INNATE PHARMA (EPA:IPH) Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announces that the results of the Phase I trial of IPH2101 in AML were published in BLOOD

Transparency directive : regulatory news

18/10/2012 07:15

PRESS RELEASE

RESULTS OF IPH2101 PHASE I TRIAL IN AML PUBLISHED IN BLOOD

*   23 patients, median age 71, in first complete remission, received
    escalating doses of IPH2101

*   Conclusions support the rationale behind the recently announced
    multicentre, double- blind, Phase II trial of anti-KIR mAb vs placebo to
    be initiated in this patient population

Marseilles, France, October 18, 2012
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH), the
innate immunity company developing first-in-class drugs for cancer and
inflammatory diseases, today announces that the results of the Phase I trial
of IPH2101 (hybridoma anti-KIR antibody) in elderly patients with Acute
Myeloid Leukemia in first complete remission were published online in the
journal Blood.

The Phase I trial evaluated the safety, tolerability and pharmacological
profile of IPH2101 in elderly AML patients in complete remission after
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) and a single dose administration. The objective was to determine a
safe and pharmacologically active dose. Twenty three patients were enrolled in
this study. Good tolerance was observed at all tested doses of IPH2101, adverse
events were mild and transient. The maximum tolerated dose was not reached.

A clear relationship between dose, blood concentration and receptor occupancy
was observed, in accordance with preclinical models and with low inter-patient
variability.

Neither hematologic toxicity nor significant changes in numbers and
distribution of lymphocyte subsets, NK cell receptor expression, or in vitro
cytotoxicity were seen. At the highest dose levels, transient increase in
TNF-alfa and MIP-1beta serum concentrations and NK cell CD69 expression were
observed.

Median progression free survival (PFS), relapse free survival (RFS) and overall
survival (OS) were respectively: 7.7 months (95% CI: 1.8 to 9.5), 10.8 months
(95% CI: 8.8 to 14.4) and 12.7 months (95% CI: 10.9 to 24.2). The 6 patients
treated at dose levels 1 and 3 mg/kg showed a significantly improved OS
compared
to the 16 patients of the previous dose levels (<0.3 mg/kg): 29.7 months
compared to 11.8 months (log rank p= 0.034) and trends towards improved PFS
and RFS (not significant) were also observed.

Dr. Norbert Vey, MD (Institut Paoli Calmettes, Marseille), lead investigator
of the Phase I trial in  AML,  said:  "With  this  trial,  we  have  shown
that full  KIR  occupancy  is  reached  and maintained for time periods (day to
several weeks) that depend on the dose and without reaching the maximum
tolerated dose. Results from the study support continuing investigation of
anti-KIR mAbs in AML".

Marcel Rozencweig, Chief Medical Officer of Innate Pharma, said: "These data
reinforce the rationale for the development of the anti-KIR antibody approach
in Acute Myeloid Leukemia patients. As recently announced, Innate Pharma is
initiating a randomized, placebo-controlled Phase II trial with IPH2102 in
elderly patients with AML in first complete remission, a situation where there
are very few therapeutic options".

The full results are available on-line and will be published soon in a paper
issue of Blood*. Jerome Tiollier, Chief Development Officer of Innate Pharma,
will be discussing the results at the upcoming European Antibody Congress on
November 28 in Geneva, Switzerland in the context of mAb development targeting
immunity checkpoints.

About IPH2102/BMS-986015 and IPH2101:

IPH2102 and IPH2101 are fully human monoclonal antibodies blocking interaction
between Killer-cell immunoglobulin-like receptors (KIR) on Natural Killer (NK)
cells with their ligands. By blocking these receptors, they facilitate
activation of NK cells, and, potentially, destruction of tumor cells by the
latter. IPH2101 is produced in hybridoma cell lines, whereas IPH2102 is
produced in CHO, a cell line more suited for industrialization. IPH2102 is the
candidate to be developed further. A randomized, double-blind, placebo-
controlled Phase II trial has recently been initiated with IPH2102 in AML
elderly patient in a maintenance setting.

IPH2102/BMS-986015 is licensed to Bristol-Myers Squibb Company (NYSE:BMY).
As part of the agreement between Innate Pharma and Bristol-Myers Squibb,
Bristol-Myers Squibb holds exclusive worldwide rights to develop, manufacture
and commercialize IPH2102/BMS-986015 and related compounds blocking KIR
receptors such as IPH2101, for all indications. Under the agreement, Innate
Pharma will complete the development of IPH2102 through Phase II in AML, as
part of the global development plan of Bristol-Myers Squibb for IPH2102.

* A phase I trial of the anti-inhibitory KIR monoclonal antibody IPH2101 for
acute myeloid leukemia (AML) in complete remission, Vey et al., Blood First
Edition Paper, prepublished online 21 September 2012,
DOI10.1182/blood-2012-06-437558

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. Its innovative approach has been validated by licence agreements with
two major pharmaceutical companies, Novo Nordisk A/S and Bristol-Myers Squibb.

Incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006, Innate
Pharma is based in Marseilles, France, and had 81 employees as at
June 30, 2012.

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                                      ATCG Press
Laure-Hélène Mercier                               Marielle Bricman
Director, Investor Relations
Phone: +33 (0)4 30 30 30 87                        Mob.: +33 (0)6 26 94 18 53
investors@innate-pharma.com                        mb@atcg-partners.com

121018 AML Phase I publication in Blood

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INNATE PHARMA (EPA:IPH) Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announces that the results of the Phase I trial of IPH2101 in AML were published in BLOOD

Transparency directive : regulatory news

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