Bristol Myers Squibb (NYSE: BMY) and The Rockefeller University
today announced that they have entered into a definitive agreement
under which Bristol Myers Squibb has been granted a global
exclusive license to develop, manufacture and commercialize
Rockefeller’s novel monoclonal antibody (“mAb”) duo treatment that
neutralizes the SARS-CoV-2 virus for therapy or prevention of
COVID-19.
Despite the increasing availability of the vaccines, there will
continue to be patients who contract COVID-19 and will need
treatment for their infection. This novel treatment is a
combination of two mAbs directed at blocking the SARS-CoV-2 spike
protein and neutralizing the virus. The mAbs have been engineered
to be highly potent and stable, allowing them to last longer in the
bloodstream. Preclinical data suggest that this could enable
effective treatment against multiple variants of the virus using a
low dose subcutaneous administration, which would increase access
to the medicine by eliminating the need for intravenous
infusion.
Ultimately, should the clinical development be successful, these
advantages could potentially help expand access globally, including
to low- and middle-income countries and to communities where
healthcare resources are limited—a goal that both institutions will
jointly work towards.
Phase 1 clinical trials to assess dosing for IV and subcutaneous
formulations, and to assess safety for the mAb duo, were initiated
by Rockefeller in mid-January. Planning is underway with the goal
of moving rapidly to a registrational program following readout of
the phase 1 study taking place at Rockefeller University
Hospital.
“We look forward to continuing to work with The Rockefeller
University in this crucial effort,” said Ho Sung Cho, Ph.D., Senior
Vice President, Discovery Biotherapeutics, Bristol Myers Squibb.
“Bristol Myers Squibb has supported the development and
manufacturing of clinical supplies for Rockefeller to begin the
Phase 1 trial and we are committed to leveraging our capabilities
and resources in an effort to expeditiously develop and bring this
potential treatment to patients and further address the challenges
of the pandemic.”
“The two highly potent antibodies against SARS-CoV-2, discovered
by Rockefeller scientists, have the potential to play an important
role in treating COVID-19 patients,” said Richard P. Lifton,
President, The Rockefeller University. “New treatment options are
urgently needed that treat mild to moderate disease and prevent
development of severe disease in high-risk patients. Our
collaboration with BMS will help us accelerate development
timelines and support rapid delivery to patients.”
Included in the terms of the agreement, Rockefeller is entitled
to receive royalty payments on future sales. Should the clinical
development be successful, Bristol Myers Squibb will work to enable
availability and affordability of this potential treatment to
patients globally.
About SARS-CoV-2 mAb Combo
Rockefeller has discovered two complementary antibodies to the
SARS-CoV-2 spike protein that synergistically neutralize the virus
in vitro and in animal models. The two antibodies have shown
activity against several known SARS-CoV-2 mutants and it is
believed that their co-administration could reduce the possibility
of mutant virus escape. The two antibodies are potentially unique
as pertains to their long half-life in humans and high affinity for
the spike protein. The longer half-life has been enabled by
leveraging Xencor’s Fc engineering technology.
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.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
About The Rockefeller University
The Rockefeller University is the world’s leading biomedical
research university and is dedicated to conducting innovative,
high-impact research to improve the understanding of life for the
benefit of humanity. The university’s unique approach to science,
with only 70 faculty, each selected for pursuit of highly
innovative ideas, has led to many of the world’s most revolutionary
and transformative contributions to biology and medicine. During
Rockefeller’s 120-year history, Rockefeller scientists have won 26
Nobel Prizes, 24 Albert Lasker Medical Research Awards, and 20
National Medals of Science.
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 agreement with
The Rockefeller University. 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
agreement with The Rockefeller University may not be realized by
Bristol Myers Squibb or may take longer to realize than anticipated
and that Rockefeller’s novel monoclonal antibody duo treatment may
not receive regulatory approval for the treatment of COVID-19. 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,
2019, 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.
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Bristol Myers Squibb Media Inquiries: Media@BMS.com
Investors: Tim Power, 609-252-7509, timothy.power@bms.com
Rockefeller University Media Inquiries: Katherine Fenz,
212-327-7913, Katherine.Fenz@rockefeller.edu
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