OncoSec Medical (NSDQ:ONCS) said today that its DNA-based intratumoral cancer immunotherapy, pIL-12, won orphan drug designation from the FDA for the treatment of unresectable metastatic melanoma.
The drug, tavokinogene telsaplasmid, is the biologic agent delivered using OncoSec’s ImmunoPulse IL-12 electroporation device.
The company’s device delivers a sequence of short-duration electrical pulses to increase the cancer cell membrane’s permeability and more efficiently deliver cancer-killing drugs.
The orphan drug status provides OncoSec’s product with 7 years of market exclusivity and exempts the company from a prescription drug user fee.
“This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization,” president & CEO Punit Dhillon said in prepared remarks. “We are diligently working to address a significant unmet medical need in melanoma patients who are progressing or have progressed after treatment with anti-PD-1.”
The San Diego-based company also said it is launching a trial to evaluate the safety and efficacy of ImmunoPulse IL-12 and pembrolizumab in patients with metastatic melanoma who have experienced disease progression despite previous treatment with an anti-PD-1 therapy.
ONCS shares were up 2% in mid-morning activity, trading at $1.14 apiece.