Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) announced the appointment of Marc R. Theoret, M.D., as Senior Vice President, Regulatory Strategy, effective immediately. The newly created position will focus on clinical regulatory strategy for Iovance's pipeline of tumor infiltrating lymphocyte (TIL) therapies. Dr. Theoret will report to Dr. Raj K. Puri, M.D., Ph.D., Chief Regulatory Officer.
Extensive FDA Leadership Experience
Dr. Theoret brings more than 15 years of experience from the United States Food and Drug Administration (FDA), where he held various roles within the Oncology Center of Excellence (OCE) and the Center for Drug Evaluation and Research (CDER). For the past five years, he served as Deputy Center Director, OCE and Acting Supervisory Associate Director in the Office of Oncologic Diseases (OOD), CDER.
In his FDA leadership roles, Dr. Theoret led regulatory reviews of drugs and biologics for hematological malignancies and solid tumors, including melanoma and tissue agnostic development. He contributed to the approval of numerous oncology applications and is a past recipient of the FDA Scientific Achievement Team Award for Excellence in Review Science.
Prior to his FDA tenure, Dr. Theoret spent three years conducting adoptive cellular therapy trials for patients with melanoma and other solid tumors and translational science research at the National Cancer Institute as a clinical fellow in Hematology/Oncology. He previously served as Intern and Resident in Internal Medicine, and Clinical Fellow at Harvard Medical School, Beth Israel Deaconess Medical Center.
Strategic Regulatory Leadership
"We are excited to welcome Marc to Iovance as we further our mission of developing and delivering novel therapies to patients with solid tumors," said Dr. Puri. "Marc's extensive regulatory expertise and leadership experience within the FDA's Oncology Center of Excellence will be a significant contribution as we advance our pipeline and regulatory strategies across multiple solid tumor cancers."
Iovance's TIL Therapy Platform
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. The company is pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient.
The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication, marking a significant milestone in the field of cellular immunotherapy. The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
Pipeline and Commercial Portfolio
Iovance's commercial portfolio includes both Amtagvi, which has obtained FDA approval, and Proleukin, for which the company has obtained FDA and European Medicines Agency (EMA) approval. The company is also pursuing marketing authorization application submission for lifileucel in metastatic melanoma with the EMA and other ex-U.S. regulatory authorities.
The company's clinical development program includes ongoing trials across multiple solid tumor indications, with the planned single arm Phase 2 IOV-LUN-202 trial representing a key component of their registration strategy. The appointment of Dr. Theoret comes at a critical time as Iovance continues to advance its pipeline and regulatory strategies across multiple solid tumor cancers.
