Sanofi's NKp46/CD16/CD123 Trispecific Antibody SAR443579 Granted Clinical Trial Approval in China for Relapsed/Refractory Hematologic Malignancies

On May 31, the CDE website showed that Sanofi's NKp46/CD16/CD123 tri-specific antibody SAR443579 for injection was approved for clinical use to treat patients aged 12 years and above with relapsed/refractory hematologic malignancies.

SAR443579 is a NK cell engager based on NKp46/CD16 developed by Sanofi in collaboration with Innate Pharma, utilizing Innate's proprietary multispecific antibody platform ANKET. It is intended for patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS) and is currently in Phase I clinical trials.

In 2016, Innate and Sanofi signed the first NK cell engager collaboration agreement to generate and evaluate two bispecific NK cell engagers. Currently, Sanofi's R&D team is evaluating these bispecific NK cell engagers, and one of the molecules has already entered clinical research. In 2022, the two parties expanded their collaboration in the field of NK cell therapy.

Previously, Innate had reached an agreement with Sanofi, under which Sanofi would pay Innate a milestone payment of 7 million euros once SAR443579 was identified as a clinical development candidate. Sanofi will be responsible for all future development, manufacturing, and commercialization activities related to SAR443579.

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