공시 • Oct 29
PDS Biotechnology Corporation to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer
PDS Biotechnology Corporation announced that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration ("FDA") to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival (PFS) as an earlier primary endpoint in addition to median overall survival (mOS). If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company's trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused. The final survival results and durable clinical responses from the company's VERSATILE-002 trial are very exciting. About the VERSATILE-002 Trial: VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company's ability to protect its intellectual property rights; the Company's anticipated capital requirements, including the Company's anticipated cash runway and the Company's current expectations regarding its plans for future equity financings; the Company's dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company's operations or require the Company to relinquish rights to the Company's technologies or product candidates; the Company's limited operating history in the Company's current line of business, which makes it difficult to evaluate the Company's prospects, the Company's business plan or the likelihood of the Company's successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune HPV), PDS01ADC, PDS0103 (Versamune MUC1) and other Versamune based product candidates; the future success of such trials; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune HPV), PDS1ADC, PDS0101 and other Versamune MUC1 and the Company's interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company's product candidates; the success, timing and cost of the Company's or its partners' ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company's currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company's Company's interpretation of the Company's results and findings of such programs or collaborations and whether such results are necessary to support the future success of The Company's product candidates; the results, timing and cost of the company's or its partners' ongoingclinical trials and anticipated clinical trials for The Company's current product candidates, includes statements regarding response rates, the timeline of enrollment and completion of the trial (including the Company's ability of its disclosed clinical trials, which assume no material changes to the Company' currently projected expenses), futilityalyses, presentations at conferences and data reports in an abstract, and receipt the receipt of interim or preliminary results, which are not necessarily indicative of interim or preliminary results of the final results of the final results of The final results of the Company's final results of the Company's interim or preliminary results of the Company's results of the Company's results and data), which are not necessarily predictive results of the Company's interpretation of the company's interpretation of the Company's interpretation.