INNATE PHARMA (EPA:IPH) Innate Pharma (Euronext Paris: FR0010331421 – IPH) announces that it has received approval from AFSSaPS to start an extension of the Phase I clinical trial with its monoclonal antibody IPH 2101 in patients with acute myeloid leukemia

Transparency directive : regulatory news

02/11/2009 18:59

PRESS RELEASE

INNATE PHARMA MOVES FORWARD ANTI-KIR MONOCLONAL ANTIBODY IPH 2101 DEVELOPMENT
WITH STUDY EXTENSION IN ACUTE MYELOID LEUKEMIA

* Other Phase I/II or IIa trials are planned with this drug candidate

* In the context of the French new "anti-cancer plan" announcement, IPH 2101
  was presented to government officials

Marseilles, France, November 2, 2009

Innate Pharma (the "Company" - Euronext Paris: FR0010331421 - IPH) announces
today that it has received approval from AFSSaPS (the French regulatory
authorities) to start an extension of the Phase I clinical trial with IPH 2101,
a monoclonal antibody potentiating NK cells antitumoral activity, in patients
with acute myeloid leukemia ("AML").

This trial extension calls for the enrolment of an additional cohort of twelve
patients in complete remission after their first-line treatment for AML. The
Phase I study has shown very good results in terms of safety and
pharmacodynamic activity with repeated administration of IPH 2101. Based on
these encouraging results, the objective of the trial extension is to confirm
these data in a larger cohort of patients, as well as to document disease-free
survival ("DFS") in this population and is part of Innate Pharma's plan to
obtain early efficacy results for IPH 2101 in AML.

The Phase II program in multiple myeloma ("MMy") with this agent has recently
started with the previously announced Phase IIa trial evaluating IPH 2101 as a
single agent in maintenance of response for MMy patients. The Company intends
to initiate additional Phase I/II or IIa trials with IPH 2101, including one in
patients with relapsed myeloma, in combination with the standard of care, and
one in smoldering myeloma, the early stage of the multiple myeloma disease
("pre-myeloma").

"We believe that IPH 2101 could extend the duration of remission without
increasing the toxicity in AML patients" said Hervé Brailly, CEO of
Innate Pharma. He added: "IPH 2101 program should generate data by 2011-2013,
potentially leading Innate Pharma to start registration trials in 2013."

"Acute myeloid leukemia is a devastating disease, notably for elderly patients,
with a 5-year survival rate of 5%-15%," said Dr. Norbert Vey (Hematology
Department, Paoli Calmettes Institute, Marseille, France), lead investigator of
the trial. He added: "If IPH 2101 shows an improvement of disease-free survival
in the extension trial, it could rapidly be evaluated in a registration
trial".

The French President, Mr. Nicolas Sarkozy, presented today the new French
"cancer plan" and visited the Paoli-Calmettes Institute, one of France leading
anti-cancer centres. During this visit, IPH 2101 was presented by
representatives from Paoli-Calmettes Institute as a case study of a
collaborative work between an anti-cancer centre, academic labs and an industry
player (Innate Pharma), leading to the acceleration of therapeutic innovation
in oncology.

About the Phase I trial in acute myeloid leukemia (IPH 2101-101 and extension
IPH 2101-102):

IPH 2101-101 was a Phase I trial evaluating the safety, tolerability and
pharmacological profile of single dose IPH 2101 in elderly AML patients in
complete remission after first induction and consolidation treatment. The trial
featured a dose-escalation protocol with seven dose levels (from 0.0003 to
3 mg/kg with 3 patients per dose level). The objective was to determine a safe
and pharmacologically active dose.

Twenty-three patients were enrolled in the study. Preliminary data for these
patients revealed good tolerance at all tested doses of IPH 2101, with rare,
transient and moderate adverse events. Drug-related adverse events were mostly
fever, rash and pruritus. The Maximum Tolerated Dose has not been reached.

A clear relationship between dose/ blood concentration/ receptor occupancy was
observed, in accordance with preclinical models and with low inter-patient
variability. The full receptor occupancy objective was met. These results were
presented at the 2009 ASCO meeting (the poster is available on the company's
website - www.innate-pharma.com, in the IPH 2101 / AML section).

Patients from the Phase I trial who have not relapsed at the end of their
treatment cycle can enter an extension study with repeated administrations
(IPH 2101-102).

IPH 2101-102 is now being extended with an additional cohort of 12 patients who
will receive repeated administration of IPH 2101 at a dose of 1mg/kg dose. The
objective of this trial extension is to confirm on a larger AML patient
population the safety and the pharmacodynamic properties of repeated doses of
IPH 2101. The trial could also provide activity data on remission duration.

Safety and pharmacodynamic data from the Phase I trial in AML were reported at
the 2009 ASCO meeting last June. New data from this trial will be reported at
the upcoming American Society of Hematology ("ASH") meeting (New Orleans, USA,
5-8 December 2009), in an oral presentation by Dr. Norbert Vey (Hematology
Department, Paoli Calmettes Institute, Marseille, France), lead investigator
of the trial. Two other scientific presentations (posters) on IPH 2101 will
also be made during this meeting.

About IPH 2101:

IPH 2101 is a fully human anti-KIR monoclonal antibody which potentiates NK
cells' antitumoral activity by blocking their inhibitory receptors.

This cancer therapeutic approach 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
in bone marrow transplantation for patients suffering from myeloid leukemia or
multiple myeloma, grafted NK cells lacking functional KIR (inhibitory)
receptors demonstrate high anti-tumoral activity - resulting in significantly
higher patient survival rates (for more details, see www.innate-pharma.com,
in the IPH 2101 section and in the I2 section of the newsletter to shareholders
n°5 available in the document center of the company website).).

IPH 2101 was listed as one of the 30 most promising cancer investigational
drugs by R&D Directions magazine (2008).

About acute myeloid leukemia ("AML"):

Acute myeloid leukemia is one of the most common types of leukemia in adults in
the United States and Europe. 13,290 new cases of AML were diagnosed in the
United States in 2008, accounting for more than 30% of all leukemias
(source: American Cancer Society). The incidence of AML is low below the age
of 40 but increases progressively with age, from approximately 1 per 100,000
at 40 to more than 15 per 100,000 at 75 and over. Most patients are diagnosed
with AML after the age of 65 (Source: SEER Cancer Statistics Review, 2003).

In elderly patients, the prognosis for AML is very unfavorable, with a 5-year
survival rate of about 5%-15%. Although the complete treatment response rate
is 50 to 60%, most patients relapse rapidly.

At present, the usual induction therapy (aimed at reducing the leukemic cell
burden) is chemotherapy. One of the post-remission therapies is stem cell
transplantation.

Successful treatment is far less frequent in elderly AML patients than in
younger patients. Therefore, there is a need for an efficient drug with a
better safety profile than existing AML treatment regimens - especially for
elderly patients.

About natural killer (NK) cells:
Natural killer 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. ("the company") is a clinical-stage biopharmaceutical
company developing first-in-class immunotherapy drugs for cancer and other
severe diseases. The company was incorporated in 1999 and listed on
NYSE-Euronext in Paris in 2006. It currently has seven proprietary drug
candidates in development (two of which are in Phase II clinical trials) and
two programs out-licensed to Novo Nordisk A/S.

Innate Pharma is based in Marseilles, France, and had 84 employees as at
September 30, 2009.

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.fr        caroline@alizerp.com

091102_IPH 2101_extention AML

INNATE PHARMA's latest news

05/04/2024 09:34

INNATE PHARMA (EPA:IPH) Innate Pharma (Euronext Paris: FR0010331421 – IPH) announces that it has received approval from AFSSaPS to start an extension of the Phase I clinical trial with its monoclonal antibody IPH 2101 in patients with acute myeloid leukemia

Transparency directive : regulatory news

INNATE PHARMA's latest news

Other stories