Fortress Biotech and its subsidiary Helocyte have announced the dosing of the first subject in a multi-centre Phase II trial of the cytomegalovirus (CMV) vaccine, Triplex, for individuals who are undergoing haematopoietic stem cell transplantation (HSCT).
This trial focuses on administering the vaccine to human leukocyte antigen (HLA) matched related stem cell donors, to minimise CMV events in subjects undergoing HSCT.
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Funded by the National Cancer Institute (NCI) grant, the trial is set to demonstrate the vaccine’s safety and effectiveness.
Triplex is expected to trigger a CMV-specific immune response in the donor, which is then transferred to the transplant recipient.
The initial Phase II trial builds on the findings from the Phase I pilot study that explored Triplex’s immunological response and safety.
It is being carried out across three US transplant centres, including the Brigham & Women’s Hospital and Dana-Farber Cancer Institute in Boston, Northside Medical Center in suburban Atlanta, and City of Hope in Duarte, California.
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By GlobalDataIn addition, a subsequent NCI-funded trial will assess the same vaccine concept in higher-risk transplant recipients who are only partially HLA-matched to their donors. This follows a preliminary study in this transplant population.
Fortress Biotech chairman and CEO and Helocyte executive chairman Lindsay Rosenwald said: “This new vaccination paradigm carries the advantage of potentially conveying earlier and more robust CMV immunity to a stem cell transplant recipient, versus vaccinating an HSCT recipient after engraftment has occurred around four weeks following transplant.
“We are very pleased that this trial is underway and believe that this novel treatment approach could play a significant role in the prevention and treatment of CMV in the future. Triplex is the subject of multiple ongoing, planned clinical trials in the transplant setting and for HIV-1.”
Developed originally by the US cancer research and treatment organisation City of Hope, and exclusively licensed to Helocyte, Triplex is a universal recombinant Modified Vaccinia Ankara viral vector vaccine.
