Sanofi Terminates CD123 ANKET® Collaboration with Innate Pharma and Announces Intent to Make €15M Strategic Investment

On April 23, biopharmaceutical company Innate Pharma announced that it has regained global rights to its CD123-targeted ANKET® (Antibody-based NK cell Engager Therapeutics) drug SAR’579/IPH6101, which is currently in the development stage for the treatment of acute myeloid leukemia (AML). Meanwhile,Sanofi also intends to make a strategic equity investment of up to 15 million euros in Innate Pharma.

According to the announcement released by Innate Pharma, the company and Sanofi jointly reviewed the research collaboration and license agreement signed in 2016. In line with the adjustment of their current strategic priorities, Sanofi has decided to continue advancing the development of SAR’514/IPH6401 (BCMA ANKET®) in the field of autoimmune diseases. Meanwhile,Sanofi and Innate Pharma Reach Agreement to Terminate 2016 Collaboration on SAR’579/IPH6101 (CD123 ANKET®). This Means Innate Pharma Will Regain Full Rights to This CD123-Targeted ANKET® Drug.

The Phase 1/2 clinical study (NCT05086315) of SAR’579 / IPH6101, previously led by Sanofi, is still ongoing. Efficacy and safety data from the dose-escalation portion, presented at the 2024 European Hematology Association (EHA) Congress, showed that SAR’579 demonstrated clinical benefit and durable responses in patients with relapsed or refractory AML.At a dose of 1 mg/kg, five complete responses were observed (4 CRs, 1 CRi), with 3 patients having a CR duration exceeding 10 months.In April 2024, Sanofi advanced SAR’579 / IPH6101 to the initial dose expansion phase of the trial. Both parties will develop a transition plan for the ongoing study.

Another highlight of this announcement isSanofi intends to make a new stock investment of up to 15 million euros in Innate Pharma.The scale and price of this potential investment will be determined based on current market conditions and will proceed if market conditions are met. Jonathan Dickinson, CEO of Innate Pharma, welcomed the move, stating it would further validate the company’s innovation and scientific progress in R&D. He also noted that Innate Pharma will continue to evaluate, plan, and execute its proprietary ANKET® programs in oncology and other fields.

Despite the termination of the CD123 ANKET® collaboration, Sanofi will continue to focus on the development of SAR’514/IPH6401 (BCMA ANKET®) in the field of autoimmune diseases under the 2016 licensing agreement.The Sanofi-led Phase 1/2 clinical study (NCT05839626) in patients with relapsed or refractory multiple myeloma will be terminated early to refocus the program on autoimmune diseases.

ANKET® is Innate Pharma's proprietary antibody-based Natural Killer (NK) cell engager technology platform. As early as 2016, Sanofi and Innate Pharma reached a research collaboration and licensing agreement to jointly develop innovative bispecific NK cell engagers based on Innate Pharma’s technology and Sanofi’s oncology targets.According to the agreement at that time, Innate Pharma was eligible to receive up to 400 million euros in milestone payments as well as royalties on net sales.

NKp46 is an activating receptor expressed on all NK cells and is the most specific marker of human NK cells, playing a crucial role in the recognition of tumor cells by NK cells. The ANKET® technology activates NK cells and specifically kills tumor cells by binding one arm to antigens on the surface of tumor cells and the other arm to the NKp46 receptor on NK cells.

In addition, Innate Pharma's another NK cell engager project IPH62 (targeting B7-H3) based on the ANKET® platform is also under development. After completing the research collaboration period and identifying the lead candidate, Sanofi will be responsible for all its development, manufacturing, and commercialization. Sanofi still retains the right to select an additional ANKET® target under the 2022 Research Collaboration and License Agreement. The Research Collaboration and License Agreement reached by both parties in 2022 remains unchanged.Innate Pharma is still eligible for more than 1 billion euros in R&D and commercial milestone payments.

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