Moderna Therapeutics and Merck expanded their 2016 collaboration deal to develop and commercialize personalized messenger RNA (mRNA) cancer vaccines. The new deal will include mRNA cancer vaccines that share antigens, including mRNA-5671, Moderna’s mRNA KRAS cancer vaccine.
Moderna is something of a puzzle. The company is terrific at raising money—as of February, it had closed on its seventh private equity financing round worth $500 million, bringing it to a total $1.4 billion in cash, as well as access to up to around $250 million in grants from the Bill & Melinda Gates Foundation, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), and the Defense Advanced Research Projects Agency (DARPA). Overall, it has raised around $1.7 billion in private funds. It has a $7 billion valuation, an extremely high figure for a private company.
What the company doesn’t have is a commercial product. It does have 19 pipeline candidates.
The company’s technology is based on mRNA, whose job in the cells is to transport genetic information from DNA to the ribosome, providing the amino acid sequence of the eventual proteins the DNA is coded for. The company engineers mRNA to then deliver whatever protein codes they want the cells to produce, turning the cells into vaccine or drug-manufacturing plants.
As part of this expansion, the two companies will work together to advance mRNA-5671 into human studies. They also expect to conduct combination studies with more immuno-oncology therapies.
“Augmentation of immune responses offers great promise in cancer therapy, as our work with the PD-1-specific antibody Keytruda has shown,” said Roger Perlmutter, president, Merck Research Laboratories, in a statement. “We now look forward to expanding our exploration of mRNA cancer vaccines, working in concert with our colleagues at Moderna.”
KRAS is an oncogene and is one of the most likely to have mutations that stimulate cancer development. It appears in about 90 percent of pancreatic cancers and 30 percent of non-small cell lung cancer (NSCLC), where they generally indicate poor outcomes. It is the companies’ belief that if they present epitopes—pieces of tumor antigens that contain KRAS mutations—to the immune system, it may stimulate the immune system to attack those tumors. mRNA-5671 encodes for four of the most commonly observed KRAS mutations. It is designed to target KRAS mutations found in NSCLC, colorectal cancer and pancreatic cancer.
Under the expanded arrangement, Merck will handle clinical development of mRNA-5671 and the costs associated with it. Moderna will handle clinical supply and the costs associated with that. After human proof-of-concept studies, Merck has the option for further development and commercialization of mRNA-5671 upon payment of an undisclosed fee to Moderna.
If they do opt in, the companies will equally share global net profits and commercialization costs. Both companies can also initiate and collaborate on other shared antigen mRNA cancer vaccines programs. Merck, as part of the deal, will make a $125 million investment in Moderna, buying newly priced series H preferred equity.
“We are excited to build upon our productive relationship with Merck and to rapidly advance our novel mRNA-based KRAS cancer vaccine into the clinic,” said Stephane Bancel, Moderna’s chief executive officer, in a statement. “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.”
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