Innate Pharma Shares Updated Results From the Sanofi Developed Blood Cancer Phase 1/2 SAR443579/IPH6101 Trial
Innate Pharma's Phase 1/2 trial of SAR443579 (SAR’579), developed with Sanofi, continues to show promising results for treating relapsed/refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), and high-risk myelodysplasia (HR-MDS). The clinical trial results, presented at the European Hematology Association 2024 Congress, highlight 5 complete remissions at a 1 mg/kg dose, with 3 patients achieving durable CR over 10 months. SAR’579 has an FDA Fast Track Designation for acute myeloid leukemia and has shown a favorable safety profile at doses up to 6 mg/kg weekly. The study has now progressed to Phase 2, focusing on further demonstrating the efficacy of this NK cell engager.
- SAR’579 shows 5 complete remissions in R/R AML patients at 1 mg/kg dose.
- Three patients achieved durable complete remissions exceeding 10 months.
- FDA Fast Track Designation for acute myeloid leukemia.
- SAR’579 well tolerated at doses up to 6 mg/kg weekly.
- Study progressed to Phase 2, indicating promising development.
- Median treatment duration is relatively short at 7.9 weeks.
- Only 1 HR-MDS patient included in the study.
- number of complete remissions relative to the total patient pool.
Insights
The updated results from the Phase 1/2 study of SAR443579/IPH6101, particularly in patients with relapsed or refractory acute myeloid leukemia (R/R AML), are noteworthy. Achieving complete remissions (CR) in five patients, with three exhibiting durable responses greater than 10 months, indicates a promising efficacy profile for this NK cell engager. The NKp46/CD16-based mechanism targeting CD123 is innovative, potentially introducing a new class of immunotherapies in hematologic malignancies. Given that acute myeloid leukemia often has limited treatment options and a poor prognosis, these results are significant in demonstrating potential long-term benefits for patients. The favorable safety profile, with tolerability up to 6 mg/kg, further supports the therapeutic potential of SAR443579/IPH6101, suggesting it could be a well-tolerated option in a heavily pretreated patient population where adverse effects can sometimes limit therapy.
Additionally, the FDA Fast Track Designation for the treatment of acute myeloid leukemia emphasizes the high unmet medical need and the potential of this drug to expedite the development and review process, providing patients access to promising new treatments more quickly.
Rating: 1From a financial perspective, these promising Phase 1/2 results for SAR443579/IPH6101 could have a substantial positive impact on Innate Pharma's valuation. Clinical successes in the biotech industry, particularly those involving novel mechanisms of action like NK cell engagers, can lead to increased investor confidence and potential strategic partnerships. The progression of this investigational drug to Phase 2 marks a significant milestone, potentially leading to future funding opportunities and licensing deals.
Moreover, Innate Pharma stands to benefit from the collaboration with Sanofi, a prominent player in the pharmaceutical industry. This partnership not only enhances the credibility of Innate's research but also mitigates financial risks associated with the high costs of drug development. The favorable safety and efficacy data, combined with durable response rates, position the company well for further development stages and potential commercialization, which can attract significant market interest.
Rating: 1The market implications for SAR443579/IPH6101 are worth noting. Targeting CD123, an antigen present on leukemia cells, makes this NK cell engager particularly relevant in a market with high unmet needs. The demonstrated clinical benefits in R/R AML patients, coupled with the drug’s favorable safety profile, suggest strong future market adoption potential. The incidence of AML and the limited number of effective therapies underscore the demand for innovative treatments.
Furthermore, obtaining durable complete remissions is a compelling outcome. Treatments that can achieve sustained remission offer substantial improvements in quality of life and survival rates for patients, which can drive market penetration. The FDA Fast Track Designation provides an added advantage, potentially accelerating the time to market and offering Innate Pharma a competitive edge in the oncology market.
Rating: 1
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SAR443579 /IPH6101, ANKET® platform lead asset, is a first-in-class NKp46/CD16-based NK cell engager targeting CD123 from a joint research collaboration between Innate Pharma and Sanofi, under development by Sanofi in R/R AML, B-ALL and HR-MDS
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SAR443579 /IPH6101 continues to show clinical benefit and durable responses along with a favorable safety profile in patients with R/R AML, with 5 complete remissions (4 CR / 1 CRi) achieved at 1 mg/kg, with durable CR (>10 months) observed in 3 patients
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced today that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with
The study, led by Sanofi, tests SAR’579 as a monotherapy for the treatment of 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). SAR’579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia.
“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,” says Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.
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.
“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,” says Peter Adamson, Global Development Head, Oncology, Sanofi.
About ANKET®
ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.
About the Innate-Sanofi research collaboration and licensing agreements
The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.
Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes
As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.
Headquartered in
Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.
Information about Innate Pharma shares
ISIN code |
FR0010331421 |
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Ticker code |
Euronext: IPH Nasdaq: IPHA |
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LEI |
9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking information and risk factors
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the
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1 CR: complete remission; CRi: CR with incomplete hematological recovery
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Investors
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Henry Wheeler
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Henry.wheeler@innate-pharma.fr
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Source: Innate Pharma SA
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