Amphivena Announces New Key Leadership and Advisors

Tekla Invests in Series B Round

SOUTH SAN FRANCISCO, Calif.--()--Amphivena Therapeutics, Inc., 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), is pleased to announce 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

“Amphivena’s pioneering development work on AMV564, a novel CD33/CD3-bispecific antibody for the treatment of AML and MDS, has allowed us to attract three outstanding executives who are widely regarded as leaders in their respective fields. Their decision to join Amphivena underscores our clinical achievements and AMV564’s potential as a breakthrough therapy for AML and MDS patients. The addition of these three executives also ensures that a world-class team will lead AMV564 expeditiously through the clinic,” said Jeanmarie Guenot, Ph.D., Amphivena’s co-founder, President and Chief Executive Officer.

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, Inc. and Proteolix, Inc. where she contributed to the approvals of cancer therapeutics IMBRUVICA® and KYPROLIS®, respectively. She has been an advisor to Amphivena since 2013.

Further, funds managed by Tekla Capital Management, LLC based in Boston, MA invested in Amphivena’s Series B Financing completed in July. Christian M. Richard, M.S., M.B.A., Senior Vice President, Research, joined Amphivena’s Board of Directors.

“These events mark another milestone in Amphivena’s evolution. With a very compelling preclinical profile and exciting clinical data, AMV564 has the potential to become the best-in-class T cell engaging antibody for the treatment of AML and MDS. Dr. Feldman, a world renowned leukemia expert, brings unique experience from the clinical development of three other CD33-targeting antibodies. With our newly expanded team, a new financing in place, and active strategic discussions ongoing, Amphivena is positioned to accelerate and expand the AMV564 development program,” said Luke Evnin, Ph.D. of MPM Capital, Amphivena’s co-founder and Chairman of the Board.

Amphivena is conducting a Phase 1 clinical study of AMV564 in relapsed or refractory AML. Amphivena plans to launch a Phase 1 clinical study in patients with MDS in early 2018. The company is also exploring the utility of AMV564 in solid tumors. In preclinical studies, this novel CD33/CD3 bispecific antibody demonstrated potent activity against AML patient samples that was independent of CD33 expression level, disease stage and cytogenetic risk. The antibody eliminated nearly all blasts from bone marrow and spleen in a stringent AML patient-derived xenograft murine model. In addition, Amphivena established a therapeutic window for AMV564 in cynomologus monkeys, with rapid, sustained elimination of CD33-expressing cells during AMV564 dosing and rapid hematopoietic recovery following dosing.

Biographical Information

Eric J. Feldman, M.D.

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, Inc. 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 (GLEEVEC®) in chronic myeloid leukemia, lenalidomide (REVLIMID®) 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, Inc. 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 (SGN-CD33A) 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., Inc. 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 post-doctoral fellow in the School of Medicine, Division of Cardiology.

Deborah J. Tranowski

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, Inc. 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 department and supporting teams from preclinical through approval and commercialization (Xtandi®). She led 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, M.D.

Lori Anne Kunkel, M.D. 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, Inc., Curis, Inc., Tocagen Inc. and Maverick Therapeutics Inc. She was previously the acting Chief Medical Officer at Loxo and she served as Chief Medical Officer at Pharmacyclics, Inc. (acquired by AbbVie) and Proteolix, Inc. (acquired by Onyx Pharmaceuticals, Inc.), 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 Corporation), Stemcentrx, Inc. (acquired by AbbVie), Atreca, Inc. and Verastem, Inc.

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.

Patrick Baeuerle, Ph.D., joined MPM in 2015, and has since co-founded MPM oncology start-ups: Harpoon Therapeutics, Inc., TCR² Therapeutics, iOmx Therapeutics AG, Maverick Therapeutics, Inc. and Cullinan Pharmaceuticals LLC. Previously, he was responsible for the development of BiTE antibody Blincyto®, which was approved in 2014 within three months of submission by the U.S. 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 GmbH, where he oversaw translational sciences of BiTE antibodies. From 1998 to 2012, he served as Chief Scientific Officer for Micromet, Inc., and earlier headed small molecule drug discovery at Tularik, Inc., a publicly traded biotechnology company also acquired by Amgen (AMGN). 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 64,000 times 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.

About Amphivena Therapeutics

Amphivena Therapeutics, founded in 2013, is a private biotechnology company developing AMV654, a CD33/CD3-bispecific T cell engaging antibody for the treatment of AML and MDS. MPM Capital, Amphivena’s major shareholder, led a $19.5 M Series A financing, with participation by Aeris Capital and Affimed GmbH. More recently, funds managed by Tekla Capital Management LLC joined the founding investors in a Series B financing. For more information, please visit www.amphivena.com.

Contacts

Amphivena Contact:
Shari Annes
sannes@annesassociates.com

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