A quarter of a billion dollars! Merck Partners with Moderna to Advance mRNA cancer Vaccine plus K drug for melanoma

On October 12, Merck and Moderna jointly announced that Merck has chosen to co-develop and commercialize a personalized cancer vaccine (PCV) mRNA-4157/ V940 with Moderna under an existing collaboration and licensing agreement between the two companies.The vaccine is being used in combination with Merck's PD-1 antibody Keytruda (pembrolizumab) as an adjunct therapy in phase 2 trials for patients with high-risk melanoma.Under the agreement, Merck will pay Modena $250 million.Cancer vaccine research has been ongoing for almost two decades, with 170 cancer vaccine clinical research and development programs registered with ClinicalTrials.gov as of the end of April 2022.So far, the FDA has approved only one therapeutic cancer vaccine, Sipuleucel-T.

Personalized vaccines are one of the emerging trends in cancer vaccines.Traditional TAA (tumor-associated antigen, expressed in both normal and cancer cells, with higher expression in cancer cells) vaccines have drawbacks.The tumor antigen selected for the vaccine was not sufficiently robust in terms of immunogenicity or specificity.The Personalized cancer vaccine (de novo antigen vaccine) is based on neoantigen TAS (abnormal antigen produced by tumor cell mutation, expressed only in tumor cells and recognized by immune cells), which is the main development trend of cancer vaccine.

mRNA-4157/ V940 is a personalized cancer vaccine under development by Moderna that stimulates a T cell antitumor response based on a patient's tumor mutations.Keytruda, a humanized monoclonal antibody developed by Merck, blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes to destroy cancer cells.

Keytruda is currently approved by the FDA for the treatment of a variety of cancers, including melanoma, lung cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, renal cell carcinoma, endometrial cancer, bladder cancer, urothelial cancer, esophageal cancer, and gastric cancer..Keytruda has become the most approved anti-PD-1 MAB..Keytruda generated $17.2 billion in revenue in 2021 and is poised to overtake AbbVie's Humira as the world's best-selling prescription drug outside of COVID-19 vaccines, with sales continuing to grow this year.However, its patent expires in 2028 and continued expansion of its range of applications will help to strengthen its market position and sustain sales.This cancer vaccine in combination with Keytruda is currently being evaluated in the Phase 2 KEYNOTE-942 clinical trial in high-risk melanoma patients.The trial is scheduled to enroll 157 patients with high-risk melanomas.After complete tumor resection, patients were randomly assigned to receive either a combination of mRNA-4157/ V940 (9 doses every 3 weeks) and Keytruda (200 mg every 3 weeks) or Keytruda alone.

The trial lasted for 1 year or until the patient developed a recurrence of the disease or an unacceptable toxic effect.The primary endpoint of the trial was recurrence-free survival, with secondary endpoints including distant metastatic-free survival and overall survival.Enrollment has been completed in this Phase 2 trial and preliminary data are expected in the fourth quarter of 2022.