On May 3, 2018, Merck and Moderna Therapeutics, a biotechnology company focused on messenger RNA (mRNA) drug discovery and drug development, announced an expansion of their 2016 partnership to develop and commercialize novel personalized messenger mRNA cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671, Moderna’s mRNA v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) cancer vaccine.
Under the expanded agreement, Merck will be responsible for clinical development of mRNA-5671 and associated costs while Moderna will be responsible for clinical supply and associated costs. The two companies will jointly advance the cancer vaccine candidate in human studies and plan to conduct combination studies with additional immuno-oncology therapies. Following the completion of human proof-of-concept (hPOC) studies, Merck may opt-in on further development and commercialization of the cancer vaccine candidate upon payment of an undisclosed fee to Moderna. Following opt-in, the parties will equally share the global net profits and costs associated with the cancer vaccine candidate. The parties may also initiate and collaborate on other shared-antigen mRNA cancer vaccines programs. Moderna’s KRAS mRNA program uses tumor sequencing to identify suitable patients with specific mutations in KRAS in order to personalize the therapy.
KRAS is one of the most frequently mutated oncogenes in human cancer, occurring in approximately 90% of pancreatic cancers and 30% of non-small cell lung cancer (NSCLC), where they are associated with worse outcomes, according to Merck. Presentation of epitopes containing KRAS mutations to the immune system may cause an anti-tumor response. mRNA-5671, which Moderna began developing in 2017, encodes for the four most commonly found KRAS mutations and is designed to target most of the KRAS mutations that occur in NSCLC, colorectal cancer, and pancreatic cancer.
“While KRAS has long been a challenging target, we believe our mRNA platform offers a novel approach designed to generate and specifically present KRAS mutations to the immune system, potentially allowing the patient’s own immune system to attack and eradicate cancers that harbor these mutations,” said Stephane Bancel, CEO at Moderna Therapeutics, in the press release.
“Augmentation of immune responses offers great promise in cancer therapy, as our work with the PD-1-specific antibody Keytruda [pembrolizumab] has shown,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in a company press release. “We now look forward to expanding our exploration of mRNA cancer vaccines, working in concert with our colleagues at Moderna.”
According to Merck, this is the fourth collaboration between the two companies. The oncology partnership builds upon an initial June 2016 agreement to jointly develop personalized mRNA cancer vaccines. Under the 2016 personal cancer vaccine agreement, Merck made an upfront cash payment to Moderna of $200 million to discover and develop individually tailored cancer vaccines for patients across a range of cancers through POC.