- SAR443579/IPH6101, ANKET® platform lead asset, is a
first-in-class NKp46/CD16-based NK cell engager targeting CD123
from a joint research collaboration between Innate Pharma and
Sanofi, under development by Sanofi
- SAR443579 induced clinical benefit in patients with R/R AML
with 5 complete remissions (4 CR / 1 CRi) achieved at 1 mg/kg, and
was well tolerated up to doses of 6 mg/kg
- SAR443579 demonstrated durable responses with two responders
remaining in remission beyond 8.8 and 12.2 months of
treatment
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) announced today that the
updated efficacy and safety results from an open-label,
first-in-human, Phase 1/2 dose-escalation study of SAR443579 /
IPH6101, an investigational CD123 targeting NKp46/CD16-based
Natural Killer Cell Engager (NKCE) from a joint research
collaboration between Innate Pharma and Sanofi were shared in a
poster presentation at the American Society of Hematology 2023
Annual Meeting in San Diego, California. The study, run by Sanofi,
tests SAR443579 as a monotherapy for the treatment of blood cancers
with high unmet needs, including relapsed or refractory acute
myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia
(B-ALL) and high-risk myelodysplasia (HR-MDS). SAR443579 has FDA
Fast Track Designation for the treatment of acute myeloid
leukemia.
As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across
8 dose levels between 10 – 6000 μg/kg/dose were available for
analysis. Patients had received a median of 2.0 (1.0 – 10.0) prior
lines of treatment with 13 patients (30.2%) reporting prior
hematopoietic stem cell transplantation and 36 patients (83.7%)
with prior exposure to venetoclax. At the highest dose of 1000
μg/kg QW, 5/15 (33.3%) patients with AML achieved a CR (4 CR / 1
CRi)1. SAR443579 was well tolerated up to 6000 μg/kg QW with
observed clinical benefit in patients with R/R AML, in line with
the predicted favorable safety profile.
“We are pleased to see that SAR443579 continues to show
promising durable clinical efficacy with now 5 complete remissions
along a favorable safety profile in this Phase 1/2 dose escalation
study in various blood cancers,” says Sonia Quaratino, Chief
Medical Officer of Innate Pharma. “We look forward to continue
to advance the development of multi-specific NK Cell Engagers for
the treatment of cancer with our ANKET platform® and continuing our
partnership with Sanofi.”
“Sanofi is pleased to share these emerging results from our
study of SAR443579,” states Peter Adamson, Global Development
Head, Oncology, Sanofi. “We believe this investigational NK
cell engager may be important to patients with AML who, too often,
have limited therapeutic options available to them. Our updated
results help drive Sanofi R&D teams around the world to
continue efforts to develop impactful treatments for diseases with
high unmet medical needs.”
1 CR: complete remission; CRi: CR with incomplete hematological
recovery
About ANKET® ANKET® (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.
This versatile, fit-for-purpose technology is creating an
entirely new class of molecules to induce synthetic immunity
against cancer.
About the Innate-Sanofi research collaboration and licensing
agreements The Company has a research collaboration and license
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 2016 research collaboration and license
agreement, Sanofi is responsible for the development, manufacturing
and commercialization of products resulting from the research
collaboration, which includes IPH6101/SAR’579 (Trifunctional
anti-CD123 NKp46xCD16 NK cell engager) and IPH6401/SAR’514
(Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of
the 2016 agreement, Innate Pharma is eligible to up to €400m in
development and commercial milestone payments as well as royalties
on net sales.
As part of the license agreement entered in December 2022,
Sanofi licensed IPH62 and has the option for two additional
targets. Under the terms of the 2022 agreement, Innate Pharma is
eligible to up to €1.35bn total in preclinical, clinical,
regulatory and commercial milestones plus royalties on potential
net sales.
About Innate Pharma Innate Pharma S.A. is a global,
clinical-stage biotechnology company developing immunotherapies for
cancer patients. Its innovative approach aims to harness the innate
immune system through therapeutic antibodies and its ANKET®
(Antibody-based NK cell Engager
Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab,
developed in advanced form of cutaneous T cell lymphomas and
peripheral T cell lymphomas, monalizumab developed with AstraZeneca
in non-small cell lung cancer, as well as ANKET® multi-specific NK
cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical
companies such as Sanofi and AstraZeneca, as well as leading
research institutions, to accelerate innovation, research and
development for the benefit of patients.
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 and
follow us on Twitter and LinkedIn.
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 and the Company’s continued
ability to raise capital to fund its development. 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, 2022,
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/20231210199351/en/
For additional information, please contact: Investors
Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90
32 88 Henry.wheeler@innate-pharma.fr Media Relations
NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu
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