-
Oral
presentation on data with longer follow-up of dose escalation
patients and new data from cohort expansion in the Phase I study at
the EORTC CLTF 2018 Meeting
-
IPH4102 showed
encouraging clinical activity, demonstrated by high response rate
and long progression-free survival (PFS)
-
Sézary
syndrome (SS) subset patients treated in the dose-escalation part
(n=20) now show median PFS of close to 1 year
Marseille, France, September 29, 2018, 8:30 AM
CEST
Innate Pharma SA (the "Company" -
Euronext Paris: FR0010331421 - IPH), today announced new data from
the Phase I clinical trial of IPH4102 in patients with
relapsed/refractory cutaneous T-cell lymphomas (CTCL). The data,
including longer follow up for patients treated in the
dose-escalation and observations from an additional patient cohort,
will be presented today at the EORTC Cutaneous Lymphoma Group
meeting in St. Gallen, Switzerland, by Pr Martine Bagot,
Principal Investigator and Head of the Dermatology Department at
the Saint-Louis Hospital, Paris. IPH4102 is Innate Pharma's
wholly-owned first-in-class anti-KIR3DL2 antibody, designed for
treatment of T-cell lymphoma.
"These data
support the positive trends observed in the dose-escalation part of
the trial and demonstrated a high response rate and long
progression-free survival for these heavily pretreated CTCL
patients, a majority being Sézary syndrome," commented Pierre Dodion, Chief Medical
Officer of Innate Pharma. "Additionally,
these data will serve as a basis for the
initiation of a broader Phase II clinical program in Sézary
syndrome and other subtypes of T-cell lymphomas. We look forward to
providing more insight into the data and subsequent clinical
development plans in the near future."
As of June 28, 2018, a total of 44
patients with relapsed/refractory CTCL were evaluable for safety
and clinical activity. The study consisted of two parts: a
dose-escalation (n=25) and a cohort expansion (n=19). Patients
received a median of 3 prior systemic therapies. IPH4102
demonstrated a favorable safety profile and was well-tolerated. The
study showed clinical activity that was demonstrated by a high
response rate and long progression free survival.
In the total study population, the
objective response rate (ORR) was 36% and median duration of
response (DOR) and progression free survival (PFS) were 13.8 and
8.2 months, respectively. Sézary syndrome (SS) subset patients
treated in the dose-escalation part (n=20) now show median PFS of
close to 1 year. At the cut-off date of June 28, 2018, median
follow-up was 12.7 months and nine patients were still ongoing
treatment.
Better outcomes were observed in
patients without evidence of histologic large cell transformation
(LCT) (n=29); these patients achieved an ORR of 51.7% and PFS of
12.8 months. LCT is present in approximatively 10% of all
Mycosis fungoides/Sézary syndrome patients[1] and is
associated with poorer prognosis and shorter survival using
currently available therapies.
"This patient
population remains a high unmet medical need as they continue to
progress through several lines of treatments," commented Pr Martine Bagot, Principal
Investigator. "The patients with complete
response, partial response and even those with stable disease
showed an improvement in quality of life parameters overtime
including pruritus. IPH4102's encouraging clinical activity
provides substantial support to explore its potential therapeutic
benefits not only in SS patients but also in other T cell lymphoma
patient populations. Together with a favorable safety profile,
IPH4102 could emerge as a key therapeutic option in aggressive
T-cell lymphomas."
The presentation is available in
the IPH4102 section on Innate Pharma's website.
About the 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). Up
to 55 patients with advanced CTCL having received at least two
prior lines of systemic therapy were to 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. Safety data of
all dose levels were presented at the ICML meeting on June 14,
2017. Final results of the dose-escalation part were presented at
the EORTC CLTF Meeting on October 15, 2017.
-
The cohort expansion enrolled 15 patients with Sézary Syndrome and
4 tMF receiving IPH4102 at the RP2D until progression.
The primary objective of this
trial was to evaluate the safety and tolerability of repeated
administrations of single agent IPH4102 in this patient population.
The secondary objectives included assessment of the drug's
antitumor activity. Clinical endpoints included global objective
response rate, response duration and progression-free survival.
Exploratory analyses are 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 and in the United States 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 lymphomas
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 190 employees and is listed on Euronext
Paris.
Learn more about Innate Pharma at
www.innate-pharma.com.
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:
Investors
Innate Pharma
Dr. Markus Metzger/ Danielle Spangler
Jérôme Marino
Tel.: +33 (0)4 30 30 30 30
investors@innate-pharma.com |
International Media and Investor
Relations
Consilium Strategic Communications
Mary-Jane Elliott / 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 |
Innate Pharma reports IPH4102
results in advanced CTCL
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: INNATE PHARMA via Globenewswire
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