Merck and Moderna collaborate to advance novel mRNA-based personalised cancer vaccines with Keytruda

Collaboration combines Merck’s leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and rapid cycle time, small-batch GMP manufacturing capabilities.

Moderna and Merck will develop personalised cancer vaccines that utilise Moderna’s mRNA vaccine technology to encode a patient’s specific neoantigens, unique mutations present in that specific patient’s tumour. When injected into a patient, the vaccine will be designed to elicit a specific immune response that will recognise 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 uniquely allow the company to supply vaccines tailored to individual patients within weeks.

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 personalised cancer vaccines in combination with Merck’s Keytruda (pembrolizumab). Moderna will also utilise the upfront payment to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston for the purpose of personalised 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 personalised cancer vaccines. Moderna will have the right to elect to co-promote the personalised cancer vaccines in the US. The agreement entails exclusivity around combinations with Keytruda. Moderna and Merck will each have the ability to combine mRNA-based personalised cancer vaccines with other (non-PD-1) agents.

“Combining immunotherapy with vaccine technology may be a new path toward improving outcomes for patients,” said Dr Roger Perlmutter, president, Merck Research Laboratories. “While the area of personalised 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 personalised cancer vaccines may have the potential to transform the treatment of cancer.”

“Our team has made significant progress since beginning our work in personalised cancer vaccines just last year. 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 individualised vaccines,” said Stéphane Bancel, CEO of Moderna. “We value our continued collaboration with Merck, and we look forward to working together to harness the potential of personalised cancer vaccines and immuno-oncology to bring a new treatment paradigm to patients.”