Advaxis Says FDA Grants Fast Track Designation For ADXS-HER 2

Advaxis, Inc. ADXS revealed the Food and Drug Administration has given a Fast Track Designation for its immunotherapy product candidate ADXS-HER2. According to the company, the drug candidate was for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.

Advaxis stated its investigational immunotherapies, including ADXS-HER2, were designed to capitalize on the body's ability to recognize and attack bacterial infections. The company's core technology – Lm Technology – alters a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T-cells directed against a cancer antigen and neutralizing factors, which defend the tumor microenvironment from immunologic attack, as well as, contribute to tumor growth.

The company's CEO, Daniel O'Connor, said "We are pleased that the FDA has granted this important designation for ADXS-HER2. Currently, there are limited therapeutic treatment options available for this patient population, with no new treatments approved in over 20 years."

He added "ADXS-HER2 received orphan drug designation in 2015 from the FDA and EMA for the treatment of osteosarcoma. We believe that with these FDA implemented incentive programs, like Fast Track designation, patients are truly the benefactors."

Following the news, the stock traded 5.4 percent higher in pre-market trading.