Merck & Co. has formed a strategic collaboration and license agreement with Moderna Therapeutics, a clinical-stage biopharmaceutical company, to develop and commercialize messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck's position in immuno-oncology with Moderna's mRNA vaccine technology and GMP manufacturing capabilities to advance individually tailored cancer vaccines across a spectrum of cancers.

Under the terms of the agreement, Merck will make an upfront cash payment to Moderna of $200 million, which Moderna will use to lead all research and development efforts through proof of concept. The development program will entail multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Merck's Keytruda (pembrolizumab). Moderna will also use the upfront payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalized cancer vaccine manufacturing.

Following human proof of concept studies, Merck has the right to elect to make an additional undisclosed payment to Moderna. If exercised, the two companies will then equally share cost and profits under a worldwide collaboration for the development of personalized cancer vaccines. Moderna will have the right to elect to co-promote the personalized cancer vaccines in the U.S. The agreement entails exclusivity around combinations with Keytruda. Moderna and Merck will each have the ability to combine mRNA-based personalized cancer vaccines with other (non-PD-1) agents. 

Moderna and Merck will develop personalized cancer vaccines that utilize Moderna's mRNA vaccine technology to encode a patient's specific neoantigens, unique mutations present in that specific patient's tumor. When injected into a patient, the vaccine will be designed to elicit a specific immune response that will recognize and destroy cancer cells. The companies believe that the mRNA-based personalized cancer vaccines' ability to specifically activate an individual patient's immune system has the potential to be synergistic with checkpoint inhibitor therapies, including Merck's anti-PD-1 therapy, Keytruda (pembrolizumab). In addition, Moderna has developed a rapid cycle time, small-batch manufacturing technique that will allow the company to supply vaccines tailored to individual patients within weeks.

Source: Merck & Co.