Advaxis gets fast-track status for bone cancer drug

US regulators designate cancer immunotherapy group's ADXS-HER2 for fast-tracking

Advaxis’s core discovery – LM Technology – alters a live strain of listeria bacteria to fight bone cancer

Cancer immunotherapy group (NASDAQ:ADXS) Advaxis Inc has won fast-track status for a new bone cancer drug.

Advaxis said the US Food & Drug Administration (FDA) had granted the designation for its ADXS-HER2 treatment for osteosarcoma.

Fast-track status was conceived in 1997 to speed up development of therapies for serious or life-threatening conditions for which there are no effective treatments.

The company’s products such as ADXS-HER2 are designed to harness the body’s ability to recognize and attack bacterial infections.

Advaxis’s core discovery – LM Technology – alters a live strain of listeria mono-cytogene bacteria to generate cancer-fighting T-cells.

Chief executive Daniel O’Connor said: “There are limited therapeutic treatment options available for this patient population, with no new treatments approved in over 20 years.

“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.”

Shares in Advaxis rose 6.45% to US$8.58 in morning New York trading. 

Quick facts: Advaxis

Price: 0.616 USD

Market: NASDAQ
Market Cap: $37.11 m

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