OncoSec Medical Inc (NASDAQ:ONCS) was up 3.45% to US$1.44 in early deals as it was granted FDA fast track designation for it its ImmunoPulse IL-12 to treat metastatic melanoma.
The move further validates the group’s clinical development program as it’s about to start a Phase 2b clinical trial, it said.
“With the number of melanoma patients now being treated with either pembrolizumab or nivolumab in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy.
“Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies,” said OncoSec president and chief executive Punit Dhillon.
“With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti-PD-1 therapy, we are increasingly confident in ImmunoPulse IL-12 to potentially convert ‘cold’ tumors to ‘hot’ tumors to effectively and safely improve the response rates of these patients.”
The FDA set up the fast track program to expedite the review of new drugs intended to treat serious or life-threatening conditions, and address unmet medical needs.
Story by ProactiveInvestors