SAR443579/IPH6101, the most advanced drug candidate on the ANKET® platform, is a first-in-class NK Cell Engager engaging NKp46/CD16 receptors and targeting CD123, resulting from a collaboration agreement between Innate Pharma and Sanofi, under development by Sanofi in relapsed/refractory acute myelogenous leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplastic syndrome SAR443579/IPH6101 continues to show clinical benefit, durable responses as well as a safety profile. favorable tolerance in patients with relapsed/refractory acute myeloid leukemia. Five complete remissions (4 CR / 1 RCi) were obtained at a dose of 1 mg/kg and lasting complete remissions (>10 months) were observed in 3 patients.
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“ Innate » or the “ Company “) today announced new efficacy and safety results from a Phase 1/2 dose escalation study with SAR443579/IPH6101 (SAR’579), a NK Cell Engage targeting CD123 and co-engaging NKp46 and CD16 receptors, under development, from a collaboration between Innate Pharma and Sanofi, were presented during an oral presentation at the annual congress of the European Hematology Association1 (EHA) 2024 in Madrid, Sunday June 16 at 11:45 a.m.
The study, led by Sanofi, is evaluating SAR’579 as a monotherapy for the treatment of hematologic cancers with high medical need, including relapsed/refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (ALL -B), or high-risk myelodysplastic syndrome (HR-MDS). SAR443579 Received Fast Track Status from the Food and Drug Administration2 (FDA) for the treatment of acute myeloid leukemia.
“ We are pleased to see that SAR’579 continues to show promising and durable clinical efficacy and a favorable safety profile. The ongoing Phase 1/2 study recently progressed to Phase 2, marking an important milestone in its development. We look forward to the continued development of this multi-specific NK cell engager which has significant potential for patients suffering from various blood cancers,” commented on Dr. Sonia Quaratino, Medical Director of Innate Pharma.
Fifty-nine patients (58 R/R AML and 1 HR-MDS) distributed over 11 dose levels, from 0.01 to 6 mg/kg, were treated. Patients received a median of 2 (1 – 10) prior lines of therapy. A maximum response rate was observed at a final target dose of 1 mg/kg weekly, with 5 AML patients achieving CR (4 CR/1 CRi)3. The median duration of treatment was 7.9 weeks, with a durable CR (>10 months) observed in 3 patients, 2 of whom were still on treatment at the data date. SAR’579 was well tolerated up to weekly doses of 6 mg/kg. These data will make it possible to define the recommended doses for Phase 2 of the trial.
“ We are very pleased with the first results observed in the development of SAR’579. Ongoing studies aim to better demonstrate the potential of this NK cell engagement in patients with leukemia. We look forward to sharing data from these trials at future scientific conferences, » declares Peter Adamson, Director of Global Oncology Development, Sanofi.
About ANKET® :
ANKET® (HASntibody-based N.K. cell Eengage Ttherapeutics) is Innate Pharma’s proprietary platform enabling the development of a new generation of NK cell engages multi-specific to treat certain types of cancer.
This versatile technology makes it possible to create an entire new class of molecules inducing synthetic immunity against cancer.
About the Sanofi/Innate collaboration and licensing agreement:
Innate has a collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of multi-specific antibodies that engage NK cells via the activating receptors NKp46 and CD16 to eliminate tumor cells.
According to the terms of the 2016 collaboration and licensing agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the collaboration, which includes SAR443579/IPH6101 (targeting CD123) and SAR445514/IPH6401 (targeting BCMA). Innate is eligible for milestone payments linked to the achievement of development and marketing objectives of up to €400 million as well as royalties based on net sales.
According to the terms of thecollaboration and license agreement concluded in December 2022, comprising IPH62 (targeting B7-H3), IPH67 and an option on an additional target, Innate is eligible for milestone payments of up to €1.35 billion linked to the achievement of preclinical objectives , clinical, regulatory and commercial as well as royalties on potential net sales.
About Innate Pharma:
Innate Pharma SA is a clinical-stage biotechnology company developing immunotherapy treatments against cancer. Its innovative approach aims to take advantage of the innate immune system through therapeutic antibodies and its proprietary ANKET platform.® (HASntibody-based N.K. cell Eengage Ttherapeutics).
Innate’s portfolio includes the proprietary lacutamab program, developed in advanced forms of cutaneous T-cell lymphomas and peripheral T-cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as multi-specific antibodies involving NK cells from its ANKET platform® and can target different types of cancers.
To accelerate innovation, research and development of treatments to benefit patients, Innate Pharma is a trusted partner for leading biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions.
Based in Marseille, with a subsidiary in Rockville (Maryland, United States), Innate Pharma is listed on the Euronext Paris stock exchange and on the Nasdaq in the United States.
Find Innate Pharma on www.innate-pharma.com and follow our news on LinkedIn And X.
Useful information :
| ISIN code | FR0010331421 | |
| Mnemonic code | Euronext: IPH Nasdaq: IPHA | |
| LEI | 9695002Y8420ZB8HJE29 |
Disclaimer regarding forward-looking information and risk factors:
This press release contains forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain terms, including “believe”, “potential”, “expect” and “will” and other similar expressions, are intended to identify forward-looking statements. Although the Company considers that its projections are based on reasonable assumptions, these forward-looking statements may be affected by a number of risks and uncertainties, which could result in results materially different from those anticipated. These risks and uncertainties include, in particular, the uncertainties inherent in research and development, including those relating to safety, progress and results of ongoing or planned clinical trials and preclinical studies, reviews and authorizations from regulatory authorities concerning the Company’s product candidates, the Company’s commercial efforts, the Company’s ability to continue to raise funds for its development. For additional considerations regarding risks and uncertainties that could cause the actual results, financial position, performance and achievements of the Company to differ, please refer to the “Risk Factors” section of the Universal Registration Document filed with the Financial Markets Authority (AMF), available on the Innate Pharma websites (www.innate-pharma.com) and the AMF (www.amf-france.org), and public documents and reports filed with the United States Securities and Exchange Commission (SEC), including the annual report on “Form 20-F” for the year ended December 31, 2023 and documents and reports subsequent documents filed with the AMF or the SEC, or otherwise made public, by the Company.
This press release, and the information it contains, constitute neither an offer to sell or subscribe, nor the solicitation of an order to purchase or subscribe, for Innate Pharma shares in any country.
1 European Hematology Association
2 US Medicines Agency
3 CR: complete remission; RCi complete remission with incomplete hematological recovery
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