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FDA Grants Fast Track Designation to Aveta Biomics’ Drug APG-157 for Neoadjuvant Treatment of Head and Neck Cancer

August 22, 2024

BOSTON, MASSACHUSETTS, UNITED STATES, August 22, 2024 /EINPresswire.com/ — – Aveta Biomics, a pioneering oncology company developing first-in-class oral immuno-oncology drugs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to APG-157, its next-generation immuno-oncology drug, for the neoadjuvant treatment of Head and Neck Cancer (HNC). This

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robert charnas, phd

Robert Charnas, PhD

Robert Charnas, PhD is a pharmaceutical executive with over 20 years of global regulatory and strategic program leadership experience. He has a proven track record in successful product registrations for both small and large molecules across North America, Europe, and Asia. His expertise spans development from pre-IND through Phase IV studies, with a strong focus on oncology, infectious diseases, and experience in rare diseases. He most recently served as Worldwide Regulatory Affairs Transformation Lead and Head of US Regulatory Affairs at Servier Bio-Innovation, where he oversaw key regulatory successes, including the FDA approval of VORANIGO for IDH-mutant low-grade glioma and TIBSOVO for both 1L ICIE AML (in combination with azacitidine) and R/R MDS. Previously, Dr. Charnas was Vice President and Head of Global Regulatory Affairs at Agios Pharmaceuticals and Vice President of Strategic Program Direction for Oncology at Regeneron Pharmaceuticals.

He has also worked at top pharmaceutical companies, including Amgen, Novartis, and Hoffmann-La Roche, having had functions in regulatory affairs, clinical development, and medical strategy. A Harvard-trained Ph.D. chemist with prestigious fellowships and honors, including the Johnson Medal at J&J, Dr. Charnas is a multilingual leader adept at fostering innovation in drug development.

ajay gupta

Ajay Gupta

Ajay Gupta, Senior Partner Emeritus at McKinsey & Company, brings over 30 years of healthcare expertise spanning pharmaceuticals, biotech, medtech, health systems, academic centers, and a wide range of healthcare services, including PBMs, drug store chains, and health information technology. At McKinsey, he led the Midwest Healthcare and North America Medical Products practices, advising on strategy, growth, M&A, and innovation. Gupta serves on multiple boards: BJC Healthcare, Vizient Inc., OnPoint Surgical, Healthium Medtech, VIC Technology Venture Development. He is also an active investor focused on growth companies and innovation.

In addition to having served on the RAND Health Advisory Board and Innovaccer’s Strategic Advisory Council, Gupta has published extensively on healthcare strategy and commercial excellence. With an MBA from Stanford (Arjay Miller Scholar) and a B.Tech from IIT Delhi (President’s Gold Medal), his strategic insights and vast experience will be invaluable in advancing Aveta’s initiatives and accelerating its impact in cancer treatment.

Peter R. Dolan, Member of the Board of Directors

As the former CEO and Chairman of Bristol-Myers Squibb (BMS), Mr. Dolan has an impressive track record of leadership in the pharmaceutical industry. His 18 transformative years at BMS saw the addition of the blockbuster drug Eliquis to its portfolio, investment in ImClone’s Erbitux—a key treatment for solid tumors, including Head & Neck Cancer—and the licensing of the immuno-oncology drug Yervoy, crucial to BMS’s oncology business. He also oversaw substantial investments in biologics.

Currently, he serves as Chairman of the Board of Trustees at Tufts University and chairs the Partnership for A Healthier America. Post-BMS, Mr. Dolan led GeminX to a $225 million acquisition by Cephalon Pharmaceuticals. He also served on the Board of Directors of Amplitude Health Care, a Special Purpose Acquisition Company that merged with Jasper Therapeutics.

Mr. Dolan has served on various boards, including American Express and ChildObesity180. He holds a BA magna cum laude from Tufts University and an MBA from Dartmouth’s Tuck School of Business.

Daniel Hartl

Daniel L. Hartl, PhD, Scientific Advisor

Daniel is Higgins Professor of Biology and former Chair of the Department of Organismic and Evolutionary Biology at Harvard University. His laboratory studies genetics, genomics and molecular evolution. His seminal contributions to experimental evolutionary genetics have far-reaching impact on understanding the development of resistance to drugs in human diseases. An elected member of the National Academy of Sciences, USA, the American Academy of Arts and Sciences, and the National Academy of Sciences of India, Prof. Hartl has been honored with the Samuel Weiner Outstanding Scholar Award and the Medal of the Stazione Zoologica Anton Dohrn. He is a Past President of the Genetics Society of America and the Society for Molecular Biology and Evolution and has served on the National Institutes of Health Genetics Study Section, Genetic Basis of Disease Review Committee, and on the Editorial Boards of Genetics, Annual Review of Genetics and, Molecular Biology and Evolution. He has authored or coauthored more than 400 scientific articles and 20 books including Genetics: Analysis of Genes and Genomes, Essential Genetics: A Genomics Perspective, Principles of Population Genetics and Primer of Population Genetics.

Eugene I. Shakhnovich, PhD

Eugene I. Shakhnovich, PhD, Scientific Advisor

Eugene is a Professor of Chemistry and Chemical Biology at Harvard University.  He is one of the leading researchers in the areas of protein folding and has carried out crucial work tying the physical chemistry of protein with the evolutionary biology. His laboratory has made fundamental contributions to understanding of the mechanisms of drug resistance by studying the mutational fitness of an organismal evolution using the biophysical principles. He is the author of more than 200 publications, serves on the editorial boards of several major journals and is a recipient of several awards and fellowships. Prof. Shakhnovich is also an entrepreneur who co-founded Vitae Pharmaceuticals (NASDAQ:VTAE) which was recently acquired by Allergan for $639 million.

Bharat Tewarie

Bharat Tewaries, MD, MBA, Member of the Board of Directors

Bharat is a C-suite executive with deep strategic and operational expertise.  Trained as a medical doctor with an MBA, Dr. Tewarie held positions of increasing responsibilities at Boehringer Ingelheim, Roche, Merck Serono, and UCB in Europe and USA. His rich experience encompasses direct P&L responsibilities, executive management, business development, clinical development, medical affairs, sales & marketing including brand strategy, access & pricing.  Most recently, he was the Executive Vice President & Chief Marketing Officer and member of the Executive Committee of UCB.  Prior to that he served as Senior Vice President of different functional units at Merck Serono. Since  2021 he is the CEO and Chair of the Board of ViroCarb Inc and the founder of Boston Biopharma Consultants, a strategic advisory firm for biopharma and medical devices companies. Dr. Tewarie received his MD from Utrecht University , Utrecht, The Netherlands and MBA from Webster University, Leiden, The Netherlands.

David Page

David Page, Member of the Board of Directors

David brings to the Board broad business experience, as a finance professional and entrepreneur/operator, transcending many industries. Since 2012, David has served as the Chairman and Chief Executive Officer of Boston Harbor; a financial industry-leading asset management strategy platform. His track record of success spans the founding of two start-ups IDEAssociates and EnvoyWorldWide; two leveraged buyouts Alcatel Data Systems and Network Solutions, and the management and sale of Tribotek to Methode Electronics. His experience in building companies includes successful responsibilities for R&D, Sales & Marketing, Manufacturing, IT, corporate finance, and striking domestic and international relationships with major partners.  David holds a B.S. in Electrical Engineering from Cornell University and an M.B.A. from Harvard University.

S P Kothari

Prof. S. P. Kothari, Member of the Board of Directors

Professor Kothari is currently Gordon Y Billard Professor of Finance and Accounting and previously Deputy Dean of MIT Sloan School of Management. He has held senior executive experience in government, academia, and industry. Most recently, he served as Chief Economist  at the US Securities and Exchange Commission from 2019 to 2021. Previously, Dr. Kothari was global head of equity research for Barclays Global Investors (acquired by BlackRock). He has served as a director of Bombay Stock Exchange (BSE) and he Co-Chaired the Board of Governors of Asia School of Business, Kuala Lumpur. He currently he serves on the boards of Velan Studios and EbixCash. Prof. Kothari is a recipient of numerous awards for his scholarship, including India’s Padma Shri award in 2020, Honorary Doctorates from London Business School, University of Cyprus, and University of Technology, Sydney. Kothari received his BS in engineering from the Birla Institute of Technology & Science, MBA (PGDM) from the Indian Institute of Management, Ahmedabad, India and PhD from the University of Iowa.

Anastasia Tousimis

Anastasia Tousimis, MD, FACS, MBA

Dr. Anastasia Tousimis is the Director of the Scully Welsh Cancer Center at Cleveland Clinic Indian River Hospital. She previously served as Professor of Surgery and Director of the Breast Center at Georgetown University Hospital, where she also led the Division of Breast Surgery and the Clinical Research program. She completed her breast surgical oncology fellowship at Memorial Sloan Kettering Cancer Center and further specialization in minimally invasive surgery at the European Institute of Oncology in Milan, Italy.

Dr. Tousimis was an Associate Professor of Surgery at Weill Cornell Medical College, where she served for nearly ten years. She earned her MD from Albany Medical College and MBA from Sloan School of Management at MIT.  Recognized for her innovations in breast cancer management, she has published extensively and was the 99th President of the American Medical Women’s Association. In 2023, Georgetown University Hospital named an operating room in her honor.

martina molsbergen

Martina Molsbergen, Chief Business Officer

Ms. Molsbergen is a seasoned executive with over 30 years of strategic insight and deal-making prowess in the pharmaceutical industry. She has extensive experience in therapeutics, including cell and gene therapy, oncology, and botanical drugs, leading to numerous successful licensing and partnership transactions worth billions. Most recently, she served as Chief Business Officer for Pyxis Oncology. Prior to that, she held senior business development roles at companies including AbSci, Sorrento Therapeutics, Selexis SA, Oxford Biotherapeutics, Kyowa Hakko Kogyo, and Crucell Holland BV.

.She is the Founder and President of The C14 Foundation, a charity focused on sustainable solutions for the poorest communities, and serves on the board of BlueSky Surgical, a nonprofit providing free surgeries in Haiti. Ms. Molsbergen holds a B.S. in Chemical Engineering from Drexel University.

Karim Malek

Karim Malek, MD, MTh, MBA

Dr. Karim Malek is a quadruple-boarded medical oncologist and hematologist with over 30 years of clinical and research experience. Previously, he was the Vice President of Clinical Development at Ikena Oncology, the Global Clinical Lead spearheading the development of immuno-oncology drugs at Takeda, and served as Senior Medical Director at ImmunoGen, overseeing early and late-phase trials for novel cancer therapies.

 Before joining the industry, Dr. Malek was Chief of the Division of Hematology-Oncology at Good Samaritan Medical Center in the greater Boston area, pioneering community hospital participation in clinical research. He has authored over 40 peer-reviewed publications and held academic positions at Boston University and Tufts Schools of Medicine.

Dr. Malek is a graduate of the University of Alexandria, Faculté de Médecine Pierre-et-Marie-Curie, Faculté de Médecine Paris-Bobigny, Boston University School of Medicine and holds an executive MBA from the Sloan School of Management at MIT.

Luis Z Avila

Luis Z Avila, PhD

Luis brings to Aveta Biomics more than 20 years of industrial experience spanning early startup (Focal, Inc) through biotech (Genzyme) and most recently as Distinguished Scientific Fellow at a multinational pharmaceutical company (Sanofi). He has successfully guided several product concepts through various phases of discovery, optimization, product development and CMC for clinical evaluation and/or product launch (either internally and with external company collaborators). He obtained his PhD in Bioorganic Chemistry from Stanford University and was a Postdoctoral Fellow at Harvard University (Department of Chemistry and Chemical Biology). He holds more than twenty issued US patents and coauthored more than twenty scientific articles and book chapters on topics including bioorganic chemistry, biomaterials, drug delivery, bioconjugation and biologic+synthetic hybrid products.

Parag Mehta PhD

Parag G. Mehta, PhD, Co-founder and CEO 

Parag is a serial entrepreneur with a track record of commercializing novel chemistry based innovations. He has strong background in biotechnology, organic, macromolecular and biochemistry and material science. His experience encompasses product R&D, global business development, manufacturing and capitalization of companies through public and private financing.  He received his PhD in Chemistry from Rensselaer Polytechnic Institute, Troy, NY and MSc in Chemistry from Indian Institute of Technology, Mumbai, India.