The U.S. Food and Drug Administration (FDA) has granted orphan drug status to ImmunoPulse IL-12 (tavokinogene telsaplasmid), a treatment candidate being developed by OncoSec for unresectable metastatic melanoma.
OncoSec is a San Diego-based biotech company developing DNA-based intratumoral cancer immunotherapies with its investigational technology, ImmunoPulse, to enhance local delivery and uptake of DNA-based immune-targeting agents, such as IL-12.
ImmunoPulse IL-12, or pIL-12, OncoSec’s lead product candidate, is currently in Phase 1 and 2 clinical trials for metastatic melanoma and triple-negative breast cancer. The therapy has demonstrated a favorable safety profile and evidence of anti-tumor activity in treating several solid tumors, as well as a systemic immune response.
The current focus is on melanoma patients who are refractory or non-responsive to anti-PD-1/PD-L1 therapies.
“This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization,” Punit Dhillon, president and CEO of OncoSec, said in a 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.”
OncoSec is now launching the PISCES Phase 2/3 trial (NCT03132675) to evaluate the safety and efficacy of pIL-12 plus Keytruda (pembrolizumab), an approved anti-PD-1 agent. PISCES, which is not yet recruiting patients, will be a multicenter, 24-week study in patients diagnosed with progressive locally advanced or metastatic melanoma (stage 3 or 4). Its extension phase will last for up to two years or until disease progression, and includes a long-term safety follow-up.
OncoSec will soon start recruiting about 48 patients whose stage 3/4 metastatic melanoma is progressing or has progressed while on an approved anti-PD-1 therapy. The study’s primary endpoint will be best overall response rate. To learn more about eligibility and enrollment, email Sharron Gargosky, OncoSec’s chief clinical and regulatory officer, at email@example.com, or go to the trial’s website here.
The FDA grants orphan drug status only to products targeting rare diseases. The designation doesn’t change the regulatory requirements for obtaining marketing approval, but does provide the drug company with certain development incentives, including tax credits for clinical testing, user fee exemptions and seven years of market exclusivity.