Iovance Biotherapeutics Obtains License to Develop and Commercialize A Novel II-2 Analog
January 12, 2020 at 04:30 pm EST
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Iovance Biotherapeutics, Inc. 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. 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.
Iovance Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company develops and delivers tumor infiltrating lymphocyte (TIL), therapies for patients with solid tumor cancers. Its lead product candidate, Amtagvi (lifileucel), is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The Company also marketing Proleukin (aldesleukin), aninterleukin-2, or IL-2, product used in the Amtagvi treatment regimen. Its development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers. Amtagvi and Proleukin are part of a treatment regimen that also includes lymphodepletion. The Company is also developing next generation therapies using TIL, such as genetically modified TIL cell therapy.