INNATE PHARMA: Preliminary safety and clinical activity results for IPH4102 to be presented at the Third World Congress of Cu...
13 Octobre 2016 - 5:41PM
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.
About IPH4102:
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:
ISIN
code Ticker code |
FR0010331421 IPH |
Disclaimer:
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 |
Laure-Hélène Mercier Director,
Investor Relations |
ATCG
Press (France) Marie Puvieux |
Tel.: +33 (0)4 30 30 30 87 |
Mob: +33
(0)6 10 54 36 72 |
investors@innate-pharma.com |
presse@atcg-partners.com |
|
Consilium Strategic Communications (ROW) |
|
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Hendrik
Thys |
|
Tel.: +44 (0)20 3709 5700 |
|
InnatePharma@consilium-comms.com |
PR in English http://hugin.info/155662/R/2048907/766138.pdf
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