Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, on Thursday, announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA) for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.
The EMA granted PRIME scheme designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, reads a press release. The first detailed results of the trial will be presented at the American Association for Cancer Research (AACR) in Orlando from April 14-19.
“Prime scheme designation for mRNA-4157/V940 in combination with KEYTRUDA highlights the potential promise of individualised cancer treatments in a population with limited alternatives,” said Stephen Hoge, MD, Moderna’s President. “There is a high unmet need for therapies in melanoma, as it can be a life-threatening condition where available therapies may not be sufficiently effective in a significant proportion of patients.”
“This milestone underscores the potential for personalised approaches to help improve outcomes for people living with certain types of melanoma,” said Dr Eric H Rubin, senior vice president, global clinical development of Merck Research Laboratories. “We look forward to working with the EMA, in collaboration with Moderna, to advance our clinical development program for mRNA-4157/V940 in combination with KEYTRUDA.”
PRIME is a regulatory mechanism run by the EMA that provides support for the development of medicines that target an unmet medical need. Through PRIME, the EMA offers early and proactive support to help optimize the generation of robust data on a medicine’s benefits and risks and speed up the development and evaluation of medicines applications, to help patients benefit as early as possible from therapies that may significantly improve their quality of life.
As previously announced, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for mRNA-4157/V940 in combination with KEYTRUDA for the adjuvant treatment of patients with stage III/IV high-risk melanoma following complete resection. The companies continue to discuss the results of the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial with regulatory authorities and plan to initiate a Phase 3 study in 2023 and rapidly expand to additional tumour types, including non-small cell lung cancer.
What is mRNA-4157/V940
mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalised cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient’s tumour. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.
Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumour mutation signature. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour. KEYTRUDA is an immunotherapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Based on early clinical studies, combining mRNA-4157/V940 with KEYTRUDA may potentially provide an additive benefit and enhance T cell-mediated destruction of tumour cells.