- Partner Sanofi advances IPH6101/ SAR443579, a novel
NKp46/CD16-based, CD123 targeted NK cell engager, to first-in-human
clinical trial in relapsed/refractory AML, B-ALL or HR-MDS
- First molecule from Innate’s multi-specific NK cell engager
platform, ANKETTM, to progress to the clinic
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced that the
first patient was dosed in a Phase 1/2 clinical trial
(NCT05086315), evaluating IPH6101/SAR443579, the first
NKp46/CD16-based NK cell engager, in patients with relapsed or
refractory acute myeloid leukemia (R/R AML), B-cell acute
lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic
syndrome (HR-MDS).
The purpose of the dose escalation and dose expansion study,
which is sponsored by Sanofi, is to evaluate the safety,
pharmacokinetics, pharmacodynamics and initial clinical activity of
IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various
CD123-expressing hematological malignancies.
This trial is supported by positive pre-clinical results
presented at the Society for Immunotherapy of Cancer (SITC) 2021
Congress, which demonstrated the CD123-targeted molecule’s potent
antitumor activity against AML, including evidence supporting
greater anti-leukemia activity compared with an anti-CD123
antibody. IPH6101/SAR443579 had sustained pharmacodynamic effects
in non-human primates, combining efficient depletion of
CD123-expressing cells with minor systemic cytokine release in
comparison to T-cell engagers. As expected, it also had a favorable
safety profile.
“We’re pleased with the initiation of the clinical trial for
IPH6101/SAR443579, which is the first ANKETTM asset to enter the
clinic. ANKETTM is our new multi-specific NK cell engager platform,
which has the potential to engage NK cells through NKp46 and CD16,
and more broadly, generate an entirely new class of molecules to
induce synthetic immunity against cancer,” said Joyson Karakunnel,
MD, MSc, FACP, Chief Medical Officer of Innate Pharma. “We look forward to continuing to advance
this platform given the critical role NK cells play in the cancer
immunity cycle.”
The start of the trial has triggered a milestone payment from
Sanofi to Innate, which is part of a previously announced research
collaboration with Sanofi. Under the agreement, the companies
collaborate on the generation and evaluation of up to two
bispecific ANKETs, using technology from Innate and Sanofi’s
proprietary bispecific antibody formats as well as tumor targets.
The companies are currently working on the second research program
under the agreement.
More information about the Phase 1/2 trial can be found
here.
About ANKETTM:
ANKETTM (Antibody-based NK cell Engager
Therapeutics) is Innate's proprietary platform for
developing next-generation, multi-specific natural killer (NK) cell
engagers to treat certain types of cancer. The Company’s latest
innovation, its tetra-specific ANKETTM molecule, is the first NK
cell engager technology to engage two NK cell activating receptors
(NKp46 and CD16), a tumor antigen and the interleukin-2 receptor
(by an IL-2 variant, IL-2v), via a single molecule. This molecule
leverages the advantages of harnessing NK cell effector functions
against cancer cells and also provides proliferation and activation
signals targeted to NK cells.
In pre-clinical studies, Innate's tri-1 and tetra-specific
ANKETTM technologies promote potent NK cell activation,
cytotoxicity and efficient control of tumor growth in pre-clinical
models. This versatile fit-for-purpose technology is creating an
entirely new class of molecules to induce synthetic immunity
against cancer.
About IPH6101/SAR443579:
In the first research program of the Sanofi collaboration,
IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using
Innate’s proprietary multi-specific antibody format, has shown
antitumor activity in pre-clinical models, including supportive
pharmacokinetic/pharmacodynamic (PK/PD) and safety data in
non-human primate studies leading to its selection as a drug
candidate for development.
About the Innate-Sanofi agreement:
The Company has a research collaboration and licensing agreement
with Sanofi to apply Innate’s proprietary technology to the
development of innovative multi-specific antibody formats engaging
NK cells through the activating receptors NKp46 and CD16 to kill
tumor cells.
Under the terms of the license agreement, Sanofi will be
responsible for the development, manufacturing and
commercialization of products resulting from the research
collaboration. Innate Pharma will be eligible to up to €400m in
development and commercial milestone payments as well as royalties
on net sales.
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 Ticker code
LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
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, 2020, 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 Gauthier et al., Cell 2019
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version on businesswire.com: https://www.businesswire.com/news/home/20211215005894/en/
Investors Innate
Pharma Henry Wheeler
Tel.: +33 761 88 38 74
Henry.wheeler@innate-pharma.fr
Media Innate Pharma
Tracy Rossin (Global/US) Tel.: +1 240 801 0076
Tracy.Rossin@innate-pharma.com ATCG Press Marie Puvieux
(France) Tel.: +33 (0)9 81 87 46 72
innate-pharma@atcg-partners.com
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