June 17, 2024 – Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) has announced updates on the efficacy and safety results from the dose-escalation segment of their Phase 1/2 study featuring SAR443579/IPH6101 (SAR’579). This investigational drug, a CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), is being developed through a collaboration between Innate Pharma and Sanofi under the ANKET® platform. The findings were presented at the European Hematology Association 2024 Congress in Madrid on June 16.
The study, spearheaded by Sanofi, evaluates SAR’579 as a monotherapy for treating blood cancers with significant unmet needs, such as relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), and high-risk myelodysplasia (HR-MDS). SAR’579 has also received FDA Fast Track Designation for treating acute myeloid leukemia.
Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma, expressed optimism about the ongoing research. She noted that SAR’579 is showing promising clinical efficacy and a favorable safety profile. The ongoing Phase 1/2 study has advanced to Phase 2, marking a crucial development milestone. Dr. Quaratino looks forward to further progress, highlighting the potential benefits for patients with various blood cancers.
In the study, 59 patients (58 with R/R AML and 1 with HR-MDS) were treated across 11 different dose levels (ranging from 0.01 to 6 mg/kg). These patients had previously undergone a median of two prior treatments (ranging from 1 to 10). At a final target dose of 1 mg/kg weekly, a maximum response rate was observed, with five AML patients achieving a complete remission (4 complete remissions and 1 complete remission with incomplete hematological recovery). The median treatment duration was 7.9 weeks, with three patients experiencing durable complete remission (lasting over 10 months). Two patients remain on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg weekly, and these data will be used to determine recommended doses for the Phase 2 trial.
Peter Adamson, Global Development Head, Oncology at Sanofi, also expressed enthusiasm about the results and the potential of the NK cell engager in leukemia patients. He anticipates sharing further data from ongoing research in future scientific meetings.
The ANKET® platform (Antibody-based NK cell Engager Therapeutics) developed by Innate Pharma is designed to create next-generation, multi-specific NK cell engagers to treat certain cancers. This technology aims to induce synthetic immunity against cancer and represents a new class of therapeutic molecules.
Under a research collaboration and license agreement established in 2016, Sanofi is responsible for the development, manufacturing, and commercialization of products arising from the collaboration, including SAR443579/IPH6101 and SAR445514/IPH6401. Innate Pharma stands to receive up to €400m in development and commercial milestone payments as well as royalties on net sales.
A subsequent license agreement in December 2022 granted Sanofi the license for IPH62 and IPH67, with an option for an additional target. This agreement could yield up to €1.35bn for Innate Pharma in development and commercial milestone payments, plus royalties on net sales.
Innate Pharma S.A., based in Marseille, France, develops immunotherapies for cancer patients by leveraging the innate immune system through therapeutic antibodies and its ANKET® platform. The company collaborates with biopharmaceutical firms like Sanofi and AstraZeneca as well as leading research institutions to advance innovation and development for patient benefit.
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