Acquisition Strengthens Merck’s Oncology
Pipeline with VLS-101, an Investigational Antibody-Drug Conjugate
to Treat Hematological Malignancies and Solid Tumors
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and VelosBio Inc. today announced that the companies have
entered into a definitive agreement pursuant to which Merck,
through a subsidiary, will acquire all outstanding shares of
VelosBio for $2.75 billion in cash, subject to certain customary
adjustments. VelosBio is a privately held clinical-stage
biopharmaceutical company committed to developing first-in-class
cancer therapies targeting receptor tyrosine kinase-like orphan
receptor 1 (ROR1). VelosBio’s lead investigational candidate is
VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is
currently being evaluated in a Phase 1 and a Phase 2 clinical trial
for the treatment of patients with hematologic malignancies and
solid tumors, respectively.
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“At Merck, we continue to bolster our growing oncology pipeline
with strategic acquisitions that both complement our current
portfolio and strengthen our long-term growth potential,” said Dr.
Roger M. Perlmutter, president, Merck Research Laboratories.
“Pioneering work by VelosBio scientists has yielded VLS-101, which
in early studies has provided notable evidence of activity in
heavily pretreated patients with refractory hematological
malignancies, including mantel cell lymphoma and diffuse large
B-cell lymphoma.”
In October 2020, VelosBio announced the initiation of a Phase 2
clinical trial (NCT04504916) to evaluate VLS-101 for the treatment
of patients with solid tumors, including patients with
triple-negative breast cancer (TNBC), hormone receptor-positive
and/or HER2-positive breast cancer, and non-squamous non-small-cell
lung cancer (NSCLC). In early clinical trials, VLS-101 demonstrated
a manageable safety profile and early signs of anti-tumor activity.
Results of a Phase 1 clinical trial, to be presented virtually at
the 62nd American Society of Hematology Annual Meeting (Dec. 5-8,
2020), showed that VLS-101 resulted in objective clinical
responses, including complete responses, in 47% (n=7/15) of
patients with mantle cell lymphoma (MCL) and 80% (n=4/5) of
patients with diffuse large B-cell lymphoma. Patients in this Phase
1 trial had been heavily pretreated with other anticancer
medications, and their cancers had failed to respond or had
relapsed after initially responding to these other anticancer
medications. In addition, VelosBio is developing a preclinical
pipeline of next-generation ADCs and bispecific antibodies
targeting ROR1 with the potential to complement VLS-101 by offering
alternative methods of tumor cell killing.
“Merck is a recognized leader in oncology, and this acquisition
reflects the hard work and commitment of all the employees at
VelosBio in advancing the science of ROR1,” said Dave Johnson,
founder and chief executive officer at VelosBio. “We are very
pleased that Merck has recognized the value of our first-in-class
ROR1-directed investigational therapeutics. As part of Merck’s
oncology pipeline, our lead product candidate, VLS-101, is now well
positioned to achieve its maximum potential to benefit appropriate
cancer patients in need.”
The closing of the transaction, which is subject to approval
under the Hart-Scott-Rodino Antitrust Improvements Act and other
customary conditions, is expected by the end of 2020.
Merck was represented by Gibson Dunn & Crutcher LLP as legal
advisor and J.P. Morgan Securities LLC as financial advisor.
VelosBio was represented by Cooley LLP as legal advisor and
Centerview Partners LLC as financial advisor.
About VLS-101
VLS-101 is an investigational ADC comprising a monoclonal
antibody targeting ROR1 that is linked to a chemotherapeutic agent
called monomethyl auristatin E (MMAE). After the antibody binds to
ROR1 on cancer cells, the ADC is designed to enter those cells and
release MMAE to destroy the cancer cells. In mouse models of human
hematologic malignancies and solid tumors, VLS-101 showed robust
antitumor activity. VLS-101 is in clinical development for patients
with previously treated hematologic malignancies and solid tumors.
The U.S. Food and Drug Administration has granted VLS-101 orphan
drug and fast track designations for the treatment of MCL.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
the potential to bring new hope to people with cancer drives our
purpose and supporting accessibility to our cancer medicines is our
commitment. As part of our focus on cancer, Merck is committed to
exploring the potential of immuno-oncology with one of the largest
development programs in the industry across more than 30 tumor
types. We also continue to strengthen our portfolio through
strategic acquisitions and are prioritizing the development of
several promising oncology candidates with the potential to improve
the treatment of advanced cancers. For more information about our
oncology clinical trials, visit www.merck.com/clinicaltrials.
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.
About VelosBio
VelosBio Inc. is a clinical-stage biopharmaceutical company
committed to transforming the lives of patients with cancer by
developing first-in-class therapies targeting ROR1. Its lead
candidate, VLS-101, is a ROR1-directed ADC being developed for
patients with hematologic malignancies and solid tumors. The
company is utilizing its ROR1-targeting antibody-based technology
to develop a pipeline of ADCs and bispecific antibody product
candidates for the treatment of hematologic malignancies and solid
tumors. VelosBio is headquartered in San Diego. For more
information, please visit www.velosbio.com.
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
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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
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actual results may differ materially from those set forth in the
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Risks and uncertainties include but are not limited to, general
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including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
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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;
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future events or otherwise. Additional factors that could cause
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Merck Media: Pamela Eisele (267) 305-3558
Kristen Drake (908) 740-6179
VelosBio Media: Kimberly Ha (917) 291-5744
Merck Investors: Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
VelosBio Investors: Enoch Kariuki, PharmD (786) 442-5554
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