Healthcare Industry News: CAR T-cell therapy
News Release - October 25, 2022
Actinium Bolsters its Senior Leadership Team Ahead of Upcoming Clinical Data for Iomab-BJenny Hsieh joins Actinium as Chief Strategy Officer from Gilead Sciences, following its acquisition of Immunomedics
Sunitha Lakshminarayanan, Senior Vice President, Head of CMC and Product Development, joins from Bristol Myers Squibb, and significantly strengthens team with high-impact hires
Stephen Dressel brings nearly 20 years of finance and commercial experience from Regeneron and high-growth biotechnology companies
NEW YORK, Oct. 25, 2022 -- (Healthcare Sales & Marketing Network) -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies, today highlighted multiple additions to its senior leadership team including Jenny Hsieh as Chief Strategy Officer, Sunitha Lakshminarayanan, as Senior Vice President, Head of CMC and Product Development, and Stephen Dressel as Vice President, Strategic Finance and Analysis. In addition, Sunitha has fortified the company's CMC organization and capabilities with Directors, Peter Baker, PhD, and Micah Riskin, MS, MBA, who respectively managed production and site expansion efforts for the radiotherapies Pluvicto® and Lutathera® at Novartis and supported clinical and commercial cellular therapy products at Bristol-Myers Squibb. Collectively, these hires add high-impact experience as the company gears up for major corporate activities post-topline data from the Iomab-B SIERRA trial and survival data from the Actimab-A CLAG-M combination trial, both expected this quarter.
Sandesh Seth, Actinium's Chairman and Chief Executive Officer, said, "We are excited by our continued ability to attract top talent to Actinium as evidenced by these recent leadership appointments. We believe that our differentiated pipeline of targeted radiotherapies, near-term clinical milestones and strong balance sheet allow us to attract individuals with highly relevant experience and strong track records of success. These additions to our team significantly enhance our ability to execute our plan across key functions, as we prepare for the cascade of activities following upcoming topline data results from our pivotal Phase 3 trial for Iomab-B, a key milestone in advancing our objective of bringing this potentially life-saving and practice changing product candidate to market."
"I feel fortunate to be joining Actinium at this critical time to help build the company with its robust and highly differentiated radiotherapeutics pipeline. I am excited to bring my experiences from Immunomedics' growth and its transformation into a commercial organization to Actinium," said Jenny Hsieh. Sunitha Lakshminarayanan added, "I'm thrilled to join Actinium at this important time to contribute my extensive CMC experience and track record of multiple successful health authority filings including BLAs and approvals. I am grateful for the opportunity to lead the CMC and product development efforts to bring innovative medicines to patients with a hyperfocus on quality and seamless delivery."
Jenny Hsieh, MBA, MPA – Chief Strategy Officer
Jenny has nearly two decades of experience in leading and developing corporate strategies across the healthcare and life sciences industries. Prior to joining Actinium, Jenny was the Head of Corporate Strategy at Immunomedics and helped transform the clinical-stage company into a commercial organization. Following its FDA approval of Trodelvy®, Immunomedics was acquired by Gilead Sciences for $21 billion. Previously, she was the Director of Corporate Strategy at Quest Diagnostics and a management consultant at several firms, where she advised healthcare and life sciences companies on their strategic plans to drive innovation and meaningful change in the industry. She has a BA from the University of Pennsylvania, an MBA from NYU's Stern School of Business and an MPA from NYU's Wagner Graduate School of Public Service.
Sunitha Lakshminarayanan, MBA, MS – SVP, Head of CMC and Product Development
Sunitha is a seasoned executive with over 20 years of experience and brings to Actinium broad-based technical expertise across biologics, biosimilars, vaccines and cell/gene therapy products. Prior to joining Actinium, Sunitha was at Bristol-Myers Squibb in their Cell Therapy division, most recently as Executive Director, Global Process Engineering. During her tenure at Celgene/BMS, she was responsible for the global licensure of their two autologous cell therapy products, Breyanzi® and Abecma®. Post-approval, she built the teams that provided support for commercial products. She was also responsible for new cell therapy facility build-outs for network expansions, technology transfers, product life-cycle management, new technology commercialization, comparability, and Global MS&T labs. Prior to BMS, Sunitha was at Kashiv BioSciences where she built the process development and technical services teams, led filing activities, and obtained approvals for Releuko® and Fylnetra®. Prior to Kashiv, Sunitha has held various leadership positions at Progenics Pharmaceuticals, Laureate Pharma and BioReliance. Sunitha earned her MBA from Northwestern University, Master's in Chemical Engineering from Penn State University and BS in Chemical Engineering from the Coimbatore Institute of Technology, India.
Stephen Dressel, MBA – Vice President, Strategic Finance and Analysis
Steve has nearly 20 years of corporate finance and commercial experience. He joins from Dewpoint Therapeutics, where he was Senior Director, Financial Planning & Analysis responsible for overseeing budgeting, long-term planning and analyses. Previously, he was Senior Director, Head of Corporate Planning & Operations at Akebia Therapeutics, a publicly traded, commercial-stage company that developed and marketed Auryxia®. Steve spent 10 years at Regeneron in finance roles with increasing responsibility rising to Director, Commercial Finance supporting Praulent and EYLEA, a top 5 biologic launch, where he developed and managed 10-year forecasts and $250 million budgets. He transitioned to commercial roles in the cardiometabolic franchise culminating as Director, Market Access Strategy. He began his career at Bio-IB, a life science focused investment bank, where he helped execute financings, M&A, licensing and corporate advisory assignments. Steve has his MBA from Fordham University and BA degree from the University of Colorado.
Peter Baker, Ph.D. – Director, Drug Substance/Drug Products Operations
Peter was most recently the Head of Production and oversaw the clinical and commercial manufacturing of radioligand therapeutics at Advanced Accelerator Applications, Inc. (AAA), a Novartis company. At Novartis, Peter was responsible for the manufacturing of Lutathera® and Pluvicto®. He supported the successful commercial launch of Pluvicto® for patients with prostate cancer and increased manufacturing capacity for Lutathera® for patients with neuroendocrine tumors. Prior to AAA, Peter worked for Regeneron and Merck where he supported aseptic manufacturing of Drug Product in a variety of capacities including MSAT, Validation, Operations, Engineering and Facility design. Peter received his Ph.D. from NYU in Biomedical Engineering.
Micah Riskin, MBA, MS – Director, Product Steward, Manufacturing Sciences & Technology
Micah brings a wealth of experience in process development and manufacturing sciences from various biotechnology and pharmaceutical companies. Micah was most recently the Process Development and Manufacturing Sciences and Technology (PD/MSAT) Lead/Director at Imvax. At BMS, he was the Global Validation Lead responsible for the Abecma® PPQ campaign, filing and approval. Previously, Micah held various MSAT, Process Development and Quality roles at Celgene, Biomarin, MedImmune and Imclone in Biologics, Cell and Gene Therapy supporting clinical and commercial products. Micah has a BS in Chemical Engineering and MS in Applied Statistics from Penn State and an MBA from Rutgers.
Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium's clinical pipeline is led by radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients, including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Topline data from the SIERRA trial are expected in the fourth quarter of 2022. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in ongoing combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 190 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPα inhibitor. More information is available on Actinium's website: https://www.actiniumpharma.com/.
Source: Actinium Pharmaceuticals
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