ASCO 2016: Phase I study protocol investigating IPH4102 in cutaneous T-Cell lymphomas
05 Juin 2016 - 3:13PM
- Phase I study of IPH4102 in patients with
relapsed/refractory cutaneous T-cell lymphomas commenced in
November 2015 and continues on track in EU and US centers
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 -
IPH) today announces that Professor Martine Bagot, Head of the
Dermatology Department at the Saint-Louis Hospital in Paris
discussed the protocol of the ongoing first in human study of
IPH4102 in patients with relapsed/refractory cutaneous T-cell
lymphomas (CTCL) in a "Trial in progress" poster at the 2016
ASCO[1] annual meeting (June 3-7, 2016, in Chicago, USA).
The poster has been made available on the
Company's website, in the Product Pipeline - IPH4102 section.
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, United Kingdom) and in
the US. 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.
This trial is expected to deliver data for the
dose escalation and cohort expansion at the end of 2017 and 2018
respectively.
About IPH4102:
IPH4102 is a first-in-class anti-KIR3DL2
humanized cytotoxicity-inducing antibody, designed to trigger
killing of cutaneous T-cell lymphomas ("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 biopharmaceutical
company discovering and developing first-in-class therapeutic
antibodies for the treatment of cancer and inflammatory
diseases.
Innate Pharma specializes in immuno-oncology, a
new therapeutic field that is changing cancer treatment by
enhancing the capability of the body's own immune cells to
recognize and kill cancer cells.
The Company has pioneered the development of
antibodies that block inhibitory checkpoint receptors on NK cells.
Today, Innate Pharma has three first-in-class antibodies in
clinical development in immuno-oncology and a pipeline of
preclinical candidates to novel targets and mechanisms.
Its innovative approach has translated into
alliances with leaders in the biopharmaceutical industry such as
AstraZeneca, Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi.
Based in Marseille, France, Innate Pharma had
122 employees as at March 31, 2016. The company 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 |
[1] American Society of Clinical Oncology
asco 2016: Phase I study protocol investigating IPH4102 in CTCL
http://hugin.info/155662/R/2018058/748970.pdf
HUG#2018058
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