With $21 Million Funding Commitment, CMV Vaccine Candidate Launches Phase 2 Clinical Study

A vaccine candidate for control of the cytomegalovirus (“CMV”) in patients undergoing liver transplantation dosed its initial patient in a multi-center, placebo-controlled, randomized Phase 2 clinical study.

Initially developed by the City of Hope, Triplex was exclusively licensed to Helocyte.

Triplex is a universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins [UL83 (pp65), UL123 (IE1), UL122 (IE2)] linked to CMV complications in the post-transplant setting.

The trial is funded by a grant from the U.S.S NIH’s National Institute of Allergy and Infectious Diseases to the University of Washington Seattle. This grant has provided $9 million to date, with an estimated additional $12 million over the next four years in support of the Phase 2 clinical trial.

Ajit Limaye, M.D., Professor of Medicine and Director of the Solid Organ Transplant Infectious Disease Program at the University of Washington and Principal Investigator of the “CMV vaccine in Orthotopic Liver Transplant” trial, said in a press release on May 14, 2024, “There remains a significant unmet medical need to develop new therapies that can reduce the frequency and severity of CMV events in the organ transplant setting, where CMV continues to present life-threatening complications that directly impact patient outcomes and survival.”

According to the U.S. CDC, CMV is a common virus for people of all ages.

In the U.S., nearly one in three children is already infected with CMV by age five. About 1 out of 200 babies are born with congenital CMV.

And over half of adults have been infected with CMV by age 40.

Once CMV is in a person’s body, it stays there for life and can reactivate. According to the CDC, most people with CMV infection have no symptoms and aren’t aware that they have been infected.

Helocyte is a clinical-stage company developing novel immunotherapies to prevent and treat cancer and infectious diseases, including CMV and HIV.