INNATE PHARMA (EPA:IPH) Innate Pharma (Euronext Paris: FR0010331421 – IPH) announces that the US National Cancer Institute starts a Phase II clinical trial with Innate Pharma's IPH 2101

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12/01/2011 17:47

Press release

THE US NATIONAL CANCER INSTITUTE STARTS A PHASE II CLINICAL TRIAL WITH INNATE
                                  PHARMA'S IPH 2101

  IPH 2101 anti-KIR monoclonal antibody is tested in patients with smoldering
                                       myeloma

Marseilles, France, January 12, 2011

Innate Pharma (the "Company" - Euronext Paris: FR0010331421 - IPH) announces
that the National Cancer Institute ("NCI", National Institutes of Health, "NIH",
Bethesda, Maryland, USA) has enrolled a first patient in a new Phase II clinical
trial testing Innate Pharma's antiKIR monoclonal antibody IPH 2101, in patients
with smoldering myeloma, an early stage of the blood malignancy multiple
myeloma.

This trial is developed, sponsored and funded by the NCI and performed in the
United States under a clinical trial agreement with Innate Pharma. Innate Pharma
will provide drug supply and has collaborated to the protocol design. The
principal investigator of this trial is Ola Landgren, MD, PhD (Head, Multiple
Myeloma Section, Center of Cancer Research, NCI, NIH, Bethesda, Maryland, USA).

"The launch of this novel clinical trial for patients with myeloma precursor
disease at the NCI is an additional validation of the interest of the KIR
blockade as a potential therapeutic approach", said Marcel Rozencweig, MD, EVP,
Chief Medical Officer. He added: "Dr. Landgren is an international expert of
multiple myeloma and its precursor conditions. His work will complement our own
study and help us understand the role of activated NK cells in preventing and
delaying transformation from smoldering myeloma into full-blown multiple
myeloma".

About the NCI-sponsored Phase II trial testing IPH 2101:
This study is a single-center, open label Phase II clinical trial designed to
evaluate IPH 2101 as a single agent in patients with previously untreated
smoldering myeloma.

The rationale of this trial is based on the capacity of activated NK cells to
directly kill tumor cells and trigger a broad immune activation. This rationale
is further strengthened by clinical studies showing that activated NK cells can
very significantly lower the recurrence of various hematological malignancies,
including multiple myeloma, following bone marrow transplantation*.

The primary efficacy endpoint is the response rate, based mainly on the decrease
in M protein blood and urine levels, a surrogate marker of the disease. Other
endpoints include safety and pharmacodynamics. NIH's research laboratories will
also conduct extensive correlative studies to define molecular underpinnings of
clinical responses.

The protocol calls for inclusion of 19 patients in a two-stage design and will
test a new administration regimen of IPH 2101.

Innate Pharma sponsors another Phase II trial testing IPH 2101 in smoldering
myeloma patients (KIRMONO trial, see the Product section on the Company's
website www.innatepharma.com).

* See the "About IPH 2101" section

About smoldering myeloma:
Multiple myeloma ("MM") is the second most common hematological malignancy, with
over 20,000 new cases diagnosed every year in the United States and a similar
incidence in Europe (Jemal et al., 2009). It is characterized by a malignant
proliferation of abnormal plasma cells which populate the marrow-containing
bones of the body. This translates into the overproduction of a monoclonal
immunoglobulin (known as M-protein) which can be detected in the blood and used
as a marker for the diagnosis and the follow-up of the disease.

Smoldering myeloma is an asymptomatic precursor state of MM. On average,
patients with smoldering myeloma have an annual 10% risk of progressing to MM
(Waxman AJ et al. Clin Lymphoma Myeloma Leuk. 2010;10(4):248-57). At present, it
has been estimated that smoldering myeloma accounts for approximately 15% of all
newly diagnosed MM patients (Dimopoulos MA et al Blood 2000; 96:2037-44).
Because it is asymptomatic and not treated today, smoldering myeloma is likely
to be significantly under-diagnosed. It is reasonable to conjecture that the
actual incidence for smoldering myeloma should be equal to or greater than the
one of MM, as nearly all MM appear to derive from asymptomatic plasma cell
proliferation (Landgren O. et al Blood 2009; 113: 5412-7 and Weiss BM et al
Blood 2009; 113: 5418-22).

About IPH 2101:
IPH 2101 is a fully human anti-KIR monoclonal antibody which potentiates NK
cells' anti-cancer activity by blocking inhibitory NK cell receptors.

This therapeutic approach to cancer has been indirectly validated by the work of
Professor Andrea Velardi's research group at the University of Perugia in Italy
(first published in 2002 and regularly updated since then). The work shows that
following bone marrow transplantation from healthy donors in patients suffering
from myeloid leukemia, grafted NK cells lacking functional KIR (inhibitory)
receptors demonstrate high anti-tumoral activity - resulting in significantly
higher patient survival rates. Another group published in 2005 similar results
in patients transplanted with healthy donor hematopoietic cells for treatment of
multiple myeloma. By blocking KIR receptors on NK cells, IPH 2101 aims at
mimicking this situation (for more details, see the "IPH 2101" section at
www.innate-pharma.com).

IPH 2101 has been tested in more than 50 patients so far. In these patient
populations, IPH 2101 has been very well tolerated and met the pharmacodynamic
objective of receptor saturation.

About natural killer (NK) cells:
Natural killer (NK) cells are a type of white blood cell from the lymphocyte
family, which also includes T cells and B cells.

These NK cells are present in large numbers in the bloodstream (accounting for
up to 10% of circulating lymphocytes) and form part of the so-called innate
immune system - the body's first line of defense against pathogens.

Natural killer cells are controlled by stimulatory and inhibitory signals
received by surface receptors and can kill both malignant and virally-infected
cells. They also play a key role in the control of inflammatory reactions and in
the triggering and regulation of long-term adaptive immune responses.

About the NIH and the NCI:
The NIH, a part of the U.S. Department of Health and Human Services, is the
primary Federal agency for conducting and supporting medical research. Helping
to lead the way toward important medical discoveries that improve people's
health and save lives, composed of 27 Institutes and Centers, the NIH provides
leadership and financial support to researchers in every state and throughout
the world.

With the headquarters in Bethesda, Maryland, the NIH has more than 18,000
employees on the main campus and at satellite sites across the U.S. With the
support of the American people, the NIH annually invests over $28 billion in
medical research. More than 83% of the NIH's funding is awarded through almost
50,000 competitive grants to more than 325,000 researchers at over 3,000
universities, medical schools, and other research institutions in every state
and around the world. About 10% of the NIH's budget supports projects conducted
by nearly 6,000 scientists in its own laboratories, most of which are on the NIH
campus in Bethesda, Maryland.

The NCI coordinates the National Cancer Program, which conducts and supports
research, training, health information dissemination, and other programs with
respect to the cause, diagnosis, prevention, and treatment of cancer,
rehabilitation from cancer, and the continuing care of cancer patients and the
families of cancer patients.

The Center for Cancer Research (CCR) is home to more than 250 scientists and
clinicians working in intramural research at NCI. CCR is part of the Clinical
Center at the NIH in Bethesda, Maryland, the largest hospital devoted entirely
to clinical research in the U.S. The Clinical Center is a national resource that
makes it possible to rapidly translate scientific observations and laboratory
discoveries into new approaches for diagnosing, treating, and preventing
disease. CCR's investigators are basic, clinical, and translational scientists
who work together to advance scientific knowledge and to develop new
therapies.

About Innate Pharma:

Innate Pharma S.A. is a biopharmaceutical company developing first-in-class
immunotherapy drugs for cancer and inflammatory diseases.

The Company specializes in the development of new monoclonal antibodies
targeting receptors and pathways controlling the activation of innate immunity
cells. It has two proprietary clinical-stage drug candidates: IPH 1101, a small
molecule agonist of gamma delta T cells, has achieved proof-of-concept in two
Phase IIa trials, in type C viral hepatitis and follicular lymphoma. IPH 2101,
an anti-KIR monoclonal antibody potentiating NK cells activation, is currently
in Phase II clinical trials in hematologic cancers. Innate Pharma is also
developing a preclinical portfolio of immunomodulatory or cytotoxic monoclonal
antibodies. Two of its preclinical programs in chronic inflammation have been
out-licensed to Novo Nordisk A/S.

Innate Pharma's key expertise is in immunopharmacology and antibody technology.
The Company has implemented in-house a large panel of molecular and cellular
assays and in vivo models for assessing the pharmacodynamics and
pharmacotoxicology of drug candidates. In addition, Innate Pharma has access to
a very large set of unique research tools in cellular immunology through its
worldwide network of scientific collaborations.

Incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006, Innate Pharma
is based in Marseilles, France, and had 84 employees as at September 30, 2010.

Learn more about Innate Pharma at www.innate-pharma.com.

Practical Information about Innate Pharma shares:

ISIN code                  FR0010331421
Ticker code                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                                     Alize Public Relations
Laure-Hélène Mercier                              Caroline Carmagnol
Director, Investor Relations                      Phone: +33 (0)1 41 22 07 31
Phone: +33 (0)4 30 30 30 87                       Mobile: +33 (0)6 64 18 99 59
investors@innate-pharma.com                       caroline@alizerp.com

110112 IPH 2101 NCI sponsored trial

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INNATE PHARMA (EPA:IPH) Innate Pharma (Euronext Paris: FR0010331421 – IPH) announces that the US National Cancer Institute starts a Phase II clinical trial with Innate Pharma's IPH 2101

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