Acquisition adds to Merck’s suite of
clinical programs in response to SARS-CoV-2/COVID-19
Merck will accelerate development of
CD24Fc, a candidate for the treatment of patients with
severe and critical COVID-19
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and OncoImmune, a privately-held, clinical-stage
biopharmaceutical company, today announced that the companies have
entered into a definitive agreement pursuant to which Merck,
through a subsidiary, will acquire all outstanding shares of
OncoImmune for an upfront payment of $425 million in cash. In
addition, OncoImmune shareholders will be eligible to receive
sales-based payments and payments contingent on the successful
achievement of certain regulatory milestones. OncoImmune recently
announced positive top-line findings from an interim efficacy
analysis of a Phase 3 study evaluating its lead therapeutic
candidate CD24Fc for the treatment of patients with severe and
critical COVID-19.
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“Meaningful new therapeutic options are desperately needed for
possibly millions of people around the world who will develop
severe or critical COVID-19 disease,” said Dr. Roger M. Perlmutter,
President Merck Research Laboratories. “Recent clinical
investigations support the view that CD24Fc may provide benefit
beyond standard of care therapy for COVID-19 patients requiring
oxygen support, and hence will represent an important addition to
the Merck pipeline of investigational medicines and vaccines
designed to address the COVID-19 pandemic.”
Interim analysis of data from 203 participants (75% of the
planned enrollment) reported by OncoImmune indicated that patients
with severe or critical COVID-19 treated with a single dose of
CD24Fc showed a 60% higher probability of improvement in clinical
status, as defined by the protocol, compared to placebo. The risk
of death or respiratory failure was reduced by more than 50%.
Detailed results will be submitted for publication in a
peer-reviewed medical journal.
“Outstanding work by the OncoImmune team has provided compelling
evidence regarding the use of CD24Fc in patients with severe and
critical COVID-19 in our Phase 3 Trial,” said Yang Liu, PhD,
Co-founder and Chief Executive Officer of OncoImmune. “We look
forward to working with the scientists and manufacturing engineers
at Merck as well as regulators as we seek to accelerate the global
development of this potentially important therapy.”
Under the agreement, prior to the completion of the acquisition,
OncoImmune will spin-out certain rights and assets unrelated to the
CD24Fc program to a new entity to be owned by the existing
shareholders of OncoImmune. In connection with the closing of the
acquisition, Merck will invest $50 million, and become a minority
shareholder, in the new entity.
The closing of the acquisition, which is subject to approval
under the Hart-Scott-Rodino Antitrust Improvements Act and other
customary conditions, is expected before the end of 2020.
OncoImmune was represented by Goodwin Procter LLP as legal
advisor and Guggenheim Securities as financial advisor.
About SAC-COVID Phase 3 Trial
The SAC-COVID Phase 3 clinical trial (NCT04317040) is a
randomized, double blind, placebo-controlled trial designed to
evaluate the safety and efficacy of CD24Fc in hospitalized patients
with COVID-19 requiring oxygen support, including those requiring
supplemental oxygen, high flow oxygen, and mechanical ventilation.
Participants were randomly assigned into two arms receiving either
standard of care plus a single dose of CD24Fc via an intravenous
infusion on Day 1 or standard of care plus placebo on Day 1. The
multi-center trial was initiated in April 2020 and had enrolled 243
patients when the trial was closed to enrollment in September
2020.
About CD24Fc
OncoImmune’s lead product is CD24Fc, a first-in-class
recombinant fusion protein that targets the innate immune system.
Prior to the Phase 3 clinical trial for COVID-19 patients, CD24Fc
has been studied for safety in healthy volunteers and in Phase 2
clinical trials for the prevention of graft versus host disease
(GVHD) following hematopoietic stem cell transplantation in
patients with leukemia. A pivotal Phase 3 clinical trial
(NCT04095858) for prophylaxis of GVHD has been initiated
nationwide.
About Merck’s ongoing Commitment to COVID-19
Merck has been committed to developing an effective response to
COVID-19 since the early stage of the pandemic and is exploring
multiple paths to advance the understanding of SARS-CoV-2
infection. In collaboration with Ridgeback Biotherapeutics, Merck
is evaluating molnupiravir, an investigational orally available
anti-viral candidate, in two Phase 2/3 trials, for the treatment of
patients with COVID-19 in both the outpatient and inpatient
settings.The company is also conducting clinical trials to evaluate
two SARS-CoV-2/COVID-19 vaccine candidates: V590, being developed
through a collaboration with IAVI, which utilizes a recombinant
vesicular stomatitis vector, and V591 which uses a measles virus
vector-based platform.
About OncoImmune
OncoImmune is a privately-held, clinical-stage biopharmaceutical
company that is actively engaged in the discovery and development
of novel biopharmaceuticals for the treatment of cancer and
autoimmune disease.
The company’s lead therapeutic candidate CD24Fc has a novel
mechanism of action that has potential applications to a number of
inflammatory diseases and has shown good safety and tolerability in
a Phase 1 clinical trial in healthy volunteers. Clinical activity
has been observed in two Phase 2 trials in GVHD and the Phase 3
trial in COVID-19. In addition to CD24Fc, OncoImmune has a rich
pipeline of immuno-oncology candidates that will be the focus of
the new spinout. OncoImmune has initiated a Phase 1 clinical trial
evaluating a novel CTLA-4 antibody candidate that selectively
eliminates immune suppressive regulatory T cells in the tumor
microenvironment while preserving their physiological function to
protect host against autoimmune diseases (NCT04140526). Visit
www.oncoimmune.com.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the recent global outbreak of novel coronavirus
disease (COVID-19); the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing
difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of
the company’s patents and other protections for innovative
products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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Merck Media:
Pam Eisele +1 (267) 305-3558
Patrick Ryan +1 (973) 275-7075
Merck Investors:
Peter Dannenbaum +1 (908) 740-1037
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OncoImmune Media:
Helen Schiltz +1 (240) 426-5517
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