Pre-IND Meeting with the FDA for POLB 001
Poolbeg Pharma, a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the positive outcome of a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for POLB 001, the Company's lead asset, a potential preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome (CRS).
In a pre-IND meeting the FDA provides feedback on the clinical development strategy for drug candidates. This allows pharma companies to align their strategy with the FDA's requirements. The FDA feedback received by Poolbeg was broadly aligned with key aspects of the Company's envisioned development pathway for POLB 001. Poolbeg believes that there is an attractive route to market for POLB 001 and that this feedback re-affirms the appeal of the programme to potential partners.
The overall clinical development strategy was discussed and there was alignment on the proposed primary endpoint for a future Phase 3 clinical trial. Alignment with regulatory authorities on POLB 001's development pathway is an important milestone and provides potential partners with a higher degree of certainty of the route to market, thereby further de-risking the programme.
Bruno Speder, VP of Regulatory Affairs at Poolbeg Pharma, said:
We received constructive feedback from the FDA and achieved broad alignment on several important aspects of the development pathway for POLB 001. We believe that POLB 001 has the potential to address a critical unmet need in cancer immunotherapy-induced CRS, and this feedback provides greater clarity as we continue to advance the programme and supports our ongoing partnering discussions.
Nothing in this announcement is intended to imply FDA approval, nor does it represent FDA opinion on the efficacy, safety or approvability of the programme. The FDA meeting was intended only to obtain regulatory guidance on specific aspects of the proposed development and testing pathway.
