Partner MedImmune expands colorectal cancer patient cohort in ongoing PHASE I TRIAL EVALUATING MONALIZUMAB IN COMBINATION WITH IMFINZI® (DURVALUMAB)
- Additional expansion cohorts to explore the safety and efficacy of monalizumab in combination with durvalumab and standard of care in patients with 1st- and 2nd line, metastatic colorectal cancer (CRC)
Marseille, France, March 23, 2018, 7:00 AM CET
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) today announces that its partner MedImmune, AstraZeneca's global biologics research and development arm, has amended the clinical trial protocol of the ongoing Phase I trial investigating the safety and efficacy of monalizumab, Innate's investigational first-in-class anti-NKG2A monoclonal antibody, in combination with AstraZeneca's approved anti-PD-L1 immune checkpoint inhibitor, durvalumab, in patients with advanced solid tumors. The trial protocol has been expanded to add new expansion cohorts aiming at testing monalizumab in combination with durvalumab and standard of care in patients with 1st- and 2nd-line, metastatic colorectal cancer (CRC).
The dose-escalating part of the study has been completed, while the expansion cohorts in selected advanced solid tumors are ongoing.
The primary objective of the new study arms will be safety, with Overall Response Rate (ORR) and Duration of Response (DOR), amongst others, as secondary outcome measures.
Pierre Dodion, Chief Medical Officer of Innate Pharma, commented: "We are delighted that our partner MedImmune has decided to further expand the colorectal patient population to evaluate the safety and efficacy of monalizumab in combination with durvalumab and the current standard of care in 1st- and 2nd-line therapy. In addition, we look forward to the first clinical data read-outs from the Phase I study and initial expansion cohort program during 2018."
An update to study D419NC00001 including the new additional study arms has been published on clinicaltrials.gov.
Monalizumab is a first-in-class antibody targeting NKG2A receptors expressed on tumor infiltrating cytotoxic NK and CD8 T lymphocytes.
NKG2A is an inhibitory checkpoint receptor binding HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently up-regulated on cancer cells of many solid tumors or hematological malignancies. Hence, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies.
Monalizumab is partnered with AstraZeneca and MedImmune, AstraZeneca's global biologics research and development arm, through a co-development and commercialization agreement. A broad exploratory joint clinical development program is ongoing, focused on investigating monalizumab in combination strategies.
Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
As part of a broad development programme, durvalumab is also being investigated as a monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, as a first line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumors.
Colorectal cancer is the 3rd most commonly diagnosed cancer, with 1.65 million new cases and 835,000 deaths per year worldwide (WHO, GLOBOCAN database, 2015). 21% of colorectal cancer cases are metastatic at diagnosis, but given that some patients who are diagnosed with local disease at some point progress, the total number of patients with metastatic disease may account for roughly 50% of all colorectal cancer patients.
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 innate immunity.
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 four 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
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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.
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