Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 115

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 115
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 Analysis of the CD123 NK Cell Engager SAR’579/IPH6101 in patients with relapsed or refractory AML, B-ALL or HR-MDS was presented at the ESMO congress.

▪ In December 2023, updated efficacy and safety results were shared in a poster presentation at the ASH Annual Meeting. Abstract details included:

• As of July 5, 2023, 43 patients (42 R/R AML and one HR-MDS) across eight dose levels at 10 - 6000 μg/kg/dose were included. Patients had received a median of 2.0 (1.0 - 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax.

• In dose levels with a highest dose of 1000 μg/kg QW, 5 out of 15 (33.3%) AML patients achieved a complete remission, or CR, (4 CRs and 1 CR with incomplete hematological recovery) as of the cut-off date.

• Data from preliminary pharmacokinetics / pharmacodynamic and in vitro mechanistic analyses studying dose-response relations were also presented.

• SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile.

Updated efficacy and safety results were presented at the European Hematology Association 2024

• Fifty-nine patients (58 R/R AML and 1 HR-MDS) across 11 dose levels (0.01 - 6mg/kg) were treated. Patients had received a median of 2 (1 - 10) prior lines of treatment. A maximum response rate was observed at a final target dose of 1 mg/kg every week with 5 AML patients achieving a CR (4 CR/1 CRi)1. The median treatment duration was 7.9 weeks, with durable CR (>10 months) observed in 3 patients with 2 remaining on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg every week. These data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial.

In April 2024, Sanofi advanced SAR’579 / IPH6101 to the Phase