Innate announces updated efficacy, safety results from SAR443579 / IPH6101 study

Innate Pharma (IPHA) announced 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, or NKCE, from a joint research collaboration between Innate Pharma and Sanofi (SNY) 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, B-cell acute lymphoblastic leukemia, or B-ALL, and high-risk myelodysplasia. SAR443579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia. As of July 5, 43 patients across eight dose levels between 10 – 6000 undefined/kg/dose were available for analysis. Patients had received a median of two prior lines of treatment with 13 patients reporting prior hematopoietic stem cell transplantation and 36 patients with prior exposure to venetoclax. At the highest dose of 1000 undefined/kg QW, 5/15 patients with AML achieved a CR. SAR443579 was well tolerated up to 6000 undefined/kg QW with observed clinical benefit in patients with R/R AML, in line with the predicted favorable safety profile.