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US FDA grants orphan status to OncoSec's cancer drug

The U.S. Food and Drug Administration granted an orphan drug designation to OncoSec Medical Inc.'s pIL-12, known as tavokinogene telsaplasmid, for the treatment of unresectable metastatic melanoma.

Tavokinogene telsaplasmid is the active biologic agent in ImmunoPulse IL-12, the company's lead product candidate.

OncoSec said the designation will provide the company with eligibility for certain development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.

The company is starting a phase 2 trial of the product in combination with Keytruda in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.