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Merck Exercises Option on Moderna Cancer Vaccine

NEW YORK – Moderna on Wednesday said Merck has exercised its option to jointly develop and commercialize Moderna's investigational personalized cancer vaccine, mRNA-4157/V940, in combination with Keytruda (pembrolizumab) as a melanoma treatment.

Under a 2016 collaboration between the two firms, Merck paid $200 million upfront to Moderna to develop mRNA-based personalized cancer vaccines that could be combined with its checkpoint inhibitor Keytruda. In the deal, which was amended in 2018, Merck had the option to jointly develop the mRNA-4157/V940 vaccine candidate and equally share costs and profits under a worldwide collaboration. Now that Merck has exercised this option, it will pay an additional $250 million to Moderna.

The mRNA vaccine is designed to target 20 tumor-associated antigens uniquely expressed by a patient's cancer cells. These neoantigens are identified by conducting next-generation sequencing on each patient's cancer cells and are transcribed and loaded onto the mRNA molecule, with the goal that when patients receive the vaccine, it will charge up their immune systems to recognize and attack cancer cells.

Moderna is currently evaluating mRNA-4157/V940 in combination with Keytruda versus Keytruda alone as an adjuvant treatment for high-risk melanoma patients in a Phase II trial. The company expects to report data from this trial in Q4.

"We have been collaborating with Merck on personalized cancer vaccines since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalized cancer treatment used in combination with Keytruda," Moderna President Stephen Hoge said in a statement. "With data expected this quarter on personalized cancer vaccines, 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."

Moderna had two other cancer vaccine programs in early development, a KRAS vaccine and a checkpoint vaccine. Similar to mRNA-4157/V940, Moderna's other cancer vaccines are also tailored to neoepitopes present on a patient's cancer cells, which are identified through NGS.