- Preliminary data from the dose-escalation part of an ongoing
Phase I trial in elderly and heavily pretreated patients including
a majority of patients with Sezary syndrome;
- IPH4102 shows good safety profile;
- Encouraging signs of clinical activity, with complete
responses seen in skin and blood.
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 -
IPH), today announces encouraging preliminary safety and clinical
activity results from the dose-escalation part of the Phase I study
testing IPH4102 in patients with relapsed/refractory cutaneous
T-cell lymphomas ("CTCL"), an orphan disease. IPH4102 is Innate
Pharma's wholly-owned, first-in-class anti-KIR3DL2 humanized
therapeutic antibody, designed to trigger immune cell-mediated
killing of CTCL cancer cells.
These data are presented in a poster at the
Third World Congress of Cutaneous Lymphomas (October 26-28, 2016,
New-York, USA) and will be discussed by the Principal Investigator,
Professor Martine Bagot, Head of the Department of Dermatology at
Saint-Louis Hospital (Paris) in the Scientific Session "Endpoints
& Clinical Trials" on October 28, 2016, 1:30 - 2:45 p.m.
EST.
The Phase I study is currently ongoing. Data are
reported for the first seven dose levels (0.0001 to 1.5 mg/kg,
16 patients) of the dose-escalation part. In this population,
IPH4102 was well-tolerated with no dose-limiting toxicity reported.
The majority of adverse events is typical for CTCL or reflects low
grade infusion-related reactions. As of September 10, 2016, the
best global response rate was 38% across all dosage levels.
Complete responses appeared with increasing doses and/or duration
of exposure in skin and blood (respectively 2 and 3, seen in 4
patients)[1]. All responses are ongoing at the time of the
analysis, which occurred after a median duration of treatment of
126+ days (range of 41+ to 298+).
Three additional dose levels (3, 6 and 10 mg/kg)
remain to be evaluated and the dose escalation part of the trial is
now expected to be completed by Q2 2017 (previously expected at the
end of 2017).
"These preliminary results are very encouraging
and fully support the continuation of the development of the
antibody candidate. By targeting KIR3DL2 on CTCL cells and
triggering their killing by immune effector cells, IPH4102 has the
potential to deliver a new treatment option for patients in high
medical need at advanced stages of the disease," said
Pierre Dodion, Chief Medical Officer of Innate Pharma. "The
development of IPH4102 benefits from long lasting collaborations
with Saint Louis Hospital in Paris and reference centers, such as
Stanford (US). Together we look forward to the complete safety data
of the dose-escalation part of the trial and commencing cohort
expansion of this new drug candidate, which is wholly-owned by
Innate Pharma."
Martine Bagot, Principal Investigator and
Head of the Dermatology Department at the Saint-Louis Hospital,
Paris, added: "This study offers preliminary safety and
efficacy results that are promising for IPH4102, in patients with
CTCL subtypes that historically have been shown to be particularly
difficult to treat. We are delighted with the progress that has
been made with this candidate through translational research and an
exceptional academic-industrial partnership."
The study started enrolling patients in November
2015. So far, 16 patients with KIR3DL2-positive CTCL have been
enrolled in seven dose-cohorts, including 13 patients with Sézary
syndrome, 2 patients with mycosis fungoides and 1 patient with CD4+
CTCL. Median age was 71 years and patients had received 2 to 8
lines of prior systemic therapy for their disease.
All of the 16 patients treated with IPH4102 were
evaluable for safety and clinical activity assessments.
As of September 10, 2016, patients had received
up to 18 administrations of IPH4102. Treatment is ongoing in 12
patients. Preliminary results of exploratory endpoints such as
pharmacodynamics in skin and blood are in line with clinical
activity results (see poster #O-11), and show depletion of
KIR3DL2-expressing tumor cells in skin and blood of patients after
IPH4102 administrations.
Presentation/ Poster Details
The oral presentation, entitled "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" will take place
on October 28, 2016, 1:30 - 2:45 p.m. EST. It will be available on
the Company's website, in the Product Pipeline - IPH4102 section
following the session. The associated poster is displayed during
the entire congress and is available on Innate Pharma's
website.
Simultaneously, poster #O-11 entitled
"First-in-Human, open label, multicenter phase I study of IPH4102,
first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory
CTCL: preliminary results of exploratory biomarkers" has been
presented by Hélène Sicard, Anne Marie-Cardine and Maxime
Battistella and is available on Innate Pharma's website under
Product Pipeline - IPH4102.
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 (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). 45 to 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 25 to 40 CTCL patients in
10 dose levels. The 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. The cohort design
(CTCL subtype, number of patients) could 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 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 95% of certain aggressive CTCL
subtypes, in particular, Sézary Syndrome and transformed mycosis
fungoides. It 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, the
leukemic form of CTCL, which 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 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 CTCL patients in Europe and the United
States.
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.
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] In CTCL, global clinical response assessment
is a composite of response evaluation in all organs involved with
tumor cells, such as skin, blood, lymph nodes and viscera (E. Olsen
et al, JCO 2011)
PR in English http://hugin.info/155662/R/2051673/767668.pdf
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