SAR’579 / IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies
June 08 2023 - 12:00AM
Business Wire
- SAR’579, ANKET® platform lead asset, is a trifunctional
anti-CD123 NKp46×CD16 NK cell engager from a joint research
collaboration between Innate Pharma and Sanofi, now under
development by partner Sanofi.
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) is pleased to share
Sanofi’s news that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation for SAR’579 / IPH6101 for the
treatment of hematological malignancies.
Fast Track Designation is an FDA process designed to facilitate
the development, and expedite the review of, medicines to treat
serious conditions and fill unmet medical need. The FDA created
this process to help deliver important new drugs to patients
earlier, and it covers a broad range of serious illnesses.
SAR’579, ANKET® platform lead asset, is a trifunctional
anti-CD123 NKp46×CD16 NK cell engager from a joint research
collaboration between Innate Pharma and Sanofi, now under
development by partner Sanofi.
“It is promising to see SAR’579 / IPH6101 was granted Fast Track
Designation in the US for the treatment of hematological
malignancies, and congratulate our partner Sanofi on this
milestone,” said Mondher Mahjoubi, Chief Executive Officer of
Innate Pharma. “In addition to the encouraging clinical data
recently presented at the 2023 ASCO Annual Meeting, this FDA Fast
Track Designation further validates the potential of the ANKET®
platform to treat cancer patients with NK Cell Engagers.”
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 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 NKp46×CD16 NK cell engager) and IPH6401/SAR’514
(Trifunctional anti-BCMA NKp46×CD16 NK cell engager). As part of
the 2016 agreement, Innate Pharma will be eligible to up to €400m
in development and commercial milestone payments as well as
royalties on net sales.
Another license agreement was entered in December 2022, which
includes IPH62 and 2 options.
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
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 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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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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