Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA), a clinical-stage biotechnology company dedicated to developing innovative immunotherapies for cancer, has announced updated efficacy and safety results from the dose-escalation part of their Phase 1/2 study involving SAR443579/IPH6101 (SAR’579). This investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE) is the lead asset from Innate Pharma’s ANKET® platform and part of a joint research collaboration with Sanofi. These significant findings were presented at the European Hematology Association 2024 Congress in Madrid, Spain, on June 16.
Study Highlights and Objectives
The study, led by Sanofi, investigates SAR’579 as a monotherapy for treating blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), and high-risk myelodysplasia (HR-MDS). Notably, SAR’579 has received FDA Fast Track Designation for the treatment of acute myeloid leukemia.
Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma, expressed her optimism about the study’s progress: “We are pleased to see that SAR’579 continues to show promising and durable clinical efficacy along with a favorable safety profile. The ongoing Phase 1/2 study has recently progressed to the Phase 2 stage, marking a significant milestone in its development. We look forward to the continued progress of this multi-specific NK Cell Engager which holds great potential to benefit patients suffering from various blood cancers.”
Detailed Results
The study treated 59 patients (58 with R/R AML and 1 with HR-MDS) across 11 dose levels ranging from 0.01 to 6mg/kg. Patients had received a median of two prior lines of treatment (range 1–10). The highest response rate was observed at a final target dose of 1 mg/kg administered weekly, with five AML patients achieving complete responses (4 CR and 1 CRi). The median treatment duration was 7.9 weeks, with durable complete responses (>10 months) observed in three patients, two of whom remain on maintenance therapy. SAR’579 was well tolerated up to doses of 6 mg/kg per week, providing a strong basis for the recommended doses in the Phase 2 portion of the trial.
Peter Adamson, Global Development Head of Oncology at Sanofi, emphasized the importance of these findings: “We are excited about the emerging results from our development of SAR’579. Ongoing studies are focused on further demonstrating the potential of the NK cell engager in patients with leukemia. We look forward to sharing data from these trials at future scientific meetings.”
The ANKET® Platform
ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate Pharma’s proprietary platform, designed to develop next-generation, multi-specific natural killer (NK) cell engagers for treating various types of cancer. This platform represents a novel class of molecules aimed at inducing synthetic immunity against cancer.
Innate-Sanofi Collaboration
Innate Pharma’s collaboration with Sanofi began in 2016 and involves developing innovative multi-specific antibody formats that engage NK cells through the activating receptors NKp46 and CD16 to kill tumor cells. Sanofi is responsible for the development, manufacturing, and commercialization of the products resulting from this collaboration, including SAR443579/IPH6101 and SAR445514/IPH6401. Innate Pharma stands to receive up to €400 million in development and commercial milestone payments, as well as royalties on net sales.
Under a 2022 agreement, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. This agreement could bring Innate Pharma up to €1.35 billion in development and commercial milestone payments, along with royalties on net sales.
About Innate Pharma
Innate Pharma S.A., headquartered in Marseille, France, with a U.S. office in Rockville, MD, is a global leader in developing immunotherapies for cancer patients. Listed on Euronext Paris and Nasdaq, the company’s innovative approach focuses on harnessing the innate immune system through therapeutic antibodies and its ANKET® platform. Innate Pharma’s portfolio includes several promising programs, such as lacutamab for cutaneous T cell lymphomas, monalizumab for non-small cell lung cancer (in collaboration with AstraZeneca), and multi-specific NK cell engagers for various tumor types.
Innate Pharma continues to be a trusted partner to leading biopharmaceutical companies and research institutions, accelerating innovation and development to benefit patients worldwide.
Source: Innate Pharma