Bristol-Myers Squibb Company (NYSE: BMY) and Agenus Inc.
(NASDAQ: AGEN) today announced that they have entered into a
definitive agreement under which Bristol Myers Squibb will be
granted a global exclusive license to Agenus’ proprietary
bispecific antibody program, AGEN1777, that blocks TIGIT and a
second undisclosed target. AGEN1777 is an Fc-enhanced antibody in
late preclinical development designed to target major inhibitory
receptors expressed on T and NK cells to improve anti-tumor
activity. In preclinical studies this approach has shown
significant potential in tumor models where anti-PD-1 or anti-TIGIT
monospecific antibodies alone are ineffective.
Under the agreement, Bristol Myers Squibb will become solely
responsible for the development and any subsequent
commercialization of AGEN1777 and its related products worldwide.
Agenus will receive a $200 million upfront payment and up to $1.36
billion in development, regulatory and commercial milestones in
addition to tiered double-digit royalties on net product sales.
Agenus will retain options to conduct clinical studies under the
development plan, to conduct combination studies with certain other
Agenus pipeline assets, and also, upon commercialization, to
co-promote AGEN1777 in the US. The agreement is subject to
clearance under the Hart-Scott-Rodino Antitrust Improvements Act of
1976.
Agenus expects to file an Investigational New Drug (“IND”)
application for the development of AGEN1777 with the U.S. Food and
Drug Administration in the second quarter of 2021. Bristol Myers
Squibb intends to advance the research and development of AGEN1777
in immuno-oncology (“I-O”) for high priority tumor indications
including non-small cell lung cancer.
“AGEN1777’s differentiated mechanism of action provides the
potential for potent anti-tumor activity; catalyzing our clinical
TIGIT strategy aimed at serving more patients with unmet needs in
cancer,” said Debbie Law, D.Phil., Senior Vice President, Head of
Tumor Microenvironment Thematic Research Center, Bristol Myers
Squibb. “We look forward to working with Agenus to develop this
important therapy as we continue to combat I-O resistance.”
“We are pleased to partner with Bristol Myers Squibb to develop
and commercialize AGEN1777. Their stellar record of success in this
area has been an important determinant for our decision to enter
into this transaction,” said Garo Armen, PhD, Chairman and Chief
Executive Officer of Agenus. “Through such transactions we are able
to balance between advancing our portfolio with highly qualified
collaborators, while retaining our other innovations for speedy
development and commercialization by Agenus.”
About AGEN1777
AGEN1777 is a potentially first-in-class bispecific anti-TIGIT
antibody engineered with an enhanced Fc region for high binding
affinity and improved T and NK cell activation.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body’s
immune system to fight cancer. The Company’s vision is to expand
the patient populations benefiting from cancer immunotherapy by
pursuing combination approaches that leverage a broad repertoire of
antibody therapeutics, adoptive cell therapies (through its AgenTus
Therapeutics subsidiary), and proprietary cancer vaccine platforms.
The Company is equipped with a suite of antibody discovery
platforms and a state-of-the-art GMP manufacturing facility with
the capacity to support clinical programs. Agenus is headquartered
in Lexington, MA. For more information, please visit
www.agenusbio.com and our Twitter handle @agenus_bio. Information
that may be important to investors will be routinely posted on our
website and Twitter.
Agenus Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding clinical
development and regulatory plans and timelines related to AGEN1777
and other programs, potential receipt of development, regulatory
and commercial milestones and the potential clinical benefit of
such programs. These forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially. These risks and uncertainties include, among others,
the factors described under the Risk Factors section of our most
recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K
filed with the Securities and Exchange Commission. Agenus cautions
investors not to place considerable reliance on the forward-looking
statements contained in this release. These statements speak only
as of the date of this press release, and Agenus undertakes no
obligation to update or revise the statements, other than to the
extent required by law. All forward-looking statements are
expressly qualified in their entirety by this cautionary
statement.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook
and Instagram.
Bristol Myers Squibb Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products and the license
agreement. All statements that are not statements of historical
facts are, or may be deemed to be, forward-looking statements. Such
forward-looking statements are based on historical performance and
current expectations and projections about our future financial
results, goals, plans and objectives and involve inherent risks,
assumptions and uncertainties, including internal or external
factors that could delay, divert or change any of them in the next
several years, that are difficult to predict, may be beyond our
control and could cause our future financial results, goals, plans
and objectives to differ materially from those expressed in, or
implied by, the statements. These risks, assumptions, uncertainties
and other factors include, among others, that the expected benefits
of, and opportunities related to, the license agreement may not be
realized by Bristol Myers Squibb or may take longer to realize than
anticipated and that Bristol Myers Squibb may fail to discover and
develop any commercially successful product candidates through the
license agreement. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2020, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
Contacts
Bristol Myers Squibb
Media:media@bms.comInvestors:Tim
Power, 609-252-7509, timothy.power@bms.comNina Goworek,
908-673-9711, nina.goworek@bms.com
Agenus
Media:Kimberly Ha, KKH Advisors, 917-291-5744,
kimberly.ha@kkhadvisors.com
Investors:Jan Medina, CFA, Agenus,
781-674-4490, Jan.Medina@agenusbio.com
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