Merck & Co. and Moderna Therapeutics said today they will partner to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines through a collaboration that will generate at least $200 million upfront for Moderna.
The collaboration is designed to combine Merck’s immuno-oncology know-how with Moderna’s mRNA vaccine technology and GMP manufacturing capabilities. The companies agreed to use Moderna’s mRNA vaccine technology to develop individually tailored cancer vaccines that encode a patient’s specific neoantigens, eliciting an immune response intended to recognize and destroy cancer cells.
Merck and Moderna reason that the vaccines can work with checkpoint inhibitor therapies, including Merck’s marketed anti-PD-1 therapy Keytruda® (pembrolizumab). The partners also plan to use Moderna’s rapid-cycle-time, small-batch manufacturing technique, designed to enable the company to supply vaccines tailored to individual patients within weeks.
“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,” Moderna CEO Stéphane Bancel said in a statement. “Our team has made significant progress since beginning our work in personalized cancer vaccines just last year.”
The collaboration is not the first between Merck and Moderna. In January 2015, the companies launched an up-to-$100 million-plus partnership to develop antiviral vaccines and passive immunity therapies based on Moderna’s mRNA technology. The companies agreed to develop five new mRNA-based treatments and vaccines against four undisclosed viruses.
Last October, Moderna launched its fourth venture, Caperna, focused exclusively on advancing personalized cancer vaccines. Caperna is separate from the mRNA cancer vaccine development being pursued by Moderna’s initial oncology venture, Onkaido, which was established in 2014.
In this latest partnership, Merck agreed to pay Moderna $200 million cash upfront, which Moderna said it will use to lead all R&D efforts through human proof-of-concept studies. Moderna said it 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. The company is headquartered in Cambridge, MA.
Following the proof-of-concept studies, Merck has the option to make an additional undisclosed payment to Moderna. If Merck exercises that option, the companies will equally share cost and profits under a worldwide collaboration for the development of personalized cancer vaccines, with Moderna retaining the option to co-promote the personalized cancer vaccines in the U.S.
The development program will consist of multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Keytruda—for which the companies’ agreement offers exclusivity.
Moderna and Merck will also have the ability to combine mRNA-based personalized cancer vaccines with other (non-programmed death 1 [PD-1]) agents.
“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,” added Roger Perlmutter, M.D., Ph.D., president, Merck Research Laboratories.
Last year, Moderna completed the largest funding event among privately held early-stage drug and diagnostic developers last year, raising $450 million in a private investment round.