21 November

eIND submission for the PB004 project and further development of PB003G towards Phase 0

  • We have applied to the U.S. Food and Drug Administration (FDA) for approval to test molecule PBA-0405 (exploratory Investigational New Drug; eIND), the lead candidate in project PB004 in a Phase 0 clinical trial in patients with solid tumors.
  • At the same time, we have decided to continue studies in Project PB003G on candidate PBA-0111 aiming to join the planned Phase 0 study, which should take place after the planned completion of preclinical follow-up studies and regulatory approval.
  • The addition of PB003G to the PB004 study will not affect its schedule or the total cost of conducting the Phase 0 study, which will be the same regardless of the number of molecules tested.
  • The Phase 0 study for both molecules is expected to conclude in H1 2024. Prior to that, the Company expects partial results as the study progresses.
  • The PB004 project is progressing on schedule for submission of the eIND application and completion of the Phase 0 study in H1 2024. The addition of candidate PBA-0111 in the PB003G project is planned as previously anticipated.

Dr. Pieter Spee, Board Member and Chief Scientific Officer of Pure Biologics said:

The in vitro and in vivo results of candidates PBA-0405 and PBA-0111 in the PB004 and PB003G projects make us optimistic. The molecule development plan associated with Phase 0 is oriented toward accelerating the acquisition of first efficacy data in humans, while minimizing project risks in preclinical and clinical trials. We make decisions in this regard based on the results obtained from in vivo and in vitro studies, consulting with an international group of advisors with whom we collaborate in scientific and regulatory areas.

Dr. Filip Jeleń, co-founder and CEO of Pure Biologics said:

Since the results of the animal studies in projects PB004 and PB003G, we have been focusing on candidates PBA-0405 and PBA-0111, which have demonstrated efficacy in both in vitro and in vivo models. In a few months, we plan to confirm this efficacy in the first patient study as a result of the Phase 0 trial. This is a key short-term scientific milestone today, which could determine a significant increase in the value of the projects.

The Company’s goal is to conduct a partnering transaction against at least one of the PB003G and PB004 projects. Pure Biologics is in active discussions with medium and large pharmaceutical companies interested in potential deals.

The Phase 0 study will be a multicenter, open-label trial conducted in the United States involving up to 15 patients with solid tumors. The study is expected to identify early signs of pharmacodynamic activity of PB004 and potentially PB003G, including immune cell activation and tumor cell killing. The study will involve injecting microdoses of the Company’s drug candidates directly into patients’ tumors.

The Phase 0 study could yield the first information on the molecules’ efficacy in humans up to two years faster than 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 for the aforementioned classical approach.

The company has signed agreements with reputable companies specializing in conducting Phase 0 and related regulatory issues – Presage Biosciences Inc. and Intrinsik Corp.

Project PB004 is a potential biologic drug. It involves the development of a novel therapeutic molecule in the format of an afucosylated IgG1 class antibody to stimulate the immune response of NK cells against tumor cells bearing the tumor antigen ROR-1, leading to their direct killing by an antibody-dependent cellular cytotoxicity (ADCC) mechanism. The PB004 molecule is being developed for the treatment of solid tumors, including triple-negative breast cancer, as well as for the treatment of selected hematological malignancies, including chronic lymphocytic leukemia, among others.

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. According to the Company, the results of the PB003G project show clear advantages over drug candidates with promising results in early 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.

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