USA — Merck & Co. has exercised a US$250-million option with Moderna to jointly develop and commercialize personalized mRNA cancer vaccine candidates.
Merck & Co. will pay Moderna US$250 million to exercise its option for personalized cancer vaccines, including mRNA-4157/V940, under the terms of the agreement, which was established in 2016 and amended in 2018.
Under this global collaboration, Merck and Moderna will split costs and profits equally.
Personalized cancer vaccines are intended to prime the immune system so that a patient’s immune system can generate a tailored antitumor response to his or her tumor mutation signature in order to treat cancer.
The goal is to tailor treatments to specific tumor mutations so that the body’s immune system can attack cancer cells more effectively.
The research begins with tissue samples taken from the patient. Researchers examine both normal and tumor cells in the samples to better understand a patient’s specific mutations and then create a personalized vaccine that can be manufactured and administered in a matter of weeks.
The Keynote-942 trial will follow patients for a year after melanoma tumor removal surgery. The primary endpoint is disease-free survival; researchers are also interested in overall survival and distant metastasis-free survival.
The companies are hoping for better results than with Keytruda alone.
mRNA-4157/V940 is intended to stimulate an immune response by generating T-cell responses based on a patient’s tumor’s mutational signature.
It is currently being assessed in combination with Merck’s anti-PD-1 therapy, Keytruda, as an adjuvant treatment for high-risk melanoma patients in Phase II clinical trial being conducted by Moderna.
Last month, Merck received approval from Japan’s Ministry of Health, Labor, and Welfare (MHLW) for Keytruda to treat various types of cancers.
Still, on the pharma research front, Eli Lilly and Company and Nimbus Therapeutics have formed a research collaboration for the development and commercialization of select small-molecule drugs for treating metabolic diseases in a deal worth up to US$496 million in payments, milestones, royalties, and funding.
The targeted therapies will activate a specific isoform of activated protein kinase (AMPK) to treat disorders of dysregulated metabolism, a common symptom of metabolic diseases.
Under the collaboration, Nimbus will be responsible for research activities, and Lilly will be responsible for development and commercialization activities worldwide.
Financial consideration for Nimbus includes a series of payments, funding, and milestones spread through research, development, and commercialization, potentially reaching up to US$496 million in total.
Nimbus is eligible to receive tiered royalties on global net sales ranging from mid-single- to low double-digits.
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