PRELIMINARY SAFETY AND CLINICAL ACTIVITY RESULTS FOR IPH4102 TO BE PRESENTED AT THE THIRD WORLD CONGRESS OF CUTANEOUS LYMPHOMAS
Marseille, France, October 13, 2016
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH), today announces that preliminary safety and clinical activity results for the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas ("CTCL") will be presented by Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital, Paris, at the Third World Congress of Cutaneous Lymphomas "3WCCL" (October 26-28, 2016, in New-York, USA).
The presentation will be made available on the Company's website, in the Product Pipeline - IPH4102 section after the session.
About the presentation:
Title: " First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary safety and clinical activity results "
Scientific Session O. Therapeutics 3a:
Endpoints & Clinical Trials
Date: October 28, 2016
Presentaton Time: 13:30 - 14:45 EST
Presenter: Pr. Martine Bagot, Head of the Dermatology Department, Saint-Louis Hospital, Paris
Location: Roone Arledge Auditorium - Alfred Lerner Hall at Columbia University - New York
About IPH4102 Phase I trial:
The Phase I trial is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands, and United Kingdom) and in the US (NCT02593045). Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Netherlands), and the Guy's and St Thomas' Hospital (United Kingdom). Approximately 60 patients with KIR3DL2-positive CTCL having received at least two prior lines of systemic therapy are expected to be enrolled in two sequential study parts:
- A dose-escalation part including approximately 40 CTCL patients in 10 dose levels. Its objective is to identify the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D); the dose-escalation follows an accelerated 3+3 design;
- A cohort expansion part with 2 cohorts of 10 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) receiving IPH4102 at the RP2D until progression. Cohort design (CTCL subtype, number of patients.) may be revisited based on the findings in the dose escalation part of the study.
The primary objective of this trial is to evaluate the safety and tolerability of repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug's antitumor activity. A large set of exploratory analyses aims at identifying biomarkers of clinical activity. Clinical endpoints include overall objective response rate, response duration and progression-free survival.
IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed to trigger killing of CTCL cancer cells, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few therapeutic options at advanced stages.
KIR3DL2 is an inhibitory receptor of the KIR family, specifically expressed on all subtypes of CTCL and has a restricted expression on normal tissues. Potent antitumor properties of IPH4102 were shown against human CTCL cells in vitro and in vivo in a mouse model of KIR3DL2+ tumors, in which IPH4102 reduced tumor growth and improved survival. The efficacy of IPH4102 was further evaluated in laboratory assays using the patients' own natural killer (NK) cells against their primary tumor samples in the presence of IPH4102. These studies were performed in patients with Sézary Syndrome; Sézary Syndrome is the leukemic form of CTCL and is known to have a very poor prognosis. In these experiments, IPH4102 selectively and efficiently induced killing of the patients' CTCL cells. These results were published in Cancer Research in 2014 ( http://www.ncbi.nlm.nih.gov/pubmed/25361998 ).
IPH4102 was granted orphan drug status in the European Union for the treatment of CTCL.
About Innate Pharma:
Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients.
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 aim is to become a commercial stage biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases.
The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb and Sanofi.
Based in Marseille, France, Innate Pharma has more than 130 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com .
Practical Information about Innate Pharma shares:
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||Press Contacts|
Director, Investor Relations
ATCG Press (France)
|Tel.: +33 (0)4 30 30 30 87||Mob: +33 (0)6 10 54 36 72|
|Consilium Strategic Communications (ROW)|
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Hendrik Thys
|Tel.: +44 (0)20 3709 5700|
Last updated on: 14/10/2016
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