NetScientific PLC (AIM:NSCI) portfolio company PDS Biotechnology Corporation (NASDAQ:PDSB) has completed a Type B meeting with the US Food and Drug Administration (FDA) for a combination treatment of recurrent/metastatic HPV-positive, ICI refractory head and neck cancer.
PDS Biotech confirmed with the FDA the required contents of the study design for a potential registrational trial of the combination of the drugs PDS0101, PDS0301 and a commercial immune checkpoint inhibitor.
PDS0101 is PDS Biotech's Versamune-based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers, and PDS0301 is a novel, proprietary investigational tumour-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency and longevity of T cells in the tumour microenvironment.
That combination is patented by PDS Biotech and performed well in a National Cancer Institute-led clinical trial in advanced HPV-positive ICI refractory patients. The combination, administered with an investigational bi-functional ICI, resulted in a median overall survival of 21 months, far longer than the historical median survival of 3-4 months, the company said.
"Head and neck cancers are the most common of all HPV-positive cancers and the number of cases is growing rapidly, according to the National Cancer Institute, one of the National Institutes of Health,” NetScientific CEO Ilian Iliev said in a statement.
“There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.”
"We remain impressed by PDS Biotech's steady progress across its clinical portfolio, and commitment to addressing unmet needs in cancer with more effective immunotherapy,” he added.
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