The two companies entered into a strategic collaboration for novel mRNA-based PCV with Keytruda in 2016 with Merck paying Moderna $200m to lead research and development efforts through proof of concept.
Now, Merck is exercising its option to develop a vaccine, currently in Phase 2 trials in patients with high-risk melanoma, with Moderna through to commercialization for an additional $250m. The two companies will share costs and any profits equally under this worldwide collaboration.
PCV potential
Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response to their tumor mutation signature to treat their cancer. mRNA-4157/V940 is designed to stimulate an immune response by generating T cell responses based on the mutational signature of a patient’s tumor.
mRNA-4157/V940 is currently being evaluated in combination with Keytruda, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase 2 clinical trial conducted by Moderna.
“This long-term collaboration combining Merck’s expertise in immuno-oncology with Moderna’s pioneering mRNA technology has yielded a novel tailored vaccine approach,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with our colleagues at Moderna to advance mRNA-4157/V940 in combination with Keytruda as it aligns with our strategy to impact early-stage disease.”
Cancer vaccines is one of Moderna's seven key focus areas. Through next-generation sequencing, it identifies mutations found on a patient’s cancer cells called neoepitopes, which can help the immune system distinguish cancer cells from normal cells. It can then a personalized vaccine which is loaded onto a single mRNA molecule. A rapid cycle time, small-batch manufacturing technique and digital infrastructure can be used to produce each individually manufactured personalized cancer vaccine to the patient rapidly.
“We have been collaborating with Merck on PCVs since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalized cancer treatment used in combination with Keytruda,” said Stephen Hoge, M.D., President of Moderna.
“With data expected this quarter on PCV, we continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer. Continuing our strategic alliance with Merck is an important milestone as we continue to grow our mRNA platform with promising clinical programs in multiple therapeutic areas.”