IGM Biosciences Enters into Exclusive Licensing Agreement with Medivir for Birinapant

On January 11, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS) reported that it has entered into an exclusive license agreement with Medivir AB (Nasdaq Stockholm: MVIR), through which IGM will receive global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells (Press release, IGM Biosciences, JAN 11, 2021, View Source [SID1234573820]). The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically.

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Under terms of the agreement, Medivir will receive an upfront payment of $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in clinical Phase I studies. The terms of the agreement also entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately $350 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales.

"Based on our in vitro and in vivo models, which have shown remarkable synergy between IGM-8444 and birinapant, we are excited to explore this combination’s potential to deliver superior anti-tumor activity in patients with solid tumors," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "This agreement is part of a broader strategy to realize the full potential of our IgM drug candidates by maintaining control over the timing and development path of the more promising combinations to emerge from our preclinical and clinical work. We look forward to moving the IGM-8444-birinapant combination into clinical testing to begin validating the significance of targeting DR5 with an IgM antibody in certain combinations and to continue to explore similar strategic options across our IgM platform."

"Agreements, such as the one announced today with IGM, continue to be a core component of Medivir’s corporate mission and business model," said Yilmaz Mahshid, Chief Executive Officer of Medivir. "Today’s announcement further exemplifies our focus and commitment to the development and commercialization of innovative treatments for cancer, and we look forward to IGM’s progress in the clinic and beyond."

In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a Phase 1 dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM plans to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid tumors later this year.