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Personalis, Moderna Collaborate on mRNA Cancer Vaccine Development

NEW YORK – Personalis on Friday said that it signed an agreement with Moderna to apply the Personalis NeXT platform to a clinical trial of an mRNA-based cancer vaccine.

mRNA-4157/V940 is an mRNA-based vaccine that can be designed to code for up to 34 neoantigens based on the mutational signature of the patient's tumor. In the Phase IIb KEYNOTE-942 trial, Moderna and Merck, who are developing the vaccine together, are studying mRNA-4157/V940 in 157 patients with stage III/IV melanoma. Patients were randomized to receive the vaccine in a total of nine doses and Keytruda (pembrolizumab) or Keytruda alone until disease recurrence or intolerable toxicity. In December, Merck and Moderna said the trial met its primary endpoint of improvement in recurrence-free survival for patients on the vaccine-Keytruda combination.

Now under the new agreement, the NeXT platform, which was used in the KEYNOTE-942 trial, will be used to sequence patient tumor DNA to identify genetic mutations most likely to generate a tailored antitumor immune response in upcoming clinical trials of the vaccine. 

This is the latest in a series of agreements Personalis has inked for use of its technology. In November, the company partnered with the University of California, San Francisco to apply its liquid biopsy assay, NeXT Personal, to discover circulating tumor DNA signals in a study of late-stage CRC patients receiving capecitabine with Keytruda and Genentech's Avastin (bevacizumab). Another agreement, signed in October, gives Duke University and Olink Proteomics access to Personalis' ImmunoID NeXT platform to study genomic, transcriptomic, and proteomic responses of gastroesophageal tumors following treatment with Keytruda.

Shares of Personalis were up nearly 30 percent to $3.91 in early Friday trading on the Nasdaq after finishing up about 20 percent on Thursday.