Veteran biopharma leader with track record of driving regulatory innovation and supporting commercialization of biologic and cancer therapies added to leadership team
Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, today announced that it has hired Robert Pietrusko, PharmD, as Chief Regulatory and Quality Officer. Dr. Pietrusko is an accomplished biopharma executive with over 30 years of regulatory affairs and drug development experience across a range of indications and modalities, and most recently served as Senior Vice President, Regulatory Affairs and Quality Assurance at gene therapy developer Voyager Therapeutics.
"Bob’s deep relationships with key players advancing the frontiers of cell and gene therapy are testament to a highly successful career focused on bringing new medicines and modalities to patients," said Robert Ang, MBBS, MBA, Vor President and Chief Executive Officer. "His years of experience and industry leadership, in addition to his specific expertise in regulatory affairs, will provide vital strategic direction to bring our engineered hematopoietic stem cells to patients living with acute myeloid leukemia and other blood cancers."
Dr. Pietrusko has directed the worldwide approval of more than 30 new products. He also led the submission and approval strategies for more than 30 new drug applications (NDAs), supplemental NDAs, biologics license applications and marketing authorization applications in multiple therapeutic areas. As an early team member at Voyager Therapeutics, Dr. Pietrusko pioneered regulatory strategies to translate gene therapies from research into the clinic. Prior to Voyager, Dr. Pietrusko was Vice President of Global Regulatory Affairs & Quality and Executive Officer at ViroPharma, Inc. He also served as Senior Vice President of Regulatory Affairs at Millennium Pharmaceuticals, spearheading the accelerated approval of Velcade® in the U.S. and in more than 90 countries worldwide. Earlier in his career, he was Vice President of Regulatory Affairs at SmithKline Beecham (now GlaxoSmithKline).
Dr. Pietrusko has played a key role in shaping U.S. regulatory policy for cutting edge medicines, such as recently pioneering the concept of an expedited pathway to approval for cell and gene therapies that led to the Regenerative Medicine Advanced Therapy (RMAT) designation process that was included in the United States’ 21st Century Cures Act. He is a member of the Regulatory Affairs committee of the American Society of Gene and Cell Therapies (ASGCT). Dr. Pietrusko holds a Bachelor of Science degree in biology and a Bachelor of Pharmacy degree from Rutgers University, and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science. He completed his residency training in hospital pharmacy at Thomas Jefferson University Hospital and is the author or co-author of over 50 scientific publications.
"Vor’s innovative approach to engineering hematopoietic stems cells to render them ‘invisible’ to targeted therapies holds enormous potential to bring durable clinical efficacy to patients with few treatment options, driving one of the most exciting areas in cancer research," Dr. Pietrusko said. "I am excited to join a strong team with fresh scientific thinking and a clear vision for how they can make a significant contribution to the treatment of cancer, especially at this pivotal stage as the company prepares its first IND filing for its lead program VOR33."
About Vor Biopharma
Vor Biopharma aims to transform the lives of cancer patients by pioneering engineered hematopoietic stem cell (eHSC) therapies. By removing biologically redundant proteins from eHSCs, these cells become inherently invulnerable to complementary targeted therapies while tumor cells are left susceptible, thereby unleashing the potential of targeted therapies to benefit cancer patients in need.
Vor’s platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as antibody drug conjugates, bispecific antibodies and CAR-T cell treatments. A proof-of-concept study for Vor’s lead program has been published in Proceedings of the National Academy of Sciences.
Vor is based in Cambridge, Mass. and has a broad intellectual property base, including in-licenses from Columbia University, where foundational work was conducted by inventor and Vor Scientific Board Chair Siddhartha Mukherjee, MD, DPhil. Vor was founded by Dr. Mukherjee and PureTech Health and is supported by leading investors including 5AM Ventures and RA Capital Management, Johnson & Johnson Innovation — JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research and Osage University Partners.
Vor’s lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, CD33 becomes a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. In so doing, Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from AML.