OncoSec Medical Incorporated, a company developing DNA-based intratumoral cancer immunotherapies, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for pIL-12, otherwise known as tavokinogene telsaplasmid, for the treatment of unresectable metastatic melanoma. Tavokinogene telsaplasmid is the active biologic agent in OncoSec's lead product candidate, ImmunoPulse IL-12. The Orphan Drug status will provide OncoSec 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.
"This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization," said Punit Dhillon, chief executive officer and president of OncoSec. "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."
OncoSec is initiating the registration-directed PISCES trial, to evaluate the safety and efficacy of ImmunoPulse IL-12 and the approved anti-PD-1 agent, pembrolizumab, in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the US at any given time. For a drug to qualify for orphan drug designation both the drug and the disease must meet certain criteria specified in Section 525 of the Federal Food, Drug, and Cosmetic Act (21 USC 360aa). The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
PISCES will be a phase II multicenter study of ImmunoPulse IL-12 in combination with KEYTRUDA in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed on an approved anti-PD-1 therapy. The primary endpoint for this registration-directed trial is best overall response rate.
Us fda grants, orphan drug designation, treatment of unresectable, metastatic melanoma
