SAR’579 / IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies

On June 8, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported Sanofi’s news that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR’579 / IPH6101 for the treatment of hematological malignancies (Press release, Innate Pharma, JUN 8, 2023, View Source [SID1234632601]).

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Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.

SAR’579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi.

"It is promising to see SAR’579 / IPH6101 was granted Fast Track Designation in the US for the treatment of hematological malignancies, and congratulate our partner Sanofi on this milestone," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "In addition to the encouraging clinical data recently presented at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, this FDA Fast Track Designation further validates the potential of the ANKET platform to treat cancer patients with NK Cell Engagers."

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.