INNATE PHARMA TO HOST KEY OPINION LEADER
CALL ON IPH4102 “TELLOMAK” CLINICAL TRIAL DESIGN
AND
RATIONALE
Marseille,
France, June 20, 2019, 07:00 AM CEST
Innate Pharma SA (the “Company” - Euronext
Paris: FR0010331421 – IPH), today announced that it will host a key
opinion leader (KOL) call focused on the topic of IPH4102
“TELLOMAK” clinical trial design and rationale in T-cell lymphoma,
including preclinical data in peripheral T-cell lymphoma (PTCL)
today, Thursday, June 20, at 2pm CEST / 8am ET.
The
call will feature a presentation by Dr. Pierluigi Porcu, MD, key
opinion leader and Principal Investigator of the TELLOMAK study. He
will discuss the cutaneous T-cell lymphoma (CTCL) and PTCL
treatment landscapes and rationale of the TELLOMAK trial design.
Innate's Chief Medical Officer, Pierre Dodion, MD, will also
provide strategic perspectives on IPH4102’s development.
Prof. Pierluigi Porcu is Director of the
Division of Medical Oncology and Hematopoietic Stem Cell
Transplantation at the Jefferson University Hospital in
Philadelphia, PA, USA. Prof. Porcu is a Lymphoma-focused
hematologic oncologist with a long track record of advocacy and
education for patients with cutaneous lymphoma.
To view the presentation and posters presented
at the International Conference on Malignant Lymphoma (“ICML”)
visit:
https://www.innate-pharma.com/en/actus/evenements/icml-2019-lugano-switzerland
KOL webcast and conference call on
Thursday, June 20, at 2pm CEST (8am ET)
The presentation and access to the live webcast
will be available at this link:
https://edge.media-server.com/m6/p/sq5czucf
Participants can also join the conference call
using the following dial-in numbers:
Location
Phone number
France
+33 (0) 176700794
United Kingdom, International
Switzerland
United States
The participation code is: 9493234
An audio replay will be made available a few
hours after the session via Innate Pharma’s website:
https://www.innate-pharma.com/en/actus/evenements/icml-2019-lugano-switzerland
About TELLOMAK:
TELLOMAK is a global, open-label, multi-cohort
Phase II clinical trial conducted in the United States and Europe.
In this trial, IPH4102 is being evaluated alone and in combination
with chemotherapy in patients with advanced TCL. TELLOMAK is
expected to recruit up to 250 patients, with IPH4102 evaluated:
- As a single agent in approximately 60 patients with Sézary
syndrome who have received at least two prior treatments, including
mogamulizumab,
- As a single agent in approximately 90 patients with MF who have
received at least two prior treatments, and
- In combination with standard chemotherapy (gemcitabine and
oxaliplatin) in approximately 100 patients with PTCL who have
received at least one prior treatment.
In patients with MF and PTCL, the study is
designed to evaluate the benefit of IPH4102 according to KIR3DL2
expression. The study will comprise two cohorts for each of the 2
indications, testing IPH4102 in KIR3DL2 expressing and
non-expressing patients. These cohorts will follow a Simon 2-stage
design that will terminate if treatment is considered futile. The
Sézary syndrome arm of the study could enable the registration of
IPH4102 in this indication.
The primary endpoint of the trial is objective
response rate. Key secondary measures include incidence of
treatment emergent adverse events, quality of life, overall
response rate, progression-free survival and overall 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 85% of them with certain
aggressive CTCL subtypes, in particular, Sézary syndrome. 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.
In January 2019, the US Food and Drug Administration (FDA) granted
Innate Pharma Fast Track designation for IPH4102 for the treatment
of adult patients with relapsed or refractory Sézary syndrome who
have received at least two prior systemic therapies.
About Cutaneous T-Cell
Lymphoma:
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.
MF, 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. There are approximately 6,000 new CTCL
cases in Europe and the United States per year.
About Peripheral T-Cell
Lymphoma:
PTCL represents a group of non-Hodgkin lymphomas
of mature T-cell origin with generally aggressive clinical
behavior. The three predominant aggressive PTCL subtypes in the
Western countries are: PTCL not otherwise specified (NOS);
angioimmunoblastic T cell lymphoma (AITL); and anaplastic T cell
lymphoma (ALCL). In the aggregate, PTCL accounts for approximately
10% of all non-Hodgkin’s lymphomas and has a median age at
diagnosis around 65 years.
Multi-agent chemotherapy is the recommended
first line treatment for the majority of patients with PTCL (NCCN
guidelines). Brentuximab vedotin has been approved by the US FDA in
combination with first line chemotherapy for patients with CD30
positive PTCL in November 2019. Stem cell transplantation (SCT) is
a potentially curative option but is rather restricted to a
minority of patients who are young, fit and achieve complete
response to systemic therapy. Hence a high proportion of patients
need second line therapy. Belinostat, pralatrexate and romidepsin
have been approved by the FDA in this setting, but efficacy is
generally limited. None of these treatments have been approved by
the EMA. Brentuximab vedotin is also approved in the 2nd line
setting, but if used in the first line, it may no longer be an
option for 2nd line patients.
About Innate Pharma:
Innate Pharma S.A. is a commercial stage
oncology-focused biotech company dedicated to improving treatment
and clinical outcomes for patients through therapeutic antibodies
that harness the immune system to fight cancer.
Innate Pharma’s commercial-stage product,
Lumoxiti, in-licensed from AstraZeneca, was approved by the FDA in
September 2018. Lumoxiti is a first-in class specialty oncology
product for hairy cell leukemia (HCL). Innate Pharma’s broad
pipeline of antibodies includes several potentially first-in-class
clinical and preclinical candidates in cancers with high unmet
medical need.
Innate has been a pioneer in the understanding
of NK cell biology and has expanded its expertise in the tumor
microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
Based in Marseille, France, Innate Pharma is
listed on Euronext Paris.
Learn more about Innate Pharma at
www.innate-pharma.com
Information about Innate Pharma
shares:
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codeLEI |
FR0010331421IPH9695002Y8420ZB8HJE29 |
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 French Financial Markets
Authority (“AMF”), which is available on the AMF website
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
Consilium Strategic Communications Mary-Jane
Elliott / Jessica Hodgson Tel.: +44 (0)20 3709 5700
InnatePharma@consilium-comms.com |
|
French Media ATCG
Press Marie Puvieux Mob: +33 (0)6 10 54 36
72innate-pharma@atcg-partners.com |
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