INNATE PHARMA (EPA:IPH) Innate Pharma (the “Company” - Euronext Paris: FR0010331421 – IPH) announces today that it has started patient inclusion in a new multicenter Phase II clinical trial with anti-KIR monoclonal antibody IPH 2101 in smoldering myeloma patients

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23/11/2010 17:45

Press release

INITIATION OF A PHASE II CLINICAL TRIAL WITH ANTI-KIR MONOCLONAL ANTIBODY IPH
2101 IN SMOLDERING MYELOMA PATIENTS

Marseilles, France, November 23, 2010

Innate Pharma (the "Company" - Euronext Paris: FR0010331421 - IPH) announces
today that it has started patient inclusion in a new multicenter Phase II
clinical trial with IPH 2101, an antiKIR monoclonal antibody potentiating the
anti-tumor activity of NK cells. In this trial, IPH 2101 is tested as a single
agent in patients with smoldering myeloma, an early state of the blood
malignancy multiple myeloma. The trial is conducted in the United States at
multiple major hospitals (IPH2101-203 or "KIRMONO" trial).

"This is an important study for IPH 2101 as it will test the drug candidate in
patients with early disease and a limited tumor burden - a favorable setting
for immunotherapy. Furthermore, this is the first trial to be initiated and
sponsored by Innate Pharma in the USA. We are delighted to have the support of
leading clinical groups such as the Dana Farber Cancer Institute ("DFCI") in
Boston", said Marcel Rozencweig, MD, Innate Pharma's Executive Vice President
and Chief Medical Officer.

Nikhil C. Munshi, MD, a DFCI investigator and Associate Professor of Medicine
at Harvard Medical School, added: "We are very interested in testing IPH 2101
in this patient population: the anti-tumor effect of NK cells seems to play an
important role in the control of plasma cell proliferation and might be easily
enhanced by IPH 2101. Furthermore, IPH 2101 has been very well tolerated so
far. This is a key feature for patients with asymptomatic disease for whom
there is no established standard of care".

About the Phase II trial testing IPH 2101 in Smoldering Myeloma (IPH 2101-203
or "KIRMONO"):

IPH 2101-203 is a multicenter, 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 trial's primary efficacy endpoint is the response rate, based mainly on
the decrease in blood and urine levels of M-protein, a surrogate marker of the
disease. Other endpoints include safety and pharmacodynamics.

The protocol calls for inclusion of 30 patients, divided into 2 groups
receiving IPH 2101 for 6 cycles. Responding patients will receive 6 additional
cycles.

* 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 antibody (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 or
higher 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 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

101123 IPH 2101 KIRMONO

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05/04/2024 09:34

INNATE PHARMA (EPA:IPH) Innate Pharma (the “Company” - Euronext Paris: FR0010331421 – IPH) announces today that it has started patient inclusion in a new multicenter Phase II clinical trial with anti-KIR monoclonal antibody IPH 2101 in smoldering myeloma patients

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