MARKET OPPORTUNITIES
ONCOLOGY PLATFORM
GENE MODIFIED CELL THERAPIES FOR CANCER / SOLID TUMORS
Currently into IND-enabling phase
Cancer cells can evolve to evade the immune system by releasing inhibitory signals or hiding from immune responses. Solid tumors have been particularly resistant to advanced immunotherapies.
RenovaroBio is creating therapeutic cancer vaccines with allogenic dendritic cells engineered to overcome tumor immune evasion and improve tumor eradication. Dendritic cells are key antigen-presenting cells that educate the immune system to target unwanted cells.
RENB-DC11: We have developed a modified version of dendritic cells, using a proprietary combination of genetic modifications, which has demonstrated significant effectiveness against aggressive human solid tumors in preclinical models.
LEVERAGING BANKED (OFF-THE-SHELF) ALLOGENIC CELL THERAPY
Advantages of utilising allogenic cells:
- Functional Activation of Immunity: Non-self allogenic cells enhance T-cell activation.
- Improved Safety: Allogenic cells are naturally rejected after activating cancer-killing cells and do not remain permanently in the body.
- Quicker Access to Therapy: A large bank of cryopreserved dendritic cells can reduce the time between diagnosis and treatment. Scaling production from a single donor source is also more cost-effective than autologous cell therapy.
- Versatile Platform: Our “ready to be loaded” approach with any tumor antigen allows for faster development of products for various cancer types.
RenovaroBio has partnered with Dr. Anahid Jewett from UCLA to investigate the effectiveness of this approach in pancreatic cancer, using an innovative mouse model that simulates the human immune system with implanted human cancer cells.
INFECTIOUS DISEASES PLATFORM
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.
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 to potentially 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-HV01: AUTOLOGOUS TRANSPLANT WITH GENETICALLY MODIFIED CELLS
FDA INTERACT Meeting Held February 2020: It was highlighted that gene-editing to knock down CCR5 expression in autologous human stem cells (HSC), when transplanted, can potentially cure HIV. Current methods, however, involve expensive and risky immune system ablation, and often, not enough gene-modified cells survive for durable HIV control.
We have developed a novel technology (ALDH gene modification) that may enable sufficient engraftment of CCR5-modified HSC, potentially eliminating the need for Antiretroviral Treatment (ART). Although our in vitro and in vivo results are promising, further development of RENB-HV01 is considered costly and long-term.
As a result, we decided to sub-license ALDH gene modification to Caring Cross, with a profit-sharing agreement. Caring Cross is working on a CAR-T approach that could be enhanced by our ALDH gene modification to improve the engraftment of their CAR-T cell therapy.
RENB-HV21: IMMUNOTHERAPY WITH ALLOGENEIC NK/GDT CELLS
Allogeneic Cell Therapy Platform
We are also exploring RENB-HV21, 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.
HBV:
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.