NetScientific PLC (AIM:NSCI) said its portfolio company, PDS Biotechnology Corp, has completed an end-of-phase two meeting with the US Food and Drug Administration (FDA) for the treatment of HPV16-positive HNSCC.
Earlier this year PDS was granted FDA fast-track designation for PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
It is for the treatment of unresectable, recurrent/metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC), NetScientific said in a statement.
Frank Bedu-Addo, PDS Biotech chief executive, commented: “The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule.
“This, along with the recent capital raise, allows us to efficiently advance our clinical programs.”
The FDA fast track programme is used to accelerate the review of a drug that could possibly treat serious or life-threatening conditions. FDA can also aid in the development of such drugs.
Treatments granted this status can have more frequent meetings and FDA interactions during the development and review process, with the goal of moving promising drugs more rapidly through the procedure.
Ilian Iliev, NetScientific chief executive, commented: "We are pleased with PDS' continued and systematic progress on its business objectives, despite unfavourable capital markets conditions.
“Building on momentum from the FDA fast track designation in June 2022, and the subsequent US$35mln venture debt facility in August 2022, PDS is now well positioned for further progress in its PDS101 clinical programme."