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

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OncoSec Medical Inc (NASDAQ:ONCS) shares advanced 5.04% on Monday to $1.46 but retreated 0.68% to $1.45 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 at 19.73 million shares outstanding.

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. The company’s 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, OncoSec Medical Inc 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.

In a press release this week, OncoSec Medical Inc announced that it received Fast Track designation from the U.S. Food and Drug Administration for its ImmunoPulse IL-12. This Fast Track designation is 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 receive this status benefit from more frequent communications and meetings with the FDA to review the drug’s development plan.

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.”

According to Sharron Gargosky, Ph.D., Chief Clinical and Regulatory Officer, the FDA Fast Track designation serves as an additional validation for the company’s clinical development program. Fast Track designated drugs may qualify for expedited FDA review and a rolling Biologics License Application if certain criteria are met.

“As we launch our upcoming Phase 2b PISCES clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program,” continued Gargosky.

The PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase 2b, Simon 2-stage, non-comparative, open-label, single-arm, multicenter study of ImmunoPulse IL-12 in combination with an intravenous anti-PD-1 antibody in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV.

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