases of AML are diagnosed in the United States per year, while on a global scale, the incidence of AML is estimated to be around 2-8 cases per 100,000 people annually.  Treatment for AML usually involves chemotherapy to destroy cancer cells, and more recently available targeted therapies directed against specific mutations (e.g.  IDH, FLT3.)  While most AML cells express the receptor CD123, several previous attempts to target this receptor therapeutically have failed due to the difficulty in managing toxicity. AVC-201 addresses this limitation by implementing a rapid on/off switch via dosing of targeting module. Stem cell transplant continues to be considered the only curative option.  The survival rate of AML can vary depending on several factors, including age, overall health, specific genetic mutations, response to treatment, and other individual characteristics.  However, the overall five-year survival rate for AML is around 25-30%. About AvenCell Therapeutics AvenCell derives its name from the French word "avenir" to reflect the aim to be the FUTURE of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and prostate cancer, and additional programs targeting other hematological malignancies and solid tumors. AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches. AvenCell Therapeutics, Inc. was launched in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics, and incorporated the clinical-stage biopharmaceutical company GEMoaB GmbH. AvenCell is headquartered in Watertown, Massachusetts with additional R&D and manufacturing operations in Dresden, Germany. AvenCell Europe GmbH is sponsor of the AVC-201 study. For more information, visit www.avencell.com . SOURCE: AvenCell Therapeutics