There are many cautionary tales on personalized cancer vaccines; Dendreon’s years-long manufacturing and efficacy struggles predated several, more recent failures. But that hasn’t dampened the enthusiasm of Merck ($MRK) and Moderna Therapeutics. The pair have done a deal to develop and market novel messenger RNA (mRNA)-based personalized cancer vaccines, which they expect to enter the clinic next year.
Merck will pay $200 million upfront to Moderna, which the company will use to lead all R&D efforts through proof of concept and to build out a suburban Boston manufacturing facility. The program will focus on several types of cancer and include combinations with Merck’s Keytruda (pembrolizumab).
“Combining immunotherapy with vaccine technology may be a new path toward improving outcomes for patients,” said President of Merck Research Laboratories Dr. Roger Perlmutter in a statement.
He added, “While the area of personalized cancer vaccine research has faced challenges in the past, there have been many recent advances, and we believe that working with Moderna to combine an immuno-oncology approach, using Keytruda, with mRNA-based personalized cancer vaccines may have the potential to transform the treatment of cancer.”
The pharma can elect, after the human proof of concept data, to make an additional undisclosed payment to Moderna. Upon that exercise, the pair will equally split costs and profits under a worldwide collaboration. Moderna can elect to co-promote the personalized cancer vaccines in the U.S. Each company will be able to combine the vaccines with other agents, in addition to Keytruda.
The mRNA vaccine technology encodes a patient’s specific neoantigens, unique mutations present in a specific tumor. When injected into the patient, the vaccine is intended to elicit a specific immune response to destroy those cancer cells. The vaccines are expected to be synergistic with checkpoint inhibitors, such as Merck’s anti-PD-1 Keytruda that is FDA-approved to treat unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1.
Moderna has also developed a rapid cycle time, small-batch manufacturing technique that it says will be able to supply vaccines to specific patients “within weeks.”
The pair already have an existing partnership to discover and develop mRNA-based infectious disease vaccines and passive immunity treatments. Moderna is in Phase I testing for its own internal pipeline of infectious disease vaccine candidates.
“Our team has made significant progress since beginning our work in personalized cancer vaccines just last year,” said Moderna CEO Stéphane Bancel. “Through this collaboration with Merck, we are now well-positioned to accelerate research and development with a goal of entering the clinic in 2017, as well as to apply our unique GMP manufacturing capabilities to support the rapid production of these highly individualized vaccines.”
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