Agios Provides Update on 2016 Collaboration Agreement with Celgene, a Wholly Owned Subsidiary of Bristol Myers Squibb
March 25 2020 - 4:01PM
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today provided an update
on its 2016 collaboration agreement with Celgene Corporation, a
wholly owned subsidiary of Bristol Myers Squibb Company. Celgene
has formally declined to exercise its opt-in right for AG-270, a
first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor
development candidate currently in a Phase 1 study in combination
with taxane-based therapy as a potential treatment for
methylthioadenosine phosphorylase (MTAP)-deleted non-small cell
lung cancer and pancreatic cancer. In addition, the research term
of the companies’ metabolic immuno-oncology collaboration, focused
on altering the metabolic state of immune cells to enhance the
body's immune response to cancer, will conclude at the end of the
initial four-year period in May 2020. There is one undisclosed,
ongoing metabolic immuno-oncology research program that Celgene may
designate for continued development within sixty days following the
end of the research term; if it does so, Celgene would have an
opt-in right for this program through the end of Phase 1 dose
escalation.
“We are grateful to Celgene, and now Bristol Myers Squibb, for
their longstanding partnership, which has enabled important
research and clinical development focused on the advancement of
potential innovative treatment approaches for patients with
cancer,” said Jackie Fouse, Ph.D., chief executive officer at
Agios. “We are now evolving our relationship to enable both
companies to advance our respective priorities with full strategic
flexibility.”
“We are proud of the work our scientists have done to
significantly advance knowledge in the field of metabolic
immuno-oncology, and through these efforts we have built
capabilities now being applied across multiple research programs,”
said Bruce Car, Ph.D., chief scientific officer at Agios. “We will
leverage the insights gained under the Celgene collaboration to
continue our research efforts in this area in a strategic and
targeted manner. Moving forward, Agios retains full rights to the
output of our discovery engine and can optimize our allocation of
resources as we strive to discover drug candidates with the
potential to improve the lives of patients with cancer and rare
genetic diseases.”
About the MAT2A Inhibitor AG-270 Agios’
first-in-class MAT2A inhibitor, AG-270, was part of a 2016 global
research collaboration agreement with Celgene. Under the terms
of the agreement, Celgene had an opt-in right on the program up
through the end of Phase 1 dose escalation for at least a $30
million fee.
As described in a 2016 Cell Reports publication, Agios
discovered that MAT2A is a component of a novel pathway which, when
inhibited, results in robust anti-tumor activity in MTAP-deleted
tumors in animal models. Further preclinical studies demonstrated
that the effects of AG-270 downstream of MAT2A inhibition include
effects on mitosis, which creates the potential for enhanced
vulnerability to antimitotics, including the clinically-applicable
taxanes.
The first data from the single agent dose-escalation arm of the
Phase 1 study of AG-270 in MTAP-deleted tumors were presented at
the 2019 AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics, which demonstrated that AG-270
induces reductions in the biomarkers of MAT2A inhibition, notably
plasma concentrations of S-adenosylmethionine (SAM) and tumor
levels of symmetrically demethylated arginine (SDMA), at well
tolerated doses. The Phase 1 trial is ongoing in cohorts exploring
the safety and preliminary efficacy of AG-270 in combination with
taxanes in non-small cell lung cancer and pancreatic cancer.
About the 2016 Metabolic Immuno-Oncology
AgreementIn May 2016, Agios and Celgene entered into the
2016 Metabolic Immuno-Oncology Agreement, a global strategic
collaboration focused on discovering, developing and
commercializing novel therapies based on Agios’ innovative cellular
metabolism research platform.
There is one ongoing research program that Celgene may designate
for continued development within 60 days following the end of the
initial four-year research term, which expires on May 17, 2020, by
paying an $8 million designation fee. Agios may conduct further
research and preclinical and clinical development activities on
this program, at its expense, through the completion of an initial
Phase 1 dose escalation study, at which point Celgene has an opt-in
right for this program for at least a $30 million fee.
About the Agios/Celgene IDH ProgramIn 2010,
Agios and Celgene entered into a collaboration agreement focused on
cancer metabolism. Under the terms of the agreement, Celgene has
worldwide development and commercialization rights for IDHIFA®
(enasidenib). Agios continues to conduct certain clinical
development activities within the IDHIFA® development program and
is eligible to receive reimbursement for those development
activities and up to $80 million in remaining milestone payments,
and royalties on any net sales. Celgene and Agios are currently
co-commercializing IDHIFA® in the U.S. Celgene will reimburse Agios
for costs incurred for its co-commercialization efforts.
About AgiosAgios is focused on discovering and
developing novel investigational medicines to treat malignant
hematology, solid tumors and rare genetic diseases through
scientific leadership in the field of cellular metabolism. In
addition to an active research and discovery pipeline across these
three therapeutic areas, Agios has two approved oncology precision
medicines and multiple first-in-class investigational therapies in
clinical and/or preclinical development. For more information,
please visit the company's website at www.agios.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding Agios’ plans, strategies and expectations for its and its
collaborator’s preclinical, clinical and commercial advancement of
its drug development programs including AG-270; developments
regarding its 2016 collaboration agreement with Celgene; and the
potential benefit of its strategic plans and focus. The words
“anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,”
“potential,” “possible,” “strategy,” “will,” “vision,” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from Agios' current
expectations and beliefs. For example, there can be no guarantee
that any product candidate Agios or its collaborators is developing
will successfully commence or complete necessary preclinical and
clinical development phases, or that development of any of Agios'
product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios' business will
result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other important factors, including: Agios' results of
clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by the
U.S. FDA, the EMA or other regulatory authorities, investigational
review boards at clinical trial sites and publication review
bodies; Agios' ability to obtain and maintain requisite regulatory
approvals and to enroll patients in its planned clinical trials;
unplanned cash requirements and expenditures; competitive factors;
Agios' ability to obtain, maintain and enforce patent and other
intellectual property protection for any product candidates it is
developing; Agios' ability to maintain key collaborations; and
general economic and market conditions. These and other risks are
described in greater detail under the caption "Risk Factors"
included in Agios’ public filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Agios expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Contacts
Investors:Holly Manning, 617-844-6630Director,
Investor RelationsHolly.Manning@agios.com
Media:Jessica Rennekamp, 857-209-3286Associate
Director, Corporate CommunicationsJessica.Rennekamp@agios.com
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