Fortress Biotech Subsidiary Helocyte Announces Option Agreement with City of Hope for Exclusive Worldwide Rights to use a Novel Bispecific CMV/HIV CAR T Cell Therapy (optionally in combination with Triplex) for the Treatment of Adults Living with HIV-1

Recent $11.3 million grant from the California Institute for Regenerative Medicine (CIRM) intended to fund the Phase 1 clinical trial at City of Hope; the Investigational New Drug application for which has now been accepted by the Food and Drug Administration

In preclinical studies, administration of the dual-action CAR T cells followed by administration of a CMV vaccine successfully eradicated HIV, including from latent reservoirs

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, see NCT06075745); a Phase 2 trial for CMV control in recipients of kidney transplant; and a Phase 2 trial for CMV control in recipients of stem cell transplant in which the stem cell donor is vaccinated with Triplex (see NCT06059391)

MIAMI, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress Biotech, Inc. (“Fortress”) (Nasdaq: FBIO), today announced that it executed an exclusive option agreement with City of Hope for patent rights to use Triplex, a cytomegalovirus vaccine, in combination with cytomegalovirus (“CMV”)-specific, Anti-Human Immunodeficiency Virus (“HIV”) Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T Cells for the treatment of adults living with HIV. 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.

Additionally, the California Institute for Regenerative Medicine (“CIRM”) recently awarded a $11.3 million grant to City of Hope to fund a Phase 1 clinical trial. The Phase 1 trial 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 continued proliferation of the CAR. The trial will initially enroll at City of Hope and University of California at San Diego.