OncoSec Medical Inc (NASDAQ:ONCS) Gains FDA Fast Track Designation


OncoSec Medical Inc (NASDAQ:ONCS) shares rose 5.04% to $1.46 then dipped 0.68% in after-hours trading. Share prices have been trading in a 52-week range of $1.03 to $3.49. The company has a market cap of $28.20 million at 19.73 million shares outstanding.

In a press release yesterday, OncoSec Medical Inc shared that it received Fast Track designation from the U.S. Food and Drug Administration for its ImmunoPulse IL-12 product.

“With the number of melanoma patients now being treated with either pembrolizumab or nivolumab in either the first-  or second-line settings, there will be an increasing number of patients who will not respond to therapy. Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies,” said Punit Dhillon, OncoSec Medical Inc President and CEO. “With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti-PD-1 therapy, we are increasingly confident in ImmunoPulse® IL-12 to potentially convert ‘cold’ tumors to ‘hot’ tumors to effectively and safely improve the response rates of these patients.”

He added that this FDA Fast Track designation serves as an additional validation for the company’s clinical development program. This was granted by the agency to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and demonstrate the potential to address unmet medical needs.  Products under this designation benefit from more frequent communications and meetings with the FDA to review the drug’s development plan. These may also qualify for expedited FDA review, and a rolling Biologics License Application if certain criteria are met.

OncoSec Medical Inc is a biotechnology company that is focused on designing, developing and commercializing gene therapies, therapeutics and medical approaches to stimulate an anti-tumor immune response for the treatment of cancer. Its lead product candidate, ImmunoPulse IL-12, consists of a plasmid construct encoding the proinflammatory cytokine, IL-12, which is delivered into the tumor through in vivo electroporation.

As of July 31, 2016, the company was pursuing two Phase II trials: ImmunoPulse IL-12 monotherapy in patients with metastatic melanoma and ImmunoPulse IL-12 plus pembrolizumab in patients with advanced, metastatic melanoma. In addition, it is pursuing ImmunoPulse IL-12 monotherapy in patients with triple negative breast cancer. Its ImmunoPulse product candidates are based on its deoxyribonucleic acid (DNA)-based immunotherapy technology, which is designed to stimulate the human immune system, resulting in systemic anti-tumor immune responses.