On September 12, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective medicines to treat a wide range of cancers, reported the appointment of Jeffrey D. Bloss, M.D., as Chief Medical Officer (Press release, Tarveda Therapeutics, SEPT 12, 2018, View Source [SID1234529408]). In addition, the company strengthened its clinical leadership team with the appointment of Steven A. Hamburger, Ph.D. as Vice President, Regulatory Affairs and Laura Mei as Vice President, Clinical Operations.
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"We are very pleased to have Jeff join Tarveda at this exciting time for our Company. Jeff brings deep expertise and over two decades of experience leading the clinical development and medical affairs of oncology programs at both biotech and pharmaceutical companies. His track record of success, including taking numerous oncology drug programs through development and approval, will be invaluable to Tarveda as we continue to advance our two clinical stage drug programs and pipeline," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "Further, with the additions of Laura and Steve leading Clinical Operations and Regulatory Affairs, respectively, we have greatly strengthened our ability to optimize and execute the development of our two current clinical programs as well as future pipeline opportunities."
In the second quarter of 2018, Tarveda announced the initiation of the Phase 2a expansion portion of its Phase 1/2a trial for PEN-221 in patients with somatostatin receptor 2-expressing neuroendocrine tumors and small cell lung cancer. In the same quarter, Tarveda also announced the commencement of the dose escalation portion of its Phase 1/2a trial for PEN-866 in patients with solid malignancies.
"I am pleased to join Tarveda and am impressed with the novel approach of our new class of selective and potent miniature conjugates as well as by the clinical data from our two clinical stage drug programs," said Dr. Jeffrey Bloss. "Both PEN-221 and PEN-866 have the potential to dramatically improve the treatment of patients with solid tumors by leveraging the small size of the conjugates to rapidly penetrate deep into solid tumors while leading to the prolonged accumulation of their potent therapeutic payloads in the tumor versus healthy tissues. I am eager to advance the clinical development of both clinical stage drug programs and look forward to working side by side with Laura, Steve and the entire team to fully explore the potential of our drugs in treating patients with cancer."
Jeffrey D. Bloss, M.D., Chief Medical Officer
During his career encompassing more than 25 years in oncology, Dr. Bloss has held many leadership roles and has been responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar, Tarceva, Sorafenib, Tykerb, Xtandi and others. Prior to joining Tarveda, Dr. Bloss served as Chief Medical Officer and Senior Vice President, Medical Affairs at Aegerion. He has also held senior level positions at Astellas, GlaxoSmithKline, Xencor, Onyx, Genentech, and Eli Lilly. Before joining the biotech industry, Dr. Bloss held a series of roles of increasing responsibility at the University of Missouri, Ellis Fischel Cancer Center and at the USAF Medical Corps. He holds an M.D. from Thomas Jefferson University Medical College and a B.S. from Juniata College. Dr. Bloss completed his Residency in Obstetrics & Gynecology at Wilford Hall USAF Medical Center and his Fellowship in Gynecologic Oncology at the University of California, Irvine.
Steven A. Hamburger, Ph.D., Vice President, Regulatory Affairs
Prior to joining Tarveda, Dr. Hamburger served as Vice President, Regulatory Affairs and Quality Assurance at BERG. He has led global regulatory efforts for both biotech and large pharmaceutical companies including Castle Creek Pharmaceuticals, Baxalta and Immunomedics. Dr. Hamburger has also held senior regulatory positions at Millennium/Takeda, Johnson & Johnson, Eli Lilly, and Zeneca Pharmaceuticals. He has had significant involvement in the development and/or global registration of many drugs including Krystexxa, Onivyde, Oncaspar, Velcade, Alimta, DOXIL and Accolate. Dr. Hamburger holds a Ph.D. in Pharmacology and Toxicology from Indiana University School of Medicine, an M.S. from Butler University and a B.S. from the University of Iowa.
Laura Mei, Vice President, Clinical Operations
Prior to joining Tarveda, Ms. Mei served as Executive Director, Global Clinical Operations and Metabolic Franchise Head at Alexion Pharmaceuticals. She has also held management positions at several biotech and pharmaceutical companies including Senior Director, Clinical Operations at Synageva Biopharma, Senior Director, Clinical Operations and GCP Compliance at Alexza Pharmaceuticals and Associate Director, R&D Compliance at Biogen. Ms. Mei holds a B.A. in physics and zoology from Connecticut College.
About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.