Pharma Focus Europe

FDA Grants Fast Track Designation to SAR'579 / IPH6101 for the Treatment of Hematological Malignancies

Thursday, June 08, 2023

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR’579/IPH6101, a potential treatment for hematological malignancies. Fast Track Designation is a process established by the FDA to expedite the development and review of medicines targeting serious conditions with unmet medical needs. This designation aims to deliver important new drugs to patients sooner and encompasses a wide range of severe illnesses.

SAR’579 is the lead asset from the ANKET® platform, developed through a research collaboration between Innate Pharma and Sanofi. It is a trifunctional anti-CD123 NKp46×CD16 NK cell engager. Sanofi, as Innate Pharma's partner, is currently responsible for the development of SAR’579.

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, expressed enthusiasm about the Fast Track Designation granted to SAR’579/IPH6101 for hematological malignancies. He congratulated Sanofi on achieving this milestone and highlighted the positive clinical data presented at the 2023 ASCO Annual Meeting. Mahjoubi emphasized that this FDA designation further validates the potential of the ANKET® platform in treating cancer patients with NK Cell Engagers.

ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate Pharma's proprietary platform for developing multi-specific natural killer (NK) cell engagers to treat specific types of cancer. This technology enables the creation of a new class of molecules that induce synthetic immunity against cancer.

Innate Pharma and Sanofi have a research collaboration and license agreement to apply Innate Pharma's proprietary technology to the development of innovative multi-specific antibody formats. These formats engage NK cells through the activating receptors NKp46 and CD16, enabling the killing of tumor cells. Sanofi is responsible for the development, manufacturing, and commercialization of products resulting from this collaboration. The agreement includes SAR’579/IPH6101 and another molecule, SAR’514/IPH6401. Innate Pharma is eligible to receive up to €400 million in development and commercial milestone payments, as well as royalties on net sales, as part of the agreement.

In December 2022, another license agreement was entered into, which includes IPH62 and two options.

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