On October 21, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the temporary suspension of recruitment in the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents in advanced HPV cancers (Press release, PDS Biotechnology, OCT 21, 2021, View Source [SID1234591693]).
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The issue is not specific to the PDS0101 trial and is unrelated to any safety or efficacy concerns with the triple combination. The NCI anticipates that the issue should be resolved timely, at which time the PDS0101 trial recruitment will resume. The timing of clinical data resulting from this trial is not expected to be affected by the recruitment suspension.
"We know from the interim data that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-associated cancers who have limited treatment options. While the trial is experiencing a slight administrative delay, we are pleased to report that the PDS0101 trial recruitment has progressed well and it is anticipated that it will resume recruitment shortly. We believe based on the previously reported results, that this treatment could significantly improve survival benefit for these patients, and we look forward to resumption of the trial in the near term," said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer.
The trial is evaluating the novel combination in both checkpoint inhibitor naïve and refractory patients with advanced HPV-associated cancers that have progressed or returned after treatment. The vast majority of these cancers are caused by HPV16.