$11.3 Million Grant Funds CMV / HIV CAR T Cell Therapy Study for Adults with HIV
An innovator of novel immunotherapies has partnered with one of the largest cancer research in evaluating a CAR T therapy for HIV in an early-stage clinical trial so that one day, more people with Human Immunodeficiency Virus might achieve long-term remission.
Helocyte, Inc. today announced that it executed an exclusive option agreement with the City of Hope for patent rights to use Triplex, a cytomegalovirus (CMV) vaccine, in combination with cytomegalovirus-specific, Anti-Human Immunodeficiency Virus ("HIV") Chimeric Antigen Receptor ("CAR") (collectively, CMV/HIV-CAR) T Cells for the treatment of adults living with HIV.
Additionally, the California Institute for Regenerative Medicine recently awarded a $11.3 million grant to the City of Hope to fund a Phase 1 clinical trial that is expected to enroll up to 12 healthy individuals living with HIV-1 on stable anti-retroviral therapy ("ART") who have maintained viral suppression for at least 48 weeks.
The study will include three dose-escalating cohorts, along with an expansion cohort. Other cohorts will include further vaccination of subjects with Triplex to drive the continued proliferation of the CAR.
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.
Triplex was initially developed by the City of Hope and exclusively licensed to Helocyte in 2015.
"City of Hope made a major advancement when our transplant team helped a patient achieve remission for both HIV and leukemia," commented John A. Zaia, M.D., the Aaron D. Miller and Edith Miller Chair for Gene Therapy at City of Hope, in a press release on October 16, 2023.
The clinical study will build upon preclinical data published in Molecular Therapy - Methods & Clinical Development in April 2022, demonstrating the potential efficacy of combining a CMV vaccine and CMV/HIV CAR T cell therapy to eradicate HIV.
The study illustrated the potential long-term durability of the combination therapy, which induced therapeutic immune cells to take hold in bone marrow.
This approach aims to target and eradicate latent viral T cell reservoirs in immune cells to achieve complete HIV clearance.
To date, the engineering of T cells to express HIV-specific CAR T cells has failed to demonstrate meaningful clinical benefits. This is believed to be partly due to the effectiveness of highly active ART, which reduces HIV viral load to a level that prevents the activation of CAR T cells.
The use of Triplex is believed to stimulate CMV/HIV-CAR T cells to proliferate within patients' bodies.
In the preclinical study, CAR T cells were engineered to target and kill cells tagged with a particular protein called gp120, expressed in all HIV viruses, frequently with mutations that cause the virus to evade natural immunity without affecting healthy cells.
Lindsay A. Rosenwald, M.D., Fortress' Chairman and Chief Executive Officer and Chairman of Helocyte, Inc., added, "We look forward to building upon the data that continue to be generated relating to the use of Triplex in the treatment of HIV, including an ongoing Phase 2 clinical trial evaluating the safety and efficacy of Triplex in eliciting a CMV-specific immune response and reducing CMV replication in adults co-infected with HIV and CMV."
Helocyte, Inc., a subsidiary company of Fortress Biotech, Inc. For additional information regarding the grant, please see https://www.cirm.ca.gov/our-progress/awards/evaluation-safety-and-feasib....
As of October 16, 2023, there are no approved HIV prevention vaccines in the U.S.