Helocyte Announces $3.22 Million Grant from the National Cancer Institute for Triplex Phase 2 Clinical Trial Program

Multicenter randomized placebo-controlled trials will evaluate the ability of the cytomegalovirus (“CMV”) vaccine to enhance protective virus-specific immunity in stem cell donors to reduce the risk of CMV events in high-risk transplant recipients

Encouraging pilot study results demonstrate the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic hematopoietic cell transplant recipients at high risk for CMV reactivation

Helocyte., a subsidiary company of Fortress Biotech, is developing Triplex for the treatment of CMV

Triplex is currently the subject of multiple ongoing clinical trials, including: a Phase 1/2 trial for CMV control in pediatric recipients of HCT (see NCT03354728); a Phase 2 trial for reduction in viral load of Human Immunodeficiency Virus (“HIV”) in adults co-infected with HIV and CMV (see NCT05099965); and a Phase 1 trial of Triplex in combination with a bi-specific CMV/CD19 Chimeric Antigen Receptor T Cell for the treatment of Non-Hodgkin Lymphoma (see NCT05432635); Other planned studies of Triplex include: a multicenter Phase 2 trial for CMV control in recipients of liver transplant (U01AI163090, NCT# pending) and a Phase 2 trial for CMV control in recipients of kidney transplant

MIAMI, June 15, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), today announced that the National Cancer Institute (“NCI”) has awarded a $3.22 million grant to City of Hope for clinical studies of Triplex, a cytomegalovirus (“CMV”) vaccine being developed by Helocyte and City of Hope. This competitive award will fund two planned multicenter, placebo-controlled, randomized Phase 2 studies to evaluate the potential safety and immunological response of Triplex and its ability to enhance CMV-specific T cell immunity in stem cell donors to reduce the risk of CMV events in recipients of allogeneic hematopoietic cell transplant (“HCT”). Triplex was initially developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.

“Triplex has shown potential to enhance the transfer of CMV immunity from HCT donors to high-risk transplant recipients and reduce the use of antiviral prophylaxis that can impair and delay CMV immune reconstitution,” said Don J. Diamond, Ph.D., Professor, Hematology & Hematopoietic Cell Transplantation, City of Hope in Los Angeles, California and the grants’ principal investigator. Diamond and his team developed Triplex and he serves as a consultant to Helocyte. “We look forward to further evaluating this novel strategy that may provide a more effective approach to managing CMV events in those undergoing HCT.”