Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”), today announced that a
planned futility interim analysis of the INTERLINK-1 Phase 3 study
sponsored by AstraZeneca (LSE/STO/Nasdaq: AZN) did not meet a
pre-defined threshold for efficacy. Based on this result and the
recommendation of an Independent Data Monitoring Committee,
AstraZeneca has informed Innate that the study will be
discontinued. There were no new safety findings. AstraZeneca plan
to share the data in due course.
The INTERLINK-1 study, sponsored by AstraZeneca, evaluated
monalizumab in combination with cetuximab vs. cetuximab in patients
with recurrent or metastatic squamous cell carcinoma of the head
and neck (R/M SCCHN) who have been previously treated with
platinum-based chemotherapy and PD-(L)1 inhibitors.
“The INTERLINK-1 Phase 3 study was intended to further evaluate
a novel immunotherapy regimen following the promising signals
observed in a non-randomized Phase 1b/2 study of head and neck
cancer. While we are disappointed with the outcome of this study,
the findings are certain to advance our understanding of the role
of immunotherapy in this setting,” said Mondher Mahjoubi, Chief
Executive Officer of Innate Pharma. “We remain confident in the
development program for monalizumab in lung cancer, where
encouraging data has been previously reported from the randomized,
Phase 2 COAST and Neo-COAST studies. Our focus for monalizumab
remains on the Phase 3 PACIFIC-9 study in the unresectable Stage
III non-small cell lung cancer setting, as well as the Phase 2
NeoCOAST-2 study in the neoadjuvant early-stage lung cancer
setting.”
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: “We are disappointed by this outcome and
what it means for patients. We would like to thank the patients,
investigators and healthcare professionals who dedicated their time
and expertise to this trial, which has advanced our understanding
of metastatic head and neck cancer. We continue to explore the
impact of monalizumab in patients with non-small cell lung cancer
across different trials, including the Phase 3 PACIFIC-9
trial.”
Monalizumab, Innate’s lead partnered asset, is a potentially
first-in-class immune checkpoint inhibitor targeting NKG2A
receptors expressed on tumor infiltrating cytotoxic CD8+ T cells
and NK cells. It is being studied in a Phase 3 clinical study
sponsored by AstraZeneca, PACIFIC-9, evaluating durvalumab (PD-L1)
in combination with monalizumab or AstraZeneca’s oleclumab
(anti-CD73) in patients with unresectable, Stage III non-small cell
lung cancer (NSCLC) who have not progressed following definitive
platinum-based concurrent chemoradiation therapy.
About INTERLINK-1:
INTERLINK-1 was a global, multi-center, randomized, double-blind
Phase 3 study of monalizumab and cetuximab vs. placebo and
cetuximab designed to enroll approximately 600 patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck (R/M SCCHN) who have been previously treated with
platinum-based chemotherapy and PD-(L)1 inhibitors
(“IO-pretreated”).
The primary endpoint was overall survival (OS) in HPV-unrelated
participants, with secondary endpoints including OS in all
randomized participants, progression-free survival (PFS), overall
response rate, duration of response, safety and quality of life.
Additional details on the INTERLINK-1 clinical study can be found
here.
About monalizumab:
Monalizumab is a potentially first-in-class immune checkpoint
inhibitor targeting NKG2A receptors expressed on tumor infiltrating
cytotoxic CD8+ T cells and NK cells.
NKG2A is an inhibitory checkpoint receptor for HLA-E. By
expressing HLA-E, cancer cells can protect themselves from killing
by NKG2A+ immune cells. HLA-E is frequently overexpressed in the
cancer cells of many solid tumors and hematological malignancies.
Monalizumab may reestablish a broad anti-tumor response mediated by
NK and T cells, and may enhance the cytotoxic potential of other
therapeutic antibodies.
The ongoing development for monalizumab is focused on
investigating monalizumab in various combination strategies in
different malignancies, including, in early lung cancer, the Phase
3 PACIFIC-9 study in adults with locally advanced (Stage III),
unresectable NSCLC, who have not progressed following
platinum-based concurrent chemoradiotherapy, and the Phase 2
NeoCOAST-2 study in the neoadjuvant early-stage setting of
NSCLC.
About the Innate-AstraZeneca monalizumab agreement:
In October 2018, AstraZeneca obtained full oncology rights to
monalizumab by exercising its option under the co-development and
commercialization agreement initiated in 2015.
The financial terms of the agreement include potential cash
payments up to $1.275 billion to Innate Pharma. Including the $50
million payment triggered by dosing the first patient in the Phase
3 PACIFIC-9 clinical study, Innate Pharma has received $450 million
to date.
For any commercialized oncology indication, AstraZeneca will
book all sales revenue and will pay Innate low double-digit to
mid-teen percentage royalties on net sales worldwide except in
Europe where Innate Pharma will receive 50% share of the profits
and losses in the territory. Innate co-fund 30% of the costs of the
Phase 3 development program of monalizumab with a pre-agreed
limitation of Innate’s financial commitment.
About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage oncology-focused
biotech company dedicated to improving treatment and clinical
outcomes for patients through therapeutic antibodies that harness
the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies includes several
potentially first-in-class clinical and preclinical candidates in
cancers with high unmet medical need.
Innate is a pioneer in the understanding of Natural Killer cell
biology and has expanded its expertise in the tumor
microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
Headquartered in Marseille, France with a US office in
Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq
in the US.
Learn more about Innate Pharma at www.innate-pharma.com
Information about Innate Pharma shares:
ISIN code
FR0010331421
Ticker code
Euronext: IPH Nasdaq: IPHA
LEI
9695002Y8420ZB8HJE29
Disclaimer on forward-looking information and risk
factors:
This press release contains certain forward-looking statements,
including those within the meaning of the Private Securities
Litigation Reform Act of 1995. The use of certain words, including
“believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify 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. These
risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including
related to safety, progression of and results from its ongoing and
planned clinical trials and preclinical studies, review and
approvals by regulatory authorities of its product candidates, the
Company’s commercialization efforts, the Company’s continued
ability to raise capital to fund its development and the overall
impact of the COVID-19 outbreak on the global healthcare system as
well as the Company’s business, financial condition and results of
operations. For an additional 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 Universal
Registration Document filed with the French Financial Markets
Authority (“AMF”), which is available on the AMF website
http://www.amf-france.org or on Innate Pharma’s website, and public
filings and reports filed with the U.S. Securities and Exchange
Commission (“SEC”), including the Company’s Annual Report on Form
20-F for the year ended December 31, 2021, and subsequent filings
and reports filed with the AMF or SEC, or otherwise made public, by
the Company.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220731005041/en/
Investors and Media
Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90
32 88 Henry.wheeler@innate-pharma.fr
ATCG Press Marie Puvieux (France) Tel.: +33 981 87 46 72
innate-pharma@atcg-partners.com
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