Regulatory Filings • Oct 30, 2012
Regulatory Filings
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A Phase I Study of an Anti-KIR Antibody in Combination With an Anti-PD1 Antibody in Patients With Advanced Solid Tumors
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 – IPH), the innate immunity company developing first-in-class drugs for cancer and inflammatory diseases, today announces that a Phase I trial sponsored by Bristol-Myers Squibb was published on the NIH website ClinicalTrials.gov for IPH2102/BMS-986015 and is currently recruiting* .
Marcel Rozencweig, Chief Medical Officer of Innate Pharma, said: "IPH2102/BMS-986015 will be tested in a variety of solid tumors, in combination with anti-PD-1 which has shown promising single agent results in Phase I/II trials."
The purpose of this Phase I open label study is to determine whether the combination of IPH2102/BMS-986015 and BMS-936558 is safe and provide preliminary information on the clinical activity of the combination.
The primary outcome will be safety. Secondary outcomes will include a preliminary assessment of efficacy, as measured by tumor assessment. It will be conducted in two parts - dose escalation and cohort expansion - and is expected to enroll approximately 150 patients, with up to 48 patients in dose escalation and up to 96 patients in cohort expansion. During dose escalation, patients with any advanced tumor type (with the exception of primary central system tumors and hematologic malignancies) will be eligible to enroll. During cohort expansion, tumor type will be restricted to the following advanced malignancies: non-small cell lung cancer – squamous and non-squamous histology, Renal Cell Carcinoma, Melanoma, Colorectal Cancer and Serous Ovarian Carcinoma.
IPH2102/BMS-986015 is a fully human monoclonal antibody blocking interaction between Killercell immunoglobulin-like receptors (KIR) on NK cells with their ligands. Blocking these receptors facilitates activation of NK cells and, potentially, destruction of tumor cells by the latter.
IPH2102/BMS-986015 is licensed to Bristol-Myers Squibb Company (NYSE:BMY). As part of the agreement between Innate Pharma and Bristol-Myers Squibb, Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture and commercialize IPH2102/BMS-986015 and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma will conduct the development of IPH2102/BMS-986015 through Phase II in acute myeloid leukemia. A randomized, double-blind, placebo-controlled Phase II trial assessing IPH2102/BMS-986015 is about to be initiated in elderly patients with acute myeloid leukemia in a maintenance setting.
* http://www.clinicaltrials.gov/ct2/show/NCT01714739?term=BMS-986015&rank=1
Anti-PD-1 is a fully-human antibody that targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1† .
Innate Pharma S.A. is a biopharmaceutical company developing first-in-class immunotherapy drugs for cancer and inflammatory diseases.
The Company specializes in the development of new monoclonal antibodies targeting receptors and pathways controlling the activation of innate immunity cells. Its innovative approach has been validated by licence agreements with two major pharmaceutical companies, Novo Nordisk A/S and Bristol-Myers Squibb.
Incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006, Innate Pharma is based in Marseilles, France, and had 81 employees as at June 30, 2012.
Learn more about Innate Pharma at www.innate-pharma.com.
Practical Information about Innate Pharma shares:
| ISIN code | FR0010331421 |
|---|---|
| Ticker code | IPH |
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.
For additional information, please contact:
Innate Pharma ATCG Press Laure-Hélène Mercier Director, Investor Relations Phone: +33 (0)4 30 30 30 87 Mob.: +33 (0)6 26 94 18 53 [email protected] [email protected]
Marielle Bricman
† For more information, please refer to: http://news.bms.com/press-release/financial-news/investigational-anti-pd-1 immunotherapy-bms-936558-showed-clinical-acti
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