First patient dosed in SAR’514 / IPH6401 Phase 1/2 clinical trial in relapsed/refractory multiple myeloma

• Partner Sanofi advances SAR’514 / IPH6401, a trifunctional anti-BCMA NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, to first-in-human clinical trial in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

• Second molecule from Innate’s multi-specific NK cell engager platform ANKET^® to progress to the clinic

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626), evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)¹.

SAR’514 is a trifunctional anti-BCMA NKp46xCD16 NK cell engager, using Sanofi’s proprietary CROSSODILE^® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform. 

The purpose of the dose escalation and dose expansion study is to evaluate the safety, pharmacokinetics and preliminary efficacy of SAR’514 in monotherapy in patients with RRMM and RRLCA. 

Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer at Innate Pharma “We are pleased to see a second molecule from our ANKET® platform reaching the clinic. In addition to the targeting of the tumor antigen BCMA, SAR’514 / IPH6401 co-engages the two activating receptors NKp46 and CD16 to leverage the advantages of harnessing NK cell effector functions against cancer cells and thus has the potential to be a new innovative option for patients living with Relapsed/Refractory Multiple Myeloma or Light-chain Amyloidosis.”

Peter Adamson, MD, Global Development Head, Oncology, Sanofi “We are excited to see our collaboration with Innate Pharma continue to move forward, leveraging scientific advances in our understanding of the potential of NK cells to impact cancer. Our first patient dosed with SAR’514 / IPH6401 is indeed welcome news. We look forward to data as it emerges, with the goal of improving the outcome for patients with relapsed/refractory multiple myeloma (RRMM) or relapsed/refractory light-chain amyloidosis (RRLCA).”

The start of the trial has triggered a milestone payment from Sanofi to Innate, which is part of a previously announced research collaboration with Sanofi. 

More information about the Phase 1/2 trial can be found on clinicaltrials.gov.

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.

About the Innate-Sanofi agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes IPH6101/SAR’579 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and IPH6401/SAR’514 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

Another license agreement was entered in December 2022, which includes IPH62 and 2 options.

_{1 Amyloidosis is a disease linked to the accumulation in various organs and tissues of deposits of amyloid substance made up of monoclonal light chains forming insoluble fibrils. These deposits progressively impair the functioning of the affected organs and tissues. 
Up to 30% of patients with multiple myeloma have coexisting subclinical primary amyloidosis (Rajkumar SV, Gertz MA, Kyle RA. Primary systemic amyloidosis with delayed progression to multiple myeloma. Cancer. 1998;82:1501–5).}