Utilizing allogenic cells had several advantages to our development strategy.

1. Functional activation of immunity: Non-self allogenic cells further T-Cells.

2. Possible enhanced safety: allogenic cells will be rejected naturally after they performed their role in activating cancer killing cells, and will not permanently reside in the body.

3. Faster access to therapy after diagnostic. Large cell bank of cryopreserved dendritic cells that are ready to be pulsed with patient tumor can decrease time between diagnostic and treatment. Moreover, our ability to scale up production using a single donor source of stem cells will provide a more cost effective solution than autologous cell therapy.

4. True platform of “ready to be loaded” with any tumor antigen allows for faster development of multiple products addressing multiple cancer types.

Renovaro BioSciences has initiated a collaboration with Dr. Anahid Jewett from UCLA to study further the in vitro and in vivo effectiveness of the approach in pancreatic cancer. Dr. Jewett created an innovative pancreatic cancer mouse model that mimics the human immune system in combination with implanted human cancer cells…

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.

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.) Although in vitro and in vivo studies have demonstrated promising results, further development of RENB-HV01 at this time was deemed costly and a long-term undertaking.

Therefore, a business decision was made to sub-license the ALDH gene modification. RENB-HV01 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.

RENB-HB01: HBV Gene Therapy

RENB-HB-01 is in early pre-clinical phase as we explore various approaches for gene therapy design elements. If those explorations are successful, it is possible we could begin the regulatory process at the earliest in the first half of 2024. However, our highest priority for investment is the oncology platform, beginning with pancreatic cancer.