Benzinga | Oct 21, 2021 12:11PM EDT

PDS Biotech Reports National Cancer Institute-Led Phase 2 Trial Of PDS0101-Based Combo Was Temporarily Suspended For Recruitment, 'no safety or efficacy concerns'

Temporary administrative suspension of recruitment -- no safety or efficacy concerns related specifically to the novel PDS0101-based combination study

FLORHAM PARK, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company's proprietary Versamune(r) T-cell activating technology, today announced the temporary suspension of recruitment in the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune(r)-HPV16) in combination with two investigational immune-modulating agents in advanced HPV cancers.

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 na?ve 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.