Innate Pharma SA announced that the first patient has been dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 / IPH6101 (NCT05086315). This trial evaluates SAR443579 as a monotherapy for treating blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia, and high-risk myelodysplasia.
SAR443579 is an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager resulting from a joint research collaboration between Innate Pharma and Sanofi. It has received FDA Fast Track Designation for the treatment of acute myeloid leukemia. The efficacy and safety results from the dose-escalation part of the trial were presented at the American Society of Hematology 2023 Annual Meeting.
Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma, stated, "The progression of SAR443579 to the Phase 2 expansion part of the clinical trial in blood cancers is another step in bringing this innovative NK cell engager to patients. SAR443579 has shown promising clinical efficacy in the dose escalation of the Phase 1/2 in R/R AML patients, and we look forward to the dose expansion part of the study."
Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m. Peter Adamson, Global Development Head, Oncology, Sanofi, commented, "Our goal is to continue to develop the best and most impactful treatments for patients with cancer. We are encouraged by our progress in this study for patients with AML, and look forward to sharing results in the future as data continues to emerge."
More information about the Phase 1/2 trial can be found on clinicaltrials.gov.
