FDA grants orphan drug designation to pIL-12 for unresectable melanoma

The FDA granted orphan drug designation to tavokinogene telsaplasmid for the treatment of unresectable metastatic melanoma, according to the agent’s manufacturer.

Tavokinogene telsaplasmid (pIL-12, OncoSec) is the active biologic agent in ImmunoPulse IL-12 (OncoSec), an intratumoral anticancer gene therapy that expresses interleukin-12.

“This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization,” Punit Dhillon, CEO and president of OncoSec, said in a company-issued press release. “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.”

Through a collaboration with Merck, OncoSec will conduct the registration-directed, multicenter, phase 2 PISCES trial.

Researchers will evaluate the safety and efficacy of ImmunoPulse IL-12 and pembrolizumab (Keytruda, Merck) in patients with stage III or stage IV metastatic melanoma who progressed on prior treatment with an anti-PD-1 therapy.

Best overall response will serve as the primary endpoint.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.