Merck & Co – known as MSD outside the US and Canada – has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV), mRNA-4157/V940, with Moderna in accordance with the terms of its existing collaboration and licence agreement.
Under the agreement, originally established in 2016 and amended in 2018, Moderna will receive an upfront payment of $250m from Merck, with the two companies sharing the costs and any profits equally under this worldwide collaboration.
PCVs are designed to prime the immune system so that a patient can generate a tailored antitumour response to their tumour mutation signature to treat their cancer.
mRNA-4157/V940 is currently being evaluated in combination with Keytruda, Merck’s anti-PD-1 therapy, in a phase 2 clinical trial being conducted by Moderna for the adjuvant treatment of patients with high-risk melanoma. Keytruda was selected as the comparator in the trial because it is considered a standard-of-care for high-risk melanoma patients, the companies outlined.
In the trial, following complete surgical resection, patients were randomised to receive mRNA-4157/V940 (nine doses every three weeks) and Keytruda (200mg every three weeks) versus Keytruda alone for approximately one year until disease recurrence or unacceptable toxicity.
The primary endpoint of the trial is recurrence-free survival, with secondary endpoints including distant metastasis-free survival and overall survival. The trial is fully enrolled and primary data is expected in the fourth quarter of 2022.
“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 Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
He added: “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.”
Also commenting on the partnership, Stephen Hoge, president of Moderna, said: “We have been collaborating with Merck on PCVs since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalised cancer treatment used in combination with Keytruda.
“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.”