- First patient dosed in Phase 3 trial, PACIFIC-9, evaluating
durvalumab in combination with monalizumab or oleclumab in patients
with unresectable, Stage III non-small cell lung cancer
- Milestone payment further bolsters Innate’s cash
position
- Second Phase 3 monalizumab trial now initiated by
AstraZeneca
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced that
AstraZeneca (LSE/STO/Nasdaq: AZN) has now dosed the first patient
in its Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab
(PD-L1) in combination with monalizumab (NKG2A) 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 (CRT).
The purpose of the study, which is sponsored by AstraZeneca, is
to determine if the addition of monalizumab or oleclumab to
standard-of-care durvalumab improves outcomes for patients in this
setting.
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.
Dosing of the first patient in this trial has triggered a $50
million milestone payment from AstraZeneca to Innate.
“We are very pleased that our key late-stage asset, monalizumab,
has progressed into a second Phase 3 trial with our partner,
AstraZeneca. The launch of PACIFIC-9 represents an important
financial milestone for Innate, as it triggers a $50 million
milestone payment that reinforces our cash position,” said Mondher
Mahjoubi, Chief Executive Officer of Innate Pharma. “Based on the
recent COAST clinical trial results, we are excited about the
potential of extending the clinical benefit of durvalumab with the
addition of monalizumab in patients with unresectable, Stage III
NSCLC.”
Detailed results from the randomized COAST Phase 2 trial were
published in the Journal of Clinical Oncology on April 22, 2022.
AstraZeneca initially presented the results during the European
Society for Medical Oncology (ESMO) Congress 2021 in September 2021
(see AstraZeneca press release). The results of the interim
analysis showed monalizumab in combination with durvalumab
increased objective response rate (ORR) and prolonged
progression-free survival (PFS) versus durvalumab alone in patients
with unresectable, Stage III NSCLC who had not progressed after
CRT. The Journal of Clinical Oncology publication now includes
exploratory subgroup analysis.
“Durvalumab has transformed the treatment of patients with
unresectable, Stage III NSCLC, and we’re excited by the promise of
extending its benefit through novel combinations with two potential
first-in-class monoclonal antibodies demonstrating strong clinical
activity. Based on the stand-out results from COAST, we are pleased
that the Phase 3 trial is underway, which we hope will bring new
treatment options to patients and further increase the potential
for long-term survival benefit in this setting,” said Susan
Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca.
About PACIFIC-9:
PACIFIC-9 is a Phase 3, randomised, double-blind, multicenter
global study to determine the efficacy and safety of durvalumab
alone or in combination with oleclumab or monalizumab+ in patients
with unresectable, Stage III NSCLC who have not progressed on
definitive, platinum-based CRT.
The first patient has been dosed in April 2022. The PACIFIC-9
Phase 3 trial is now looking to recruit patients across more than
200 centers in the coming months.
Stage III NSCLC:
In 2020, an estimated 2.2 million people were diagnosed with
lung cancer worldwide1. Lung cancer is broadly split into NSCLC and
small cell lung cancer, with 80-85% classified as NSCLC.2,3,4 Stage
III NSCLC represents approximately one quarter of NSCLC
incidence5.
Stage III (locally advanced) NSCLC is commonly divided into
three subcategories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally. In contrast to Stage IV, when cancer has
spread (metastasised), the majority of Stage III patients are
currently treated with curative intent2,6.
The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours2,5.
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 antibodies7.
The ongoing development for monalizumab is focused on
investigating monalizumab in various combination strategies in
different malignancies, including the Phase 2 NeoCOAST trial in the
neoadjuvant early-stage setting.
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 trial, 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 will 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.
________________________ 1 World Health Organization.
International Agency for Research on Cancer. Lung Fact Sheet.
Available at
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed September 2021. 2 Provencio M, et al. Inoperable Stage III
Non-Small Cell Lung Cancer: Current Treatment and Role Of
Vinorelbine. J Thorac Dis. 2011;3:197-204. 3 Cheema PK, et al.
Perspectives on Treatment Advances for Stage III Locally Advanced
Unresectable Non-Small-Cell Lung Cancer. Curr Oncol.
2019;26(1):37–42. 4 LUNGevity Foundation. Types of Lung Cancer.
Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed September 2021. 5 EpiCast Report: NSCLC Epidemiology
Forecast to 2025. GlobalData. 2016. 6 ASCO. Cancer.net. Lung Cancer
– Non-Small Cell. Available at
https://www.cancer.net/cancer-types/lung-cancer/view-all. Accessed
September 2021. 7 André et al, Cell 2018
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220428006062/en/
Investors and Media
Innate Pharma Henry Wheeler Tel.: +33 484 90 32 88
Henry.wheeler@innate-pharma.fr ATCG Press Marie Puvieux
(France) Tel.: +33 (0)9 81 87 46 72
innate-pharma@atcg-partners.com
Innate Pharma (EU:IPH)
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