— ISM3091 is a highly selective,
orally bioavailable small molecule inhibitor of USP1 identified
through Insilico Medicine’s artificial intelligence (AI) platform,
with potent activity in BRCA-mutated tumor models —
— In April 2023, the U.S. Food and
Drug Administration (FDA) cleared Insilico’s Investigational New
Drug application (IND) for ISM3091 in patients with solid tumors
—
Exelixis, Inc. (Nasdaq: EXEL) and Insilico Medicine (“Insilico”)
today announced that the companies have entered into an exclusive
license agreement granting Exelixis global rights to develop and
commercialize ISM3091, a potentially best-in-class small molecule
inhibitor of USP1, which has emerged as a synthetic lethal target
in the context of BRCA-mutated tumors.
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Under the terms of the agreement, Insilico granted Exelixis an
exclusive, worldwide license to develop and commercialize ISM3091,
and other USP1-targeting compounds, in exchange for an upfront
payment to Insilico of $80 million anticipated in the third quarter
2023. Insilico is also eligible to receive future development,
commercial, and sales-based milestone payments, as well as tiered
royalties on net sales.
“ISM3091 represents a potentially best-in-class approach to
inhibiting USP1, an important oncology target with broad
applicability in BRCA-mutant tumors,” said Dana Aftab, Ph.D.,
Executive Vice President, Discovery and Translational Research and
Chief Scientific Officer, Exelixis. “We believe preclinical data on
ISM3091’s potent anti-tumor activity, tolerability, and
pharmacokinetics set the compound apart from competing USP1
inhibitors and make it an important addition to Exelixis’ growing
clinical-stage pipeline. Following the FDA’s clearance of
Insilico’s IND earlier this spring, we’re looking forward to
accelerating phase 1 trial enrollment.”
“ISM3091 is the third clinical-stage program made possible by
Chemistry42, Insilico Medicine’s generative AI platform for small
molecule drug discovery,” said Alex Zhavoronkov, Ph.D., founder and
CEO of Insilico Medicine. “The compound’s novel structure,
anti-tumor activity, and excellent drug-like properties give it
significant potential as a differentiated program directed at
BRCA-mutant tumors, which include forms of ovarian, prostate, and
breast cancer. This program attracted significant interest from
multiple potential partners in the pharmaceutical industry, but we
were most impressed by the level of technical expertise and
development and commercial capabilities of Exelixis. With a track
record of commercial and clinical development success in oncology,
Exelixis is the best partner to take ISM3091 forward, and we’re
excited to see the program take flight as a component of the
company’s pipeline behind cabozantinib, its global oncology
franchise.”
USP1 facilitates DNA damage repair by removing ubiquitin from
multiple substrates including proteins that stabilize the
replication fork. A small molecule discovered using Insilico
Medicine’s generative AI platform with extensive multiparameter
optimization capabilities, ISM3091 was designed to inhibit the
activity of USP1. In preclinical experiments, ISM3091 was found to
be potently efficacious against multiple tumor cell lines and in
vivo models with BRCA mutations, as well as in homologous
recombination DNA repair (HRR)-proficient models, both as a single
agent and in combination with PARP inhibitors. It is also well
tolerated in different species with a high margin of safety.
Insilico disclosed select data in a poster presentation at the
American Association for Cancer Research Annual Meeting in April
2023. On April 17, 2023, the FDA cleared the initial IND for
ISM3091 for the treatment of patients with solid tumors.
About Insilico Medicine
Insilico Medicine, a global clinical stage biotechnology company
powered by generative AI, is connecting biology, chemistry, and
clinical trials analysis using next-generation AI systems. The
company has developed AI platforms that utilize deep generative
models, reinforcement learning, transformers, and other modern
machine learning techniques for novel target discovery and the
generation of novel molecular structures with desired properties.
Insilico Medicine is developing breakthrough solutions to discover
and develop innovative drugs for cancer, fibrosis, immunity,
central nervous system diseases, infectious diseases, autoimmune
diseases, and aging-related diseases. www.insilico.com
About Exelixis
Exelixis is a globally ambitious oncology company innovating
next-generation medicines and regimens at the forefront of cancer
care. Powered by bi-coastal centers of discovery and development
excellence, we are rapidly evolving our product portfolio to target
an expanding range of tumor types and indications with our
clinically differentiated pipeline of small molecules,
antibody-drug conjugates and other biotherapeutics. This
comprehensive approach harnesses decades of robust investment in
our science and partnerships to advance our investigational
programs and extend the impact of our flagship commercial product,
CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific
pursuit to create transformational treatments that give more
patients hope for the future. For information about the company and
its mission to help cancer patients recover stronger and live
longer, visit www.exelixis.com, follow @ExelixisInc on X, like
Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
belief that ISM3091 is a potentially best-in-class small molecule
inhibitor of USP1 with broad applicability in BRCA-mutated tumors,
and that ISM3091’s anti-tumor activity, tolerability and
pharmacokinetics differentiate it from competing USP1 inhibitors
and make it an important addition to Exelixis’ growing
clinical-stage pipeline; Exelixis’ immediate and future financial
and other obligations under the exclusive license agreement with
Insilico, including the anticipated timing of Exelixis’ payment of
an $80 million upfront fee to Insilico; Exelixis’ plans to
accelerate phase 1 trial enrollment; and Exelixis’ scientific
pursuit to create transformational treatments that give more
patients hope for the future. Any statements that refer to
expectations, projections or other characterizations of future
events or circumstances are forward-looking statements and are
based upon Exelixis’ current plans, assumptions, beliefs,
expectations, estimates and projections. Forward-looking statements
involve risks and uncertainties. Actual results and the timing of
events could differ materially from those anticipated in the
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation: the level of
costs associated with Exelixis’ commercialization, research and
development, in-licensing or acquisition of product candidates, and
other activities; uncertainties inherent in the drug discovery and
product development process; Exelixis’ dependence on its
relationship with Insilico, including Insilico’s adherence to its
obligations under the exclusive license agreement; complexities and
the unpredictability of the regulatory review and approval
processes in the U.S. and elsewhere; Exelixis’ and Insilico’s
continuing compliance with applicable legal and regulatory
requirements; Exelixis’ and Insilico’s ability to protect their
respective intellectual property rights; market competition;
changes in economic and business conditions; and other factors
affecting Exelixis and its product pipeline discussed under the
caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission (SEC) on August
1, 2023 and Annual Report on Form 10-K filed with the SEC on
February 7, 2023, and in Exelixis’ future filings with the SEC. All
forward-looking statements in this press release are based on
information available to Exelixis as of the date of this press
release, and Exelixis undertakes no obligation to update or revise
any forward-looking statements contained herein, except as required
by law.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks.
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Exelixis Investors Contact: Susan Hubbard EVP, Public
Affairs & Investor Relations Exelixis, Inc. 650-837-8194
shubbard@exelixis.com
Exelixis Media Contact: Hal Mackins For Exelixis, Inc.
415-994-0040 hal@torchcommunications.com
Insilico Media Contact: Brita Belli Head of PR Insilico
Medicine 475-225-0843 brita@insilico.com
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