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PDS Biotech Completes First Stage of Enrolment in Checkpoint Inhibitor Refractory Arm of Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer
NetScientific plc
(“NetScientific” or the “Company”)
PDS Biotech Completes First Stage of Enrolment in Checkpoint Inhibitor Refractory Arm of Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer
VERSATILE-002 Phase 2 study investigates PDS0101 in combination with Merck’s KEYTRUDA® (pembrolizumab) in both checkpoint inhibitor refractory and checkpoint inhibitor naïve patients
NetScientific Plc (AIM: NSCI), investment and commercialisation group with an international portfolio of innovative life science, sustainability and technology companies, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has announced the completion of enrolment in the first stage of the checkpoint inhibitor refractory group of its VERSATILE-002 Phase 2 study for the potential treatment of recurrent and/or metastatic human papillomavirus (HPV16)-positive head and neck cancer. 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine.
VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab (KEYTRUDA®) in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations 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 has failed treatments including checkpoint inhibitor therapy (CPI refractory).
Dr Ilian Iliev, CEO of NetScientific, commented:
“We are delighted with PDS Biotech’s continued progress in its clinical trials, including the Phase 2 trial for combined therapy with Merck’s Keytruda® drug as detailed in their announcement. Congratulations to Frank and his team with their company’s continued advancements.”
Dr Lauren V. Wood, Chief Medical Officer of PDS Biotech, said:
“We are very pleased to have completed enrolment among checkpoint inhibitor refractory patients in this first stage for this group in our VERSATILE-002 Phase 2 study. This important milestone follows continued positive progress with the Phase 2 study, including data presented at ASCO 2022 and updated at our recent Head and Neck Cancer KOL Roundtable demonstrating the potential of PDS0101 in combination with pembrolizumab as a treatment for recurrent or metastatic HPV16-positive head and neck cancer.
“Currently, there are no approved therapies for CPI refractory head and neck cancer, with patients typically surviving less than a year. Our intent with VERSATILE-002 is to investigate the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”
A full version of PDS Biotech’s announcement can be accessed here.
For more information, please contact:
NetScientific
Ilian Iliev, CEO
Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj
+44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus
+44 (0) 203 008 6867
Email: nsci@belvederepr.com
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.