- The FDA has lifted a clinical hold on the development of Advaxis' three immuno-oncology drugs. In October, a patient in one of Advaxis' clinical trials died, leading to the FDA's decision to put the trials on hold.
- Advaxis will now continue development of its therapies, which are being developed for treatment of head and neck cancer, cervical cancer, anal cancer, and prostate cancer.
- Axalimogene filolisbac is the company's lead candidate. Advaxis shares have flown 55% since Tuesday afternoon on the news.
In early October, a woman with cervical cancer died during a clinical trial involving Advaxis' axalimogene. The FDA was concerned the drug may have been involved, while Advaxis said that the patient died from natural progression of the disease. The hold stemmed from concerns the patient's death was caused by the bacteria, listeria, used to deliver the immunotherapy.
The FDA now has lifted the hold and development has been re-started. In addition to axamilogene, Advaxis is also developing ADXS-PSA for prostate cancer in combination with Merck's Keytruda. A third compound, ADXS-HER2, is under development for patients with HER2-mutated cancers.
As of this morning, Advaxis (52 week range: $4.71 to $30.13) is trading around $11 after rebounding from a major dip in October.