PDS Biotechnology Corporation Unveils Updated Positive Data from Versamune Hpv Abstracts
PDSB
Published on 06/02/2025 at 16:51
PDS Biotechnology Corporation announced publication of three Versamune HPV abstracts now available on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. A p16-positive test result suggests that the patient's cancer may be due to any of the over 100 types of HPV. PDS Biotechnology's trial differs from the other ongoing Phase 3 clinical trials addressing 1L r/m HNSCC based on its specific HPV16-positive HNSCC target population and its therapeutic approach.
To accurately identify and appropriately treat patients with HPV16-positive HNS CC, the U.S. Food and Drug Administration (FDA) recommended that a companion diagnostic be developed and included in the ongoing VERSATILE-003 Phase 3 trial. The mOS results are highly encouraging in patients with advanced HPV Type 16-positive HNSCC. As stated in a 2023 Journal of Clinical Oncology article authored by the FDA, OS is considered the gold standard for oncology approvals.
The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. 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 initiate the planned clinical trials for Versamune HPV, PDS01ADC 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 Versamune HPV, P DS01ADC and otherVersamune based product candidates 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 ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding 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 ongoing clinical trial; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical results and interpretation of preclinical results.