PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer
6th October 2021
London, UK – 05 October 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 completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.
VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.
Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech “Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial.
“Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”
Ilian Iliev, CEO of NetScientific, commented: “We are delighted with the progress PDS is continuing to make with this Phase 2 clinical trial in collaboration with Merck & Co. This follows the positive preliminary results from the NCI-led Phase 2 trials announced in June this year.”
NetScientific’s interest in PDS amounts to c. 4.72 per cent.
The full text of the announcement from PDS Biotechnology is available online here: https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/113-2021-news/564-iotechnrollsirsttageofheckpointnhibitora20211004