HIV Overview

Antiretroviral therapy (ART) has changed HIV-infection from a death sentence to a chronic disease. However, ART requires life-long therapy that is expensive and has the risk of significant side effects. In addition, drug resistance is growing, which requires new and often more costly products. From a patient-centered approach, life-long therapy can be challenging, and unfortunately, stigma and discrimination remain strong throughout the world. More than 40 percent (40%) of the 36.7 million people who need therapy do not have access to it. More than one million people die from HIV every year, and more than 1.8 million become newly infected. A cure and a preventive or therapeutic vaccine could transform the lives of millions of people.

RENB-HV-01: Autologous Transplant with Genetically Modified Cells

FDA INTERACT Meeting Held February 2020

It has been proven that gene-editing to knockdown the expression of CCR5 — a door HIV needs to enter and kill CD4+ T cells — in autologous human stem cells (HSC) combined with transplantation can lead to a cure of HIV. However, the approaches currently available require an expensive and risky ablation of the immune system. Even with that drastic intervention, an insufficient number of gene-modified cells survive to achieve durable control of HIV.

We have pioneered a novel enabling technology (ALDH gene modification) that we believe will allow sufficient engraftment of the CCR5 gene-modified HSC to eliminate the need for Antiretroviral Treatment (ART.)

Management conducted a successful FDA INTERACT Meeting in alignment with Renovaro’s experimental plan. Although in vitro and in vivo studies have demonstrated promising results, further development of RENB-HV-01 at this time was deemed costly and a long-term undertaking. While the Company plans to return to full development of the approach when resources are available, it had become less attractive and deprioritized for business reasons, while pipelines that could move more quickly have been prioritized (e.g., DC-11). Therefore, a business decision was made to sub-license the ALDH gene modification.

RENB-HV-01 was sub-licensed to Caring Cross with a profit share. Caring Cross is developing CAR-T approach that they believe when combined with Renovaro Biosciences ALDH gene modification, could enhance engraftment of their CAR-T cell therapy and enhance their likelihood of success.

RENB-HV-12: Preventive and Therapeutic Vaccines

Allogeneic Cell Therapy Platform

Boosting a person’s immune system through vaccination can lead to protection from HIV infection in people who are not living with HIV. In persons living with HIV who are controlling the spread of virus with antiretroviral (ARV) treatment, boosting the immune system in a different way than the virus already has through infection, could allow control of HIV after stopping ARVs.

Renovaro BioSciences’ technology uses the powerful induction of an immune response created by cells from another person potentially to induce such a response. Based on promising in vitro results, a study in non-human primates was begun by the renowned Fred Hutchinson Cancer Research Center, Seattle, Washington.

Preliminary results are expected by late 2023. If successful, human studies potentially could begin in late 2024.

RENB-HV-21: Immunotherapy with Allogeneic NK/GDT cells

Allogeneic Cell Therapy Platform

We are also exploring RENB-HV-21, an innovative treatment for HIV with allogenic Natural Killer (NK) and Gamma Delta T-Cells (GDT). It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could both be infected by, and be a key factor in controlling the virus. The initial scientific findings were presented during the ASCGT Conference 2021. Renovaro BioSciences has an exclusive license to use the underlying patent to develop RENB-HV-21 for potential treatment or cure of HIV. A successful investigator-initiated Pre-IND was completed in October 2021. However, due to a shift in priorities to the Oncology pipeline, Renovaro BioSciences does not plan to pursue the IND and potential clinical trial in the near to medium-term.