Pure Biologics proudly announces that it has received approval from the United States Food and Drug Administration (#FDA) for an exploratory Investigational New Drug (eIND) for testing PBA-0111 in a Phase 0 clinical study in solid tumor #cancer patients. The Phase 0 study will be a multicenter, open-label #study conducted in the United States in up to 12 patients with head and neck #carcinoma, soft tissue #sarcoma and triple negative breast cancer. The Phase 0 study will focus on detection of early signs of pharmacodynamic activity of PBA-0111, after a single-dose injection directly in the #tumor, including #immune-cell activation and tumor cell killing, to confirm the PBA-0111 therapeutic mode of action in a real patient setting. Pure Biologics has partnered with Presage Biosciences, Inc. (Seattle, USA) to execute the studies. The Phase 0 study is expected to be completed in the end of 2024. Before then, the Company expects partial results as the study progresses. PBA-0111 is a fully human #antibody #drug candidate targeting GARP in the tumor micro-environment. PBA-0111 alleviates #immuno-suppression, a major obstacle in current immuno-therapy treatment, as well as directly initiates tumor killing by the immune system. The results of research under the PB003G project indicate, in the Company's 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 in the context of commercialization on the cancer therapy market, with potential in the treatment of solid tumors. Studies performed in tumor-bearing humanized mice suggest that PBA-0111 holds great promise for solid tumor #treatment. The Phase 0 clinical study aims at front-load the acquisition of data on effectiveness of PBA-0111 in a human patient setting to further guide clinical development towards market authorization. Dr. Pieter Spee, Chief Scientific Officer of Pure Biologics said: 'The approval of PBA-0111 is a testimony to the dedicated team of researchers involved in PBA-011 development. We are very excited about starting the PBA-0111 Phase 0 study, as it allows us to obtain first proof of the effectiveness of PBA-0111 in human cancer patients two years faster in the PBA-0111 development path than we would be able to obtain in Phase I and II clinical trials.' Dr. Filip Jelen, PhD, MBA, PhD, MBA, co-founder and President of the Management Board of Pure Biologics said: 'These are exciting times for Pure Biologics! After FDA eIND approval for PBA-0405, we have now received FDA eIND approval for PBA-0111 a few months later. The outcome of the planned Phase 0 clinical study will lead to a significant increase in the value of the project. The Company's goal is to conduct a partnering transaction for at least one of the Company’s drug candidates, PBA-0405 and PBA-0111, in the coming year.'
Marek Orłowski
3mo
Fantastic news 👍 I keep my fingers crossed for the future results 🤞
Anna Kostyn
3mo
Great news! Congratulations! We keep fingers crossed!
Peter Chudy
3mo
Congratulations to the Pure Biologics team on a job well done!
Nice. Great news!
Maciej Stopa
3mo
Great news.
Birgit Mund
3mo
Great news!
Biotech consultant I Freelance I Drug discovery and development I Immuno-oncology I Scientific Advisor
3moThis approval marks Pure Biologics' second FDA approval shortly after the approval of PBA-0405 for the Phase 0 clinical trials. Pure Biologics demonstrates delivering results thanks to the dedicated teams that generated the data and made this possible.