Innate Pharma SA (Nasdaq: IPHA) 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