Message from Renovaro Bioscience, Inc.’s CEO, The Hon. Mark Dybul, MD - Seite 3

Advancing a Cancer Vaccine Toward Studies in Humans

Renovaro Biosciences has expanded the pre-clinical validation of the effectiveness of the cancer vaccine RENB-DC11. Dr. Jewett dubbed the results “the holy grail of cancer research” based on the highly reproducible results obtained in 4 experiments of pancreatic cancer in humanized mice conducted by UCLA, including:

- Rapid and significant tumor regression: an 80-90% decrease in tumor size;
- Effective tumor infiltration: significant infiltration of the tumor sack by effector immune cells, indicating ongoing killing of cancer cells;
- Immune Cell activation predicted by the anticipated mechanism of action: significant increases in the blood of effector immune cells and key markers of cancer-killing immune activation, and;
- Aggressive cancer progression inhibition: no metastases.

Recently, a leading contract research organization conducted an additional animal study that was designed to examine the effects of RENB-DC11 in a more advanced stage of pancreatic cancer. In the treated group, there were no metastases, and there was a significant reduction in tumor size – down to an undetectable level. Compared with previous studies, half the dose and a non-matched pancreas tumor line lysate, rather than matching it to the specific cancer tissue biopsy, were used.

In addition, Dr. Jewett conducted a preliminary study in liver cancer with promising results, showing a reduction in cancer progression, including metastases, and apparently improved survival in mice treated with the vaccine compared to the untreated group of animals.

While both studies are small and will be repeated, the results are encouraging and consistent with the strong response observed in all previous studies.

In addition, we have made substantial progress toward manufacturing clinical-grade material under Good Manufacturing Processes (GMP), enabling both safety and toxicity studies required for the filing of an Investigational New Drug (IND) application to initiate clinical trials.

Finally, we have finalized the design of the clinical protocol and have identified the principal investigator from the Department of Oncology at UCLA to conduct the first-in-human studies, which is projected to be at the end of 2024. Because our Senior Vice President for Clinical Operations has 32 years of experience at Pfizer, including creating and leading teams that managed human trials of cancer cell and gene therapies, we will retain complete control of the study with sub-contractors who have already been identified rather than outsourcing to a Clinical Research Organization. This should help ensure the combined Phase 1 and 2 trial’s quality and speed and reduce the estimated cost by 50%.