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

Source: Healio, June 2017

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.”