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.
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
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: INNATE PHARMA via Globenewswire
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