Innate Pharma announces drug researched with Sanofi receives FDA Fast Track Designation
Innate Pharma has announced that the drug jointly researched between itself and Sanofi has received US Food and Drug Administration (FDA) Fast Track Designation.
SAR’579/IPH6101 is a trifunctional anti-CD123 NKp46xCD16 natural killer (NK) cell engager used for the treatment of haematological malignancies. It was discovered, alongside SAR’514/IPH6401 (a trifunctional anti-BCMA NKp46×CD16 NK cell engager), as part of a 2016 collaboration between Innate Pharma and Sanofi, which used Innate Pharma’s ANKET platform to develop next-generation, multi-specific NK cell engagers.
Under the terms of the agreement, Sanofi is responsible for the development, manufacturing and commercialisation of any products resulting from the research collaboration. Innate Pharma will be eligible for up to €400m in development and commercial milestones, as well as royalty payments.
Mondher Mahjoubi, CEO of Innate Pharma, stated: “It is promising to see SAR’579/IPH6101 was granted Fast Track Designation in the US for the treatment of haematological malignancies, and [we] congratulate our partner Sanofi on this milestone. In addition to the encouraging clinical data recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, this FDA Fast Track Designation further validates the potential of the ANKET platform to treat cancer patients with NK cell engagers.”
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