OncoSec Medical
(NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma.
The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence of short-duration electrical pulses to increase the cancer cell membrane’s permeability and more efficiently deliver the IL-12 gene therapy.
The federal watchdog granted OncoSec Fast Track designation for patients with metastic melanoma that have not responded to treatment with pembrolizumab or nivolumab.
“With the number of melanoma patients now being treated with either pembrolizumab or nivolumab in either the 1st- or 2nd-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,” president & CEO Punit Dhillon said in prepared remarks. “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.”
“This Fast Track designation by the FDA serves as an additional validation for OncoSec’s clinical development program,” chief clinical and regulatory officer Sharron Gargosky added. “As we launch our upcoming Phase IIb Pisces clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program.”
The company’s Phase IIb single-arm study plans to evaluate its ImmunoPulse IL-12 in combination with intravenous anti-PD-1 antibody in patients with stage III or IV metastatic melanoma.
The primary endpoint of the study will be overall response rate at 24 weeks, according to OncoSec, with secondary endpoints of best overall response rate, duration of response, median progression-free survival and overall survival. The clinical trial is slated to begin in the 2nd half of this year, the company reported.
ONCS shares were trading at $1.52 in morning activity today, up 9.1%.
