- Agreement builds on and complements Daiichi Sankyo and Merck’s
shared commitment to develop novel medicines for patients with
cancer
- Daiichi Sankyo and Merck to co-develop and co-commercialize
MK-6070, an investigational delta-like ligand 3 (DLL3) targeting
T-cell engager, worldwide except for Japan where Merck retains
exclusive rights
Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD
outside of the United States and Canada, have expanded their
existing global co-development and co-commercialization agreement
for three investigational DXd antibody drug conjugates to include
Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3)
targeting T-cell engager. The companies will jointly develop and
commercialize MK-6070 worldwide, except in Japan where Merck will
maintain exclusive rights. Merck will be solely responsible for
manufacturing and supply for MK-6070.
MK-6070 is a T-cell engager targeting DLL3, an inhibitory
canonical Notch ligand that is expressed at high levels in small
cell lung cancer (SCLC) and neuroendocrine tumors, currently being
evaluated in a phase 1/2 clinical trial. The companies are planning
to evaluate MK-6070 in combination with ifinatamab deruxtecan
(I-DXd) in certain patients with SCLC, as well as other potential
combinations. Merck obtained MK-6070 through its acquisition of
Harpoon Therapeutics.
“Expanding our oncology pipeline with a DLL3 T-cell engager
further supports Daiichi Sankyo’s strategy to create new standards
of care for patients with cancer worldwide,” said Ken Takeshita,
MD, Global Head, R&D, Daiichi Sankyo. “We look forward to
continuing our relationship with Merck with the addition of MK-6070
as it provides potential synergies with our established antibody
drug conjugate collaboration, particularly ifinatamab deruxtecan,
and demonstrates our shared commitment to advancing new medicines
for patients.”
“Small cell lung cancer is an aggressive, fast-growing form of
lung cancer and new treatment approaches are urgently needed,” said
Dean Y. Li, MD, PhD, President, Merck Research Laboratories. “We
are pleased to build upon our collaboration with Daiichi Sankyo and
look forward to evaluating the combination of MK-6070 and
ifinatamab deruxtecan as a novel two-pronged approach targeting the
underlying biology of small cell lung cancer along with other forms
of cancer.”
Financial Highlights Under the terms of the agreement,
Merck will receive an upfront cash payment of $170 million and has
also satisfied a contingent quid obligation from the original
collaboration agreement. The companies will share R&D and
commercialization expenses as well as profits worldwide, except for
Japan where Merck retains exclusive rights and Daiichi Sankyo
receives a royalty based on sales. R&D expenses related to
MK-6070 in combination with ifinatamab deruxtecan will be shared in
a manner consistent with the original agreement for ifinatamab
deruxtecan. Merck will generally record sales for MK-6070
worldwide.
About DLL3 Delta-like ligand 3 (DLL3), a Notch inhibitory
ligand, is highly expressed on SCLC and other neuroendocrine tumors
such as melanoma, small cell bladder cancer and metastatic
castration resistant prostate cancer and is minimally expressed in
normal tissues.1 DLL3 is a promising therapeutic target where
multiple treatment approaches are being explored.1, 2
About MK-6070 MK-6070 is an investigational DLL3 directed
tri-specific T-cell engager currently being evaluated in a phase
1/2 clinical trial as a monotherapy in certain patients with
advanced cancers associated with expression of DLL3 and in
combination with atezolizumab in certain patients with SCLC. The
U.S. Food and Drug Administration (FDA) granted Orphan Drug
Designation to MK-6070 for the treatment of SCLC in March 2022.
About the Daiichi Sankyo and Merck Collaboration Daiichi
Sankyo and Merck (known as MSD outside of the United States and
Canada) entered into a global collaboration in October 2023 to
jointly develop and commercialize patritumab deruxtecan (HER3-DXd),
ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd),
except in Japan where Daiichi Sankyo will maintain exclusive
rights. Daiichi Sankyo is solely responsible for manufacturing and
supply.
About Daiichi Sankyo Daiichi Sankyo is an innovative
global healthcare company contributing to the sustainable
development of society that discovers, develops and delivers new
standards of care to enrich the quality of life around the world.
With more than 120 years of experience, Daiichi Sankyo leverages
its world-class science and technology to create new modalities and
innovative medicines for people with cancer, cardiovascular and
other diseases with high unmet medical needs. For more information,
please visit www.daiichisankyo.com.
Merck’s Focus on Cancer Every day, we follow the science
as we work to discover innovations that can help patients, no
matter what stage of cancer they have. As a leading oncology
company, we are pursuing research where scientific opportunity and
medical need converge, underpinned by our diverse pipeline of more
than 25 novel mechanisms. With one of the largest clinical
development programs across more than 30 tumor types, we strive to
advance breakthrough science that will shape the future of
oncology. By addressing barriers to clinical trial participation,
screening and treatment, we work with urgency to reduce disparities
and help ensure patients have access to high-quality cancer care.
Our unwavering commitment is what will bring us closer to our goal
of bringing life to more patients with cancer. For more
information, visit https://www.merck.com/research/oncology/.
About Merck At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on X (formerly Twitter),
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
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
candidates that the candidates 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 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 Annual
Report on Form 10-K for the year ended December 31, 2023 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
References: 1 Owen D, et al. Journal of Hematology &
Oncology. 2019; 12,61 2 Rudin C, et al. Journal of Hematology &
Oncology. 2023; 16,66
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Daiichi Sankyo
Media Contacts:
Global/US Media: Jennifer Brennan Daiichi Sankyo, Inc.
jennifer.brennan@daiichisankyo.com (908) 900-3183
Japan Media: DS-PR@daiichisankyo.co.jp
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
Merck
Media: Robert Josephson Robert.josephson@merck.com (203)
914-2372
Investors: Peter Dannenbaum peter.dannenbaum@merck.com
(732) 594-1579
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