IPH6101/SAR'579 (SAR443579) is the first NKp46/CD16-based NK cell engager (NKCE) utilizing Innate's proprietary multispecific antibody platform, ANKET® (Antibody-based NK cell Engager Therapeutics). This drug is part of a research collaboration and licensing agreement with Sanofi, established in 2016, focusing on developing innovative multispecific antibody formats that engage NK cells through NKp46 and CD16 to target tumor cells. 

Data from the Phase I/II study, presented at EHA 2024, showed SAR'579 continues to exhibit promising and durable clinical efficacy with a favorable safety profile. In the ongoing study, which has now progressed to Phase II, 59 patients (58 with relapsed/refractory acute myeloid leukemia [R/R AML] and 1 with higher-risk myelodysplastic neoplasms [HR-MDS]) were treated across 11 dose levels (0.01 – 6 mg/kg). These patients had a median of two prior treatments (ranging from 1 to 10). 

The highest response rate was observed at a dose of 1 mg/kg weekly, with five AML patients achieving complete remission (4 CR and 1 CRi). The median treatment duration was 7.9 weeks, with three patients experiencing durable complete remissions lasting over 10 months, and two remaining on maintenance therapy at the data cutoff. SAR'579 was well tolerated at doses up to 6 mg/kg weekly. 

Conclusion

SAR’579, developed by Innate Pharma and Sanofi, is the leading drug candidate for the ANKET platform. In June 2023, SAR'579 received US FDA’s Fast Track Designation (FTD) for the treatment of AML. Results presented at EHA 2024 demonstrated ongoing clinical benefits, durable responses, and a favorable safety profile in patients with relapsed/refractory AML. These findings will guide the selection of recommended doses for further development in the Phase II portion of the trial.