Iovance Biotherapeutics Obtains License to Develop and Commercialize a Novel IL-2 Analog

SAN CARLOS, CA, USA I January 12, 2020 I Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company has obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein, referred to as IOV-3001. Under the agreement, Iovance will pay an upfront payment to Novartis as well as low single digit milestones involved in initiation of patient dosing in various phases of clinical development for IOV-3001 and approval of the product in the U.S., EU and Japan. Novartis is also entitled to low-to-mid single digit royalties from commercial sales of the product.

“As we progress our development efforts to commercialize TIL, we continue exploring ways to optimize the TIL treatment regimen which includes administration of IL-2,” said Maria Fardis, Ph.D., MBA, Iovance’s President and Chief Executive Officer. “We therefore see a great strategic and long-term fit for Iovance to pursue development of a targeted and selective IL-2 analog with better pharmacokinetic properties. This product further adds to our research efforts in making safe and more potent TIL products with the potential opportunity for chronic administration.”

IOV-3001 is an engineered IL-2 CDR graft which targets IL2R beta-gamma-expressing cells and limits IL2R alpha-beta-gamma-dependent Treg activation. The protein has an improved half-life leading to a better exposure while minimizing Cmax possibly reducing the side effects associated with IL-2 protein. Iovance will focus on GMP manufacturing of IOV-3001 during 2020 and may initiate IND-enabling activities as early as 2021. 

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovance’s T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit www.iovance.com.

SOURCE: Iovance Biotherapeutics

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