PDS Phase 2 Clinical Trial Update
6th December 2021
PDS Biotech Provides Recruitment update for National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination
London, UK – 06 December 2021 – NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has announced the reopening 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.
The suspension of recruitment was administrative in nature and was unrelated to any specific safety or efficacy concerns associated with the triple combination being studied. As a result, during the recruitment suspension, patients already enrolled in the study continued to receive scheduled treatment. The timing of clinical results from this trial is not expected to be affected by the pause in recruitment of new patients.
The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal, and vulvar cancers in patients who are naïve to checkpoint inhibitors and have not responded to at least one standard of care therapy. Secondly in third line treatment of the above recurrent or metastatic HPV-positive cancers in patients who have not responded to at least two standard of care therapies including checkpoint inhibitor treatment.
Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer commented: “We are pleased that the NCI, part of the National Institutes of Health, quickly obtained IRB approval to resume recruitment in this important trial. We believe the interim data demonstrated that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-positive cancers who have limited treatment options. Our approach of treating multiple types of cancer based on their molecular profiles rather than tissue location, may have the potential to provide safe Versamune®-based treatment options to an expanded population of patients suffering from multiple types of cancer and at different stages of disease.”
Ilian Iliev, CEO of NetScientific, commented: “As anticipated in our announcement dated 21 October 2021, this temporary suspension in the recruitment for patients for one of the PDS Biotech Phase 2 clinical trials has now been restarted. The suspension was administrative in nature, unrelated to any specific safety or efficacy concerns, and has not affected the timing of expected clinical results from this trial. Alongside this NCI trial, PDS is continuing to make progress in the other Phase 2 trials and other projects underway. We look forward to clinical data and the next milestones, and remain supportive of PDS’ management.”
Full details of the announcement from PDS can be viewed here.
For more information, please contact:
| NetScientific | Via Walbrook PR |
| Ilian Iliev, CEO | |
| WH Ireland (NOMAD, Financial Adviser and Broker) | |
| Chris Fielding / Darshan Patel | +44 (0)20 7220 1666 |
| Walbrook PR | |
| Nick Rome/ Paul McManus/
Nicholas Johnson |
07748 325 236, 07980 541 893
or 07884 664 686 |