Regenerative medicine for the durable remission of HIV: Translational medicine for IND-enabling preclinical and manufacturing studies

Globally, over 36 million people are living with HIV-1. The current standard of care, antiretroviral therapy (ART), requires lifelong adherence to remain effective. However, ART can lead to serious long-term side effects and carries a high lifetime cost. Alarmingly, only 65% of patients achieve full viral load control with ART. This underscores the urgent need for new therapies that offer more sustained and effective responses. MarPam is developing a regenerative medicine therapy as a one-time treatment for HIV. This therapy uses a patient’s own immune cells, engineered to target and destroy hidden reservoirs of virus-producing cells. The team is currently testing its innovative treatment in a non-human primate model of HIV. With RMM funding, the team is developing a production process for their novel CAR-T therapy using blood from HIV-infected study participants. Additionally, they will conduct FDA required, GLP-compliant preclinical studies with these engineered CART-T cells. If successful, the team will file an Investigational New Drug (IND) application with the FDA and move forward to human clinical trials.