On January 12, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company has obtained a license from Novartis to develop and commercialize an antibody cytokine engrafted protein, referred to as IOV-3001 (Press release, Iovance Biotherapeutics, JAN 12, 2020, View Source [SID1234553030]). 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.
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"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.