The PB003G project is developing a potential dual-action biologic drug that simultaneously eliminates immunosuppressive regulatory T (Treg) cells in the tumor microenvironment and stimulates cytotoxic NK and T cells to directly target tumor cells. This is an attractive drug concept with a very strong competitive advantage for commercialization in the cancer therapy market. The proposed therapeutic approach has distinct advantages over other assets in early clinical development, which, by virtue of their mechanism of action, are an important benchmark for Pure Biologics.
- The PBA-0091 molecule will be developed as a novel immuno-oncology therapy targeting the GARP protein and will find application in the treatment of cancers for which there is still an unmet medical need.
- The molecule is being developed in Pure Biologics’ unique Bifunctional Fusion Protein (BFP, bimodal fusion protein) format, which shows significantly higher efficiency in killing cancer cells than conventional antibodies by engaging a broader population of immune cells.
- With the lead candidate selected, we have begun preparations for CMC contracting (larger scale production of the molecule) and preclinical studies. We expect the first results of PBA-0091 anti-tumor efficacy studies in animal models to be available by the end of Q2 this year.
- We assume that in the further course of the PB003G project, it will be possible to start clinical phase 1 in late 2024 and the trial could include patients with solid tumors.
- We have secured a total of approximately PLN 48 million in co-financing for the preclinical and clinical development of PB003 from non-dilutive grant sources.
Dr. Pieter Spee, Board Member and Chief Scientific Officer of Pure Biologics explains:
This is a very important milestone for us. PBA-0091 is our first molecule developed in our unique proprietary Bifunctional Fusion Protein (BFP) format. The selected lead candidate PBA-0091 demonstrates selectivity and stability, and more importantly, a clear competitive advantage over current anti-GARP therapies in early clinical development in the context of inducing killing of both immunosuppressive regulatory T cells and tumor cells. The PB003G project is progressing as planned toward clinical development. The project team has undoubtedly developed a successful nomination for further development of a leading molecule with high selectivity, required stability and very promising efficacy. The development pathway through clinical Phase 0, focusing on demonstrating proof of therapeutic efficacy in the setting of a real cancer tumor in patients, preceding the classic Phase 1-3 clinical trials, fully fits into our “Smart Immuno-oncology” business strategy. This approach will allow us to generate meaningful data for PBA-0091 in patients, which in turn will form the basis for a significant increase in asset value with a view to future commercialization of Pure Biologics’ drug development projects.
Dr. Filip Deer, co-founder, major shareholder and CEO of Pure Biologics comments:
According to the announced schedule, we have nominated the first lead candidate in project PB003G. In parallel, we are working on the selection of the second announced lead molecule – in project PB004. Later this year, we aim to begin Phase 0 clinical trials in both projects, which will allow us to determine the preliminary therapeutic efficacy of the drug candidates we are developing in the human cancer tumor setting.
The first studies in animal models with the proprietary molecules, determination of pharmacokinetic and pharmacodynamic (PK/PD) properties, and initiation of preclinical safety studies are planned for Q2 2023. The development of a manufacturing process for the drug candidate (CMC stage) and submission of an eIND filing (exploratory IND, a form of application for clinical trial approval with the US FDA) and initiation of a Phase 0 clinical trial (the first studies in humans after local administration of the investigational molecule to the tumor) are scheduled for the second half of 2023. The phase 0 study is expected to be completed in Q2 2024.
In December 2022. Pure Biologics announced that it is accelerating development and focusing its activities on projects PB003 and PB004, for which it has secured grant funding from the National Center for Research and Development and the Medical Research Agency in the total amount of about PLN 100 million. The Company’s plans are oriented – thanks to the synchronous development of projects PB003 and PB004 – to accelerate the progress of work and optimize costs in the projects.
We plan to carry out both projects in a novel approach involving a Phase 0 clinical trial, which may allow us to obtain the first information on the effectiveness of compounds in humans even two years sooner than in the case of the classic approach, based on Phase I and II clinical trials. At the same time, the data will be obtained at a financial outlay significantly lower than that of the aforementioned classical approach. In December 2022. The company announced that it had entered into an agreement with the US company Presage Biosciences Inc. for the first human administration of PB003 and PB004 molecules in Phase 0. The study is scheduled to start in Q4 2023. We assume that the start of clinical Phase 1 may be possible by the end of 2024 and the trial could include patients with solid tumors.