On January 4, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies (Press release, Innate Pharma, JAN 4, 2021, View Source [SID1234573454]). IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019).

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In the first research program of the collaboration, IPH6101/SAR443579 has shown anti-tumor activity in pre-clinical models, including encouraging pharmacokinetic (PK), pharmacodynamic (PD) and safety data in preliminary non-human primate studies, as well as positive manufacturability properties, leading to its selection as a drug candidate for development.

The decision triggered a €7M milestone payment from Sanofi to Innate. Sanofi will be responsible for all future development, manufacturing and commercialization of IPH6101/SAR443579.

This milestone is part of the previously announced research collaboration with Sanofi, under which the companies collaborate on the generation and evaluation of up to two bispecific NKCEs, using technology from Innate and Sanofi’s proprietary bispecific antibody formats as well as tumor targets. The companies are also currently working on the second research program.

"We are very pleased that Sanofi will work to bring IPH6101/SAR443579 towards the clinic, as it highlights the potential of engaging NK cells through NKp46, as well as the robustness of Innate’s proprietary multi-specific antibody format," said Pr. Eric Vivier, PhD, Chief Scientific Officer at Innate Pharma. "We believe IPH6101/SAR443579 is the first NKp46-based NK cell engager to start development, demonstrating the next wave of scientific innovation at Innate. This successful validation will also be valuable for our second ongoing research program with Sanofi, and ultimately, the overall Innate NK cell engager platform."

Innate’s multifunctional NKCE technology is comprised of novel antibody formats that simultaneously target two activating receptors, NKp46 and CD16, on NK cells as well as a tumor antigen on cancer cells.

Such trifunctional NKCEs have proven more effective in pre-clinical models than classical antibodies directed against the same tumor target, as co-engagement of multiple surface receptors on NK cells is required for their full activation.

NKCEs may show improved therapeutic window for cancer treatment as compared to bispecific T lymphocyte-engaging formats.

About NKp46-based NKCE:
NKp46 is an activating receptor expressed on all NK cells. It is the most specific marker of human NK cells and plays a major role in their tumor cell recognition.

Innate’s NKp46 multi-specific NK cell engagers bind with one arm to an antigen at the surface of tumor cells, and with another arm to the NKp46 receptor on NK cells. This leads to activation and specific tumor-killing and cytokine secretion by NK cells, an immune cell population representing a significant proportion of all cytotoxic lymphocytes in the body.

About the Innate-Sanofi agreement:
The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multispecific antibody formats engaging natural killer (NK) cells to kill tumor cells and secrete cytokines through the activating receptor NKp46.

Under the terms of the licence agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.