OncoSec Medical Inc.'s pIL-12 drug, also known as tavokinogene telsaplasmid, has been given an Orphan Drug Designation by the U.S. Food and Drug Administration.
The drug is used for treating patients with unresectable metastatic melanoma.
The company noted that tavokinogene telsaplasmid is the active biologic agent in ImmunoPulse IL-12, OncoSec’s lead product candidate. According to OncoSec, the FDA-granted designation will provide various benefits for the company, including development incentives, tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.
"This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization," OncoSec CEO and President Punit Dhillon said in a statement. "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 FDA grants Orphan Drug Designation status to products that treat rare diseases. The designation provides incentives for companies to continue work on the product. According to the FDA, rare diseases are those that affect fewer than 200,000 people in the United States.
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