FDA lifts clinical hold on Advaxis, sending shares skyrocketing.
The U.S. Food and Drug Administration has just lifted a clinical hold on drug developer Advaxis, potentially paving the way for one of its cancer drugs to move forward.
The hold had been placed after a person died on the company’s lead therapy, axalimogene, but the company claimed the person had died due to the progression of cervical cancer, and not because of the drug, according to a Reuters report. Despite that, the FDA placed a hold on all three therapies the company produced. Now, that has been lifted.
The news sent shares of Advaxis skyrocketing 38 percent. The shares had been down about 19 percent since the hold been announced. They reached $10.57, not quite beating their previous high of $11.45 per share.
As a result of this development, Advaxis said it could resume studies on the three therapies, which attempt to fight cancer by causing the body’s immune system to turn on the disease. In response to concerns raised by the FDA, the company will install some risk mitigation measures, such as revising the study design, ensuring better surveillance of patients, and implement patient inclusion criteria, according to the report.
Axalimogene filolisbac is being used in patients who have head, neck, cervical, and anal cancer. It is studying ADXS-PSA in combination with Merck drug Keytruda, as well as ADXS-HER2 in patients where mutation was the cause.
Advaxis is a New Jersey-based company that is focused on developing immunotherapies based on an engineered form of the bacteria Listeria monocytogenes. The company has 15 distinct constructs in various stages of development.
Their therapies aim to create an immune response to a secreted antigen, which is specifically found in cancer cells, causing the immune system to attempt to eliminate those cancer cells.