drugset / Press release

Innate Pharma shares efficacy and safety Phase 1 /2 results of NK Cell Engager SAR443579 / IPH6101 developed by Sanofi at ASH 2023

2023-12-11 · Innate Pharma · original innate-pharma.com ↗

SAR443579/IPH6101, ANKET ® platform lead asset, is a first-in-class NKp46/CD16-based NK cell engager targeting CD123 from a joint research collaboration between Innate Pharma and Sanofi, under development by Sanofi SAR443579 induced clinical benefit in patients with R/R AML with 5 complete remissions (4 CR / 1 CRi) achieved at 1 mg/kg, and was well tolerated up to doses of 6 mg/kg SAR443579 demonstrated durable responses with two responders remaining in remission beyond 8.8 and 12.2 months of treatment Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) announced today that the updated efficacy and safety results from an open-label, first-in-human, Phase 1/2 dose-escalation study of SAR443579 / IPH6101, an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE) from a joint research collaboration between Innate Pharma and Sanofi were shared in a poster presentation at the American Society of Hematology 2023 Annual Meeting in San Diego, California. The study, run by Sanofi, tests SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) and high-risk myelodysplasia (HR-MDS). SAR443579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia. As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across 8 dose levels between 10 – 6000 μg/kg/dose were available for analysis. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoietic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. At the highest dose of 1000 μg/kg QW, 5/15 (33.3%) patients with AML achieved a CR (4 CR / 1 CRi)1. SAR443579 was well tolerated up to 6000 μg/kg QW with observed clinical benefit in patients with R/R AML, in line with the predicted favorable safety profile. “ We are pleased to see that SAR443579 continues to show promising durable clinical efficacy with now 5 complete remissions along a favorable safety profile in this Phase 1/2 dose escalation study in various blood cancers, ” says Sonia Quaratino, Chief Medical Officer of Innate Pharma . “ We look forward to continue to advance the development of multi-specific NK Cell Engagers for the treatment of cancer with our ANKET platform ® and continuing our partnership with Sanofi .” “ Sanofi is pleased to share these emerging results from our study of SAR443579, ” states Peter Adamson, Global Development Head, Oncology, Sanofi . “ We believe this investigational NK cell engager may be important to patients with AML who, too often, have limited therapeutic options available to them. Our updated results help drive Sanofi R&D teams around the world to continue efforts to develop impactful treatments for diseases with high unmet medical needs. ” 1 CR: complete remission; CRi: CR with incomplete hematological recovery About ANKET ® ANKET ® ( A ntibody-based NK cell E ngager T herapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About the Innate-Sanofi research collaboration and licensing agreements The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells. Under the terms of the 2016 research collaboration and license agreement , Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes IPH6101/SAR’579 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and IPH6401/SAR’514 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. As part of the license agreement entered in December 2022 , Sanofi licensed IPH62 and has the option for two additional targets. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Subscribe to our newsletter Contact us 117, Avenue de Luminy - BP 30191 13 009 Marseille FRANCE +33 (0)4 30 30 30 30

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