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

The initial Phase 2 clinical trial will build upon Phase 1 pilot trial data (NCT03560752) that evaluated the potential safety and immunological response of Triplex presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR and published in American Journal of Hematology. The study will be conducted across up to 3 nationally recognized transplant centers in the United States. A second trial, also funded by the award, will formally test the same concept, and will include highest-risk transplant recipients, who are only partially HLA-matched to their donors. Preliminary work for that transplant population was carried out under NCT04060277.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman and Chief Executive Officer, said, “We are very excited that Triplex, being progressed by Helocyte, is the subject of this NCI grant which will enable the further evaluation of the vaccine’s potential to control CMV in patients undergoing high-risk HCT. CMV is a common opportunistic infection in transplantation, directly impacting post-transplant outcomes and patient mortality. The trial will build upon the growing patient database of Triplex, which has already been dosed safely in over 150 patients and volunteers, and is the subject of multiple other ongoing and planned studies.”

Research reported in this publication was supported by the NCI of the National Institutes of Health under Award Number R01CA266783. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Helocyte will provide clinical materials to support the trial.

About Triplex
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. In previous Phase 1 and Phase 2 studies, Triplex was found to be safe, well-tolerated and highly immunogenic. 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/CD-19 Chimeric Antigen Receptor T Cell for the treatment of Non-Hodgkin Lymphoma (see NCT05432635). Triplex is also the subject of several planned studies, including: a Phase 2 evaluation for CMV control in recipients of liver transplant; and a Phase 2 trial for CMV control in recipients of kidney transplant.