Our Technology for HIV

Gene-Modified Cell Therapies for HIV

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.

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

FDA INTERACT Meeting Held February 2020
Advanced Pre-Clinical Stage

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 approach that we believe will allow sufficient engraftment of the gene-modified HSC to eliminate the need for ART.

In vivo and in vitro data supporting the scientific foundation of the approach has been presented at the annual meeting of The American Society of Gene and Cell Therapy in May 2020.

In a transgenic mouse model, the technology increased engraftment in bone marrow by 163%. For context, a 10% increase is often thought to be successful.

Management considered the FDA INTERACT Meeting to be successful with alignment with Enochian’s experimental plan. Additional in vitro and in vivo experiments are underway. Pre-IND submission is possible by the end of 2021, potentially with human studies beginning in 2022.

Increased Engraftment of Gene Modified HSPCs Overexpressing ALDH1 In Vivo

Poster Presentation Link Here Slide Presentation Link Here

Gene Modified CD34+ Cells with Increased ALDH1 Expression Confers In Vitro Protection Against Cyclophosphamide

Poster Presentation Link Here Slide Presentation Link Here

ENOB-HV-11 and 12: Preventive and Therapeutic Vaccines

Allogeneic Cell Therapy Platform
Advanced Pre-Clinical Stage; Non-Human Primate Studies Begun

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.

Enochian Bio’s 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 the end of 2021 or early 2022. If successful, human studies potentially could begin in 2022.

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

Allogeneic Cell Therapy Platform
Pre-IND Scheduled
Advanced Pre-Clinical with Human Data through a Collaboration

On June 14, Enochian Bio announced that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential functional cure or treatment of HIV. Written comments are expected this Fall.

An Investigator-Initiated Pre-IND was completed. The request was based on the results of a 54-year old man living with HIV who had failed to suppress the virus with antiviral therapy. The patient subsequently achieved viral control for 255 days with an innovative treatment of Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person. During the entire period, no antiviral drugs were given. It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.

The findings were presented during the Conference of the American Society of Gene and Cell Therapy this past May. Presentations can be found here.

IND-enabling cell manufacture will begin in the near term with expectation of Investigator-Initiated IND being submitted in the Fall of 2022 and enrollment in a Phase I clinical trial enrollment commencing by the end of the year.

Enochian BioSciences holds the exclusive license for the proprietary technology.

This innovative cellular therapy could be an important approach to achieve a “functional cure” of HIV, potentially allowing persons with the virus to stop antiviral treatment for extended periods of time. The Pre-IND submission requested that the novel strategy be extended to persons with HIV who have achieved suppression of the virus with antiviral treatment.

ENOB-HV-31: In Vivo Gene Therapy

Hijack RNA Platform
Early Pre-Clinical

HIV is an RNA virus. Based on the Hijack RNA Platform, an approach to “seek and kill” HIV-infected cells has been developed. In vivo and in vitro studies should begin in the near term.