Date: 2017-09-11
Type of information: Nomination
Compound:
Company: Amphivena Therapeutics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: nomination
Action mechanism:
Disease:
Details:
- • On September 11, 2017, Amphivena Therapeutics, a privately held biotechnology company developing a novel CD33/CD3-bispecific T cell engaging antibody for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), announced three additions to the company’s leadership team:
- • Eric J. Feldman, M.D., Senior Vice President, Clinical Development
- • Tae H. Han, Ph.D., Vice President, Clinical Pharmacology and Translational Medicine
- • Deborah J. Tranowski, Vice President, Program Management & Operations
- In addition, Dr. Patrick Baeuerle joins Dr. Lori Kunkel as a clinical and scientific advisor to Amphivena. Dr. Baeuerle is a pioneer in T cell therapy and the development of bispecific T cell-engaging antibodies. At Micromet and Amgen, he invented and developed a number of T cell engagers, including Blincyto™and AMG330, a CD33/CD3-bispecific BiTE™ antibody. Dr. Kunkel was Chief Medical Officer at both Pharmacyclics and Proteolix where she contributed to the approvals of cancer therapeutics Imbruvica® and Kyprolis®, respectively. She has been an advisor to Amphivena since 2013.
- Eric J. Feldman, M.D. is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders. Dr. Feldman joins Amphivena from the clinical research group at Seattle Genetics where he oversaw the myeloid leukemia antibody-drug conjugate (ADC) program. Dr. Feldman has had an extensive academic career, most recently as Professor of Medicine and Director of the Hematological Malignancies Service at Weill-Cornell/New York Presbyterian Hospital. He has led or participated in the conduct of numerous clinical trials, several leading to FDA approval including imatinib in chronic myeloid leukemia, lenalidomide in myelodysplastic syndrome, and most recently, CPX-351 (Vyxeos™) in acute myeloid leukemia. Dr. Feldman has focused throughout his career on the clinical development of CD33-targeted therapies including lintuzumab (Zamyl™), gemtuzumab ozogamicin (Mylotarg™), and most recently, vadastuximab talirine (SGN-CD33A). In addition to his faculty appointment at Weill-Cornell, he has served on the faculty at New York Medical College and the University of Texas, MD Anderson Cancer Center. Dr. Feldman has authored over 150 scientific articles and is currently Editor-in Chief of the journal Leukemia Research.
- Tae H. Han, Ph.D.Tae H. Han, Ph.D. has extensive experience with nonclinical and clinical development for both small molecule drugs and antibody-based therapeutics. Before joining Amphivena, Dr. Han led the clinical pharmacology, DMPK, and toxicology functions at AbbVie Stemcentrx and was the South San Francisco site lead for clinical pharmacology and pharmacometrics at AbbVie. There, he supported the development of rovalpituzumab tesirine, a targeted ADC against cancer stem cells in small cell lung cancer, in addition to supporting the overall pipeline of antibody-drug conjugates for the treatment of solid tumor cancers. Prior to AbbVie Stemcentrx, Dr. Han was the head of clinical pharmacology at Seattle Genetics, Inc. and was the clinical pharmacology and DMPK lead for the world-wide approval of Adcetris™, an ADC for the treatment of Hodgkin and anaplastic large cell lymphoma. In addition, Dr. Han supported the development of lintuzumab (SGN-33, Zamyl™) and vadastuximab talirine (SGNCD33A)during his time at Seattle Genetics. Prior to working on antibody-drug conjugates, Dr. Han supported preclinical and clinical drug development of small molecule and peptide drugs in multiple therapeutic areas including metabolic, cardiovascular, and neuroscience at Merck and Co.Dr. Han received his B.S. in Chemical Engineering from the University of Washington, and Ph.D. in Chemical and Biomolecular Engineering from the University of California, Los Angeles where he also trained as a postdoctoralfellow in the School of Medicine, Division of Cardiology.
- Deborah J. Tranowski comes to Amphivena with over 15 years of experience leading teams and providing clinical, project/alliance management and regulatory expertise to the biotechnology and pharmaceutical industries. She joins Amphivena from Coherus BioSciences, where she was Executive Director, Product Development, leading late-stage, partnered biosimilar programs. Prior to Coherus, Tranowski was Sr. Director, Project & Portfolio Management at Medivation Inc. responsible for building the Program and Alliance Management departmentand supporting teams from preclinical through approval and commercialization (Xtandi®). Sheled cross-functional development teams responsible for registrational submissions at Tercica, Inc. (Increlex®) and Medimmune/Aviron (FluMist®). Tranowski began her career as a computer scientist, working for Booz Allen & Hamilton. She received a B.S. in Computer Science and Mathematics from the University of Maryland and is completing Stanford University’s Advanced Project Management program.
- Lori Anne Kunkel, MD. has more than two decades of experience in oncology and immunology drug development and commercialization. Dr. Kunkel presently serves on the Board of Directors of Loxo Oncology, Curis, Tocagen and Maverick Therapeutics. She was previously the acting Chief Medical Officer at Loxo and she served as Chief Medical Officer at Pharmacyclics (acquired by AbbVie) and Proteolix, (acquired by Onyx Pharmaceuticals), contributing to the approvals of cancer therapeutics Imbruvica® and Kyprolis®, respectively. She has advised multiple clients including Chiron Corporation (acquired by Novartis), Genentech/Roche, Salmedics (acquired by Celgene), Stemcentrx (acquired by AbbVie), Atreca and Verastem. Dr. Kunkel served as a faculty member in the Division of Hematology/Oncology at University of California, Los Angeles. Dr. Kunkel obtained a medical degree from University of Southern California and a bachelor's degree in biology from University of California, San Diego. She is board certified in internal medicine and held board certifications in hematology and oncology.
- Patrick Baeuerle, Ph.D., joined MPM in 2015, and has since co-founded MPM oncology start-ups:Harpoon Therapeutics, TCR² Therapeutics, iOmx Therapeutics, Maverick Therapeutics, and Cullinan Pharmaceuticals. Previously, he was responsible for the development of BiTE antibody Blincyto®, which was approved in 2014 within three months of submission by the FDA for the treatment of relapsed/refractory acute lymphoblastic leukemia. He also spearheaded the BiTE technology, the industry’s leading T-cell engaging bispecific antibody platform.Prior to joining MPM, Dr. Baeuerle served as Vice President, Research, and General Manager of Amgen Research Munich, where he oversaw translational sciences of BiTE antibodies. From 1998 to 2012, he served as Chief Scientific Officer for Micromet, and earlier headed small molecule drug discovery at Tularik, , a publicly traded biotechnology company also acquired by Amgen. From 1996-1998, he served as Professor and Chairman of Biochemistry and Molecular Biochemistry at the Medical Faculty of Freiburg University, Germany, where he did groundbreaking research on transcription factor NF-kappaB. Dr. Baeuerle has published more 238 PubMed-listed papers that have been cited more than 64,000times to date. He has a Hirsh index of 119 and was rated Germany’s most frequently cited biomedical scientist of the decade (1990-1999), and among the top 50 worldwide (1990 to 1997). He holds a Ph.D. in biology from the University of Munich, and performed post-doctoral research with Dr. David Baltimore at the Whitehead Institute at the Massachusetts Institute of Technology. He is also an Honorary Professor of Immunology of the Medical Faculty at Munich University.
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