Cytomegalovirus, oncology immunotherapies

Helocyte, Inc. is dedicated to developing innovative immunotherapies aimed at preventing and treating cancer and infectious diseases, particularly cytomegalovirus (CMV). Their flagship product, Triplex, is a multi-antigen vaccine designed to elicit a virus-specific T-cell response in patients undergoing allogeneic hematopoietic stem cell transplants (HSCT) and solid organ transplants (SOT). Triplex is unique in its clinical development as it utilizes a recombinant viral vector that expresses three immuno-dominant CMV proteins, specifically UL83 (pp65), UL123 (IE1), and UL122 (IE2). The vaccine is based on the Modified Vaccinia Ankara (MVA) vector, which has a strong safety profile, having been administered to over 120,000 patients, and has demonstrated significant immunogenicity.

The efficacy and safety of Triplex have been evaluated in multiple clinical trials, including a Phase 1b study that showed robust T-cell responses and a Phase 2 trial that confirmed a 50% reduction in CMV events among HSCT recipients who received the vaccine compared to those who received a placebo. The Phase 2 trial, conducted at prominent cancer centers, met its primary endpoint of reducing CMV events through Day 100 post-transplant, with no significant adverse effects reported. Ongoing and future studies aim to further explore the potential of Triplex, including strategies for early vaccination of donors to enhance CMV immunity in transplant recipients, positioning it as a promising alternative to standard prophylactic antiviral treatments.

United States

Helocyte, Inc. (“Helocyte”), a company founded by Fortress Biotech, Inc., is focused on the development and commercialization of novel immunotherapies for the prevention and treatment of cancer and infectious disease (in particular, cytomegalovirus or “CMV”)

Helocyte

Company Details