INNATE PHARMA : Start of Phase I clinical trial of monalizumab in combination with durvalumab
08 Février 2016 - 7:06AM
- Multicenter, open-label, dose-escalation and cohort-expansion
Phase I study of durvalumab in combination with monalizumab in
patients with solid tumors;
- Trial performed by AstraZeneca/MedImmune in the United States
and in Europe;
- This fifth trial with monalizumab completes the roll-out of the
initial clinical plan, due to start reading out in 2017.
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 -
IPH) today announces the start of a Phase I combination trial of
the two checkpoint inhibitors monalizumab (anti-NKG2A antibody) and
durvalumab (anti-PD-L1 antibody).
This trial is a multicenter, open-label,
dose-escalation and cohort-expansion study to evaluate the safety,
tolerability and antitumor activity of the combination in patients
with selected advanced solid tumors. It will include up to 208
patients, and will be performed in the United States and in
Europe.
Pierre Dodion, Chief Medical Officer of Innate
Pharma, said: "There is a strong rationale for combining immune
checkpoints inhibitors. Combinations with PD-1/PD-L1 inhibitors are
of particular interest given the antitumor activity already
reported for these agents and we are therefore excited to
simultaneously target PD-L1 and NKG2A checkpoints in this trial".
He added: "All the trials of the initial monalizumab development
plan are now open and we expect to see first data in 2017.
Concurrently, we are working on expanding the program to further
explore the potential of monalizumab".
The rationale of the combination of durvalumab
and monalizumab will be presented at a scientific meeting during
2016.
This trial is part of a global co-development
and commercialization agreement with AstraZeneca for monalizumab
signed in April 2015. Five Phase I/II trials are now ongoing,
testing monalizumab in a variety of solid and hematologic tumors,
as a single-agent and in various combinations, exploring the
clinical impact of monalizumab's ability to stimulate direct tumor
killing by cytotoxic NK and T cells, and different mechanisms of
synergy with other immunomodulators, including T cell activators
and ADCC-inducing antibodies.
About study D419NC00001: This trial is a
Phase I, multicenter, open-label, single-arm dose-escalation and
cohort-expansion study of durvalumab in combination with
monalizumab in adult subjects with advanced solid tumor
malignancies. It will include up to 208 patients, and will be
performed in the United States and in Europe.
The rationale for this trial is based on the
potential synergy in blocking several checkpoints expressed on
tumor infiltrating immune cells. Durvalumab is an investigational
anti-PD-L1 monoclonal antibody. By binding to PD-L1, durvalumab
blocks the interaction of PD-L1 with the inhibitory receptors PD-1
and CD80 (B7.1) on the surface of T cells and may re-establish an
anti-tumor response mediated by T cells. The checkpoints targeted
by durvalumab and monalizumab are both upregulated in many cancers,
suggesting they both contribute to tumor immune escape, and that
simultaneous blockade of both inhibitory pathways may be necessary
for fully unleashing effective anti-tumor immune responses. The
primary endpoint of the study is safety, with antitumor efficacy
being a key secondary endpoint. Other secondary endpoints include
response duration, progression free survival, overall survival,
pharmacokinetics, pharmacodynamics, and immunogenicity of
durvalumab and monalizumab given in combination.
About monalizumab (IPH2201):
Monalizumab is a first-in-class immune
checkpoint inhibitor targeting NKG2A receptors expressed on tumor
infiltrating cytotoxic CD8 T lymphocytes and NK cells.
NKG2A is an inhibitory receptor binding HLA-E.
By expressing HLA-E, cancer cells can protect themselves from
killing by NKG2A+ immune cells. HLA-E is frequently up-regulated on
cancer cells of many solid tumors or hematological malignancies.
Monalizumab, a humanized IgG4, blocks the binding of NKG2A to HLA-E
allowing activation of NK and cytotoxic T cell responses. Hence,
monalizumab may re-establish a broad anti-tumor response mediated
by NK and T cells. Monalizumab may also enhance the cytotoxic
potential of other therapeutic antibodies.
Monalizumab is partnered with AstraZeneca and
MedImmune, AstraZeneca's global biologics research and development
arm, through a co-development and commercialization agreement. The
initial development plan includes: a combination trial with
durvalumab (MEDI4736) in solid tumors; multiple Phase II trials
conducted by Innate Pharma to study monalizumab both as monotherapy
and in combination with currently approved treatments across a
range of cancers; and the development of associated biomarkers. As
previously announced, under the terms of this agreement, Innate
Pharma is eligible to cash payments of up to $1.275 billion as well
as double digit royalties on sales. In addition to the initial
payment of $250 million AstraZeneca will pay Innate Pharma a
further $100 million at the decision to go into Phase III
development, as well as additional regulatory and sales-related
milestones of up to $925 million. AstraZeneca will book all sales
and will pay Innate Pharma double-digit royalties on net sales. The
arrangement includes the right for Innate Pharma to co-promote in
Europe for a 50% profit share in the territory.
About Innate Pharma:
Innate Pharma S.A. is a biopharmaceutical
company discovering and developing first-in-class therapeutic
antibodies for the treatment of cancer and inflammatory
diseases.
The Company has three clinical-stage programs,
including two checkpoint inhibitors in immuno-oncology, a new
therapeutic field that is changing cancer treatment by enhancing
the capability of the body's own immune cells to recognize and kill
cancer cells.
Its innovative approach has translated into
alliances with leaders in the biopharmaceutical industry such as
Bristol-Myers Squibb and AstraZeneca, Sanofi and Novo Nordisk
A/S.
Listed on Euronext-Paris, Innate Pharma is based
in Marseille, France, and had 118 employees as at December 31,
2015.
Learn more about Innate Pharma at
www.innate-pharma.com.
Practical Information about Innate Pharma
shares:
ISIN
code Ticker code |
FR0010331421 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 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 Director,
Investor Relations |
Marie
Puvieux (France) Mob: +33 (0)6 10 54 36 72 Jean-Medhi Grangeon
(ROW) |
Tel.: +33 (0)4 30 30 30 87 |
Mob: +33
(0)6 62 22 00 24 |
investors@innate-pharma.com |
presse@atcg-partners.com |
Start of Phase I trial of monalizumab in combination with
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