INNATE PHARMA : first patient in the Phase I study of IPH5401 in combination with durvalumab
Innate PHARMA announces enrollment of first patient in the phase i study of IPH5401 in combination with durvalumab (IMFINZI®) in solid tumors
-- IPH5401 is a first-in-class antibody targeting the C5a receptor expressed on subsets of myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment -- IPH5401 combined with PD-1/PD-L1 blockade represents a novel combination approach in immuno-oncology
Marseille, France, September 12, 2018, 07:00 AM CEST
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 - IPH today announced that the first patient has been enrolled in the Phase I dose escalation and expansion study (STELLAR-001[*]) evaluating IPH5401 in combination with durvalumab (Imfinzi®), an anti-PD-L1 immune checkpoint inhibitor, for the treatment of patients with solid tumors, including non-small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC).
“We are pleased to have started the first clinical study for IPH5401,” commented Pierre Dodion, Chief Medical Officer of Innate Pharma. “Despite significant recent advances in immunotherapy, immune escape of tumor cells remains a major challenge. We believe that IPH5401 has a high potential for cancer patients in multiple indications and could play an important role in PD-1/PD-L1 combination strategies for patients who are non-responsive, have a poor response or who have stopped responding to PD-1/PD-L1 immunotherapies.”
Both durvalumab and IPH5401 are cancer immunotherapies, a potent class of treatments that use the body’s own immune system to help fight cancer. Durvalumab blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors (CRI-CIMT-EATI-AACR ICI 2017, poster #B184). Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.
The two-part study design includes an initial dose escalation phase to explore three doses of IPH5401 in combination with durvalumab in selected solid tumors. The first cohort will include a two-week run-in period evaluating the safety of IPH5401 prior to performing the combination dosing. At the highest dose of IPH5401, two dosing schedules will be evaluated. The recommended dosing regimen will then be used in the subsequent expansion part of the study in NSCLC with secondary resistance to IO and IO-naïve HCC; both tumors constitute patient populations with a high unmet medical need.
In January 2018, Innate Pharma and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a non-exclusive clinical trial collaboration to evaluate the combination of IPH5401 and durvalumab in a Phase I study for patients with selected solid tumors. The study is conducted by Innate and the costs are equally shared by both parties.
Clinical trial sites are located in France and the US. For more information on the STELLAR-001 clinical study (NCT03665129), please visit clinicaltrials.gov.
IPH5401 is a first-in-class therapeutic antibody that specifically binds and blocks C5a receptors (C5aR) expressed on subsets of myeloid-derived suppressor cells (MDSC) and neutrophils. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory and angiogenic factors, and they potently suppress anti-tumor T and NK cells, and hamper the activities of PD-1 checkpoint blockers.
C5a, a factor in the complement cascade, is often overexpressed in tumors, where it attracts and activates MDSC and neutrophils in the tumor microenvironment. Preliminary evidence suggests high expression of the C5a receptor in both NSCLC and HCC.
Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response.
As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.
About Innate Pharma:
Innate Pharma S.A. is a clinical-stage biotechnology company dedicated to improving cancer treatment and clinical outcomes for patients through first-in-class therapeutic antibodies that harness the body’s own immune system.
Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body’s immune system to recognize and kill cancer cells.
The company’s broad pipeline includes several first-in-class clinical stage antibodies as well as preclinical candidates and technologies that have the potential to address a broad range of cancer indications with high unmet medical needs.
Innate Pharma has pioneered the discovery and development of checkpoint inhibitors, with a unique expertise and understanding of Natural Killer cell biology. This innovative approach has resulted in major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi. Innate Pharma is building the foundations to become a fully-integrated biopharmaceutical company.
Based in Marseille, France, Innate Pharma has more than 180 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com
Information about Innate Pharma shares:
ISIN code FR0010331421 Ticker code IPH LEI 9695002Y8420ZB8HJE29
This press release contains certain 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. For a 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 Document de Reference prospectus filed with the AMF, which is available on the AMF website ( http://www.amf-france.org ) or on Innate Pharma’s website.
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
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[*] STELLAR = SelecTivE bLocking of compLement receptor C5AR to boost immune response and improve cancer outcomes
-- PR in English.pdf