IPH4102: Completion of THE dose
escalation PART OF THE PHASE I TRIAL -DATA TO BE
PRESENTED AT International Conference on Malignant Lymphoma IN JUNE
2017 IN LUGANO
- Complete safety results and updated clinical activity data
will be presented at the ICML 2017 in Lugano in June;
- Preparation for cohort expansion part is ongoing.
Marseille, France, May 22, 2017, 7:00 AM
CEST
Innate Pharma SA (the "Company" - Euronext
Paris: FR0010331421 - IPH) today announced that it has completed
the dose escalation part of its ongoing Phase I trial evaluating
IPH4102 in patients with relapsed/refractory cutaneous T cell
lymphomas. No dose-limiting toxicity was reported and the maximum
tolerated dose (MTD) was not reached.
Full dose-escalation safety results, as well as
updated clinical activity data, will be disclosed in an oral
presentation at the upcoming International Conference on Malignant
Lymphoma (ICML), in Lugano, Switzerland on June 14 at 5:30 pm.
The abstract entitled "Phase I study of IPH4102,
anti-KIR3DL2 mab, in relapsed/refractory cutaneous t-cell lymphomas
(CTCL): dose-escalation safety, biomarker and clinical activity
results" will be available on the ICML online abstract book on June
7.
The cohort expansion part of the trial in
patients with transformed mycosis fungoides and Sézary syndrome,
with two cohorts of 15 patients, each receiving IPH4102 at the
recommended Phase II dose (RP2D) until progression, will start in
the upcoming weeks.
Pierre Dodion, Chief Medical Officer of
Innate Pharma, commented: "Although CTCL is an orphan disease,
the trial has progressed quickly. We are excited by the promising
safety profile and efficacy signals of our antibody in this
particularly difficult to treat disease. We look forward to the
feedback of regulatory authorities on those data and meanwhile are
working on the cohort expansion part of the trial which will start
shortly."
About IPH4102 Phase I trial:
The Phase I trial (NCT02593045) 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. 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 (Leiden, Netherlands),
and the Guy's and St Thomas' Hospital (London, United Kingdom).
55 patients with advanced CTCL having received at least two
prior lines of systemic therapy have been and will be enrolled in
two sequential study parts:
- The dose-escalation part has accrued 25 KIR3DL2-positive CTCL
patients in 10 dose levels. The objective was to characterize
IPH4102 safety profile, identify the MTD and/or the RP2D; the
dose-escalation followed an accelerated 3+3 design. Preliminary
safety and clinical activity results for the first seven dose
levels from the dose-escalation part were presented at the 3WCCL[*]
and ASH[*] in 2016;
- The cohort expansion part will have 2 cohorts of 15 patients
each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary
syndrome) receiving IPH4102 at the RP2D until progression.
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.
Clinical endpoints include global objective response rate, response
duration and progression-free survival. A large set of exploratory
analyses is aimed at identifying biomarkers of clinical
activity.
About IPH4102:
IPH4102 is a first-in-class anti-KIR3DL2
humanized cytotoxicity-inducing antibody, designed for treatment of
CTCL, 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, expressed by approximately 65% of patients across all CTCL
subtypes and expressed by up to 85% of them with certain aggressive
CTCL subtypes, in particular, Sézary Syndrome and transformed
mycosis fungoides. It has a restricted expression on normal
tissues.
IPH4102 was granted orphan drug status in
the European Union for the treatment of CTCL.
About Cutaneous T-Cell Lymphoma
("CTCL"):
CTCL is a heterogeneous group of non-Hodgkin's
lymphomas which arise primarily in the skin and are characterized
by the presence of malignant clonal mature T-cells. CTCL accounts
for approximately 4% of all non-Hodgkin's lymphoma cases and has a
median age at diagnosis of 55-65 years.
Mycosis fungoides, and Sézary Syndrome, its
leukemic variant, are the most common CTCL subtypes. The overall
5-year survival rate, which depends in part on disease subtype, is
approximately 10% for Sézary Syndrome and less than 15% for
transformed mycosis fungoides. CTCL is an orphan disease and
patients with advanced CTCL have a poor prognosis with few
therapeutic options and no standard of care. There are
approximately 6,000 new CTCL cases in Europe and the United States
per year.
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
fully-integrated 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 170 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at
www.innate-pharma.com.
Information about Innate Pharma
shares:
ISIN
codeTicker code |
FR0010331421IPH |
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 Laure-Hélène Mercier Chief Financial
Officer Tel.: +33 (0)4 30 30 30 87
investors@innate-pharma.com |
International Media and Investor Relations Consilium
Strategic Communications Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson Tel.: +44 (0)20 3709 5700
InnatePharma@consilium-comms.com |
ATCG
Press (France) Marie Puvieux Mob: +33 (0)6 10 54 36 72
presse@atcg-partners.com |
|
[*] Third World Congress of Cutaneous
Lymphomas
[*] American Society of Hematology
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/807935fc-5390-4a18-b09d-3ee0f4c8d063
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