Pure Biologics has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase 0 clinical trial in Project PB003G for the PBA-0111 molecule.
- The study is expected to provide preliminary information on the effectiveness of PBA-0111, including activating immune cells and killing cancer cells. It will involve injecting microdoses of the PBA-0405 molecule directly into patients’ tumors.
- The study will be conducted in the US and will be multicenter and open-label. It is planned to recruit 12 patients with head and neck cancer, soft tissue sarcoma and triple negative breast cancer.
- The study is scheduled to be completed in 2024, and sub-results will be monitored as the study progresses.
- The Company’s strategic priority remains the signing of a partnership agreement – the Phase 0 results of the PB004 and PB003G projects could be an important determinant of their value growth. The Company continues discussions with pharmaceutical companies.
Dr Pieter Spee, Chief Scientific Officer Pure Biologics:
The FDA approval of the Phase 0 trial for the PB003G project is the result of the work of the Company’s dedicated research team. We are excited about the prospect of the upcoming results, which are expected to provide the first evidence of the efficacy of the PBA-0111 molecule. This will allow us to obtain the expected signals of efficacy in humans approximately two years earlier than the classical clinical plan.
Dr. Filip Jelen, co-founder, major shareholder and CEO of Pure Biologics:
Today we are reaping the rewards of years of hard work by the Pure Biologics team. As expected, just a few months after receiving FDA approval for the PB004 Phase 0 trial, we have received the green light from the FDA to initiate a similar trial for PB003G. Our development plan is highly cost-optimized and we hope to generate efficacy signals for both molecules in a parallel Phase 0 study. Such a scenario would certainly determine the value growth of our flagship projects. We are continuing our discussions with pharmaceutical companies in this regard.
Project PB003G is developing a dual-action therapeutic antibody that simultaneously eliminates immunosuppressive regulatory T (Treg) cells in the tumor microenvironment and stimulates cytotoxic NK and T cells to directly target tumor cells. The results of the PB003G project show, in our opinion, clear advantages over drug candidates with promising results in the early stages of clinical development. PB003G is an attractive drug concept with a very strong competitive advantage for commercialization in the cancer therapy market, with potential in the treatment of solid tumors.
The PBA-0111 molecule was tested for its safety profile, both in vivo and ex vivo, and showed no signs of molecular target [GARP] or immune system-dependent toxicity. The signs of toxicity observed in the mouse study were not confirmed in rats.