Sanofi and Innate Pharma SA have expanded their collaboration, with Sanofi licensing a natural killer (NK) cell engager program targeting B7H3 from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform. \n\n\n\nSanofi will also have the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Innate Pharma and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofi’s R&D team, with one of these molecules already in clinical studies.\n\n\n\nValeria Fantin, global head of oncology research at Sanofi, said: “At Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of next-generation NK cell engagers, highly synergistic with Sanofi’s allogeneic NK cell platform, engineered lymphokines that stimulate NK cells, and growing immuno-oncology pipeline. As a leading global company with roots in France, we are proud to collaborate to support the French healthcare ecosystem."\n\n\n\nBuilding on success\n\n\n\nYannis Morel, executive vice president, product portfolio strategy & business development at Innate Pharma, said: “Building on the success of our existing collaboration on hematologic targets, we are pleased to expand and strengthen our partnership with Sanofi on NK Cell Engagers with the addition of up to three new programs, including in solid tumors. \n\n\n\n"Sanofi’s investment in Innate further validate the value of our ANKET platform and its potential to address multiple tumor types. By incorporating various tumor antigen binders, NK Cell Engagers are a versatile technology that may provide new options for patients and offer clinical benefit across multiple cancers, whilst also maintaining a good safety profile. This agreement also highlights Innate’s strategy to build a broad portfolio of ANKET programs addressing different types of cancer.”\n\n\n\nUnder the terms of the new license agreement, Innate will receive €25 million ($26.6 million) upfront payment and up to €1.35 billion ($1.4 billion) total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Closing of the transaction is subject to HSR approval.\n\n\n\n2016 agreement between Sanofi and Innate Pharma\n\n\n\nIn 2016, Sanofi and Innate entered into a research collaboration and licensing agreement for the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi’s proprietary bispecific antibody format as well as tumor targets. \n\n\n\nA phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579, the first NKp46/CD16-based CD123-targeted ANKET NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS). \n\n\n\nIn summer 2022, Sanofi made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE multi-functional platform, which comprises the cross-over-dual-variable-domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET proprietary platform.\n\n\n\nUnder the terms of the original license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible for to up to €400 million ($425 million) in development and commercial milestone payments as well as royalties on net sales. To date, €13 million ($13.8 million) milestone payments to Innate have been announced.