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Innate Pharma Shares Updated Results From the Sanofi Developed Blood Cancer Phase 1/2 SAR443579/IPH6101 Trial
Innate Pharma's Phase 1/2 trial of SAR443579 (SAR’579), developed with Sanofi, continues to show promising results for treating relapsed/refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), and high-risk myelodysplasia (HR-MDS). The clinical trial results, presented at the European Hematology Association 2024 Congress, highlight 5 complete remissions at a 1 mg/kg dose, with 3 patients achieving durable CR over 10 months. SAR’579 has an FDA Fast Track Designation for acute myeloid leukemia and has shown a favorable safety profile at doses up to 6 mg/kg weekly. The study has now progressed to Phase 2, focusing on further demonstrating the efficacy of this NK cell engager.
MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced today that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR'579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET® platform lead asset, were shared in an oral presentation at the European Hematology Association 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST. The study, led by Sanofi, tests SAR’579 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). SAR’579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia. “We are pleased to see that SAR’579 continues to show promising and durable clinical efficacy along with a favorable safety profile. The ongoing Phase 1/2 study has recently progressed to the Phase 2 stage, marking a significant milestone in its development. We look forward to the continued progress of this multi-specific NK Cell Engager which holds great potential to benefit patients suffering from various blood cancers,” says Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.
Fifty-nine patients (58 R/R AML and 1 HR-MDS) across 11 dose levels (0.01 – 6mg/kg) were treated. Patients had received a median of 2 (1 – 10) prior lines of treatment. A maximum response rate was observed at a final target dose of 1 mg/kg every week with 5 AML patients achieving a CR (4 CR/1 CRi)1. The median treatment duration was 7.9 weeks, with durable CR (>10 months) observed in 3 patients with 2 remaining on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg every week. These data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial.
“We are excited about the emerging results from our development of SAR’579. Ongoing studies are focused on further demonstrating the potential of the NK cell engager in patients with leukemia. We look forward to sharing data from these trials at future scientific meetings,” says Peter Adamson, Global Development Head, Oncology, Sanofi.
“We are excited about the emerging results from our development of SAR’579. Ongoing studies are focused on further demonstrating the potential of the NK cell engager in patients with leukemia. We look forward to sharing data from these trials at future scientific meetings,” says Peter Adamson, Global Development Head, Oncology, Sanofi.
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