encouraging
initial results for IPH4102 presented at the Third WORLD Congress
of Cutaneous LYMPhomas
-
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.
Marseille, France,
October 26, 2016
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)
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Source: INNATE PHARMA via Globenewswire
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