- The Food and Drug Administration has placed a partial clinical hold on a Phase 3 study run by New Jersey biotech Advaxis, seeking additional clarifying details on chemistry, manufacturing and controls, or CMC.
- The trial is evaluating Advaxis' experimental drug axalimogene filolisbac in high-risk, locally advanced cervical cancer, which has poor five-year survival rates. The FDA's review arose from Advaxis' proposal to modify the trial's analysis plan to include a second formal interim analysis for both safety and efficacy.
- Advaxis said the agency hasn't called out any safety issues, and all enrolled patients will continue to receive treatment. The trial will be closed to new patients, however. Shares in Advaxis, which already trade below $1 apiece, fell further on Wednesday.
The notice is not the first clinical trial challenge for Advaxis and axalimogene filolisbac.
In March 2018, the FDA put the drug on a clinical hold after a patient died from respiratory failure in a Phase 1/2 study of the drug with AstraZeneca's Imfinzi (durvalumab) in advanced, recurrent or refractory human papillomavirus-associated cervical cancer and HPV-associated head and neck cancer, pulling the company's stock down by 15%. That clinical hold was lifted in July 2018, with the proviso that the company should incorporate new guidelines for early detection of respiratory failure.
In mid-2018, as the firm struggled to find a new CEO, Advaxis laid off around a quarter of its workforce and announced a plan to move its resources away from axalimogene filolisbac and towards ADXS-PSA, a clinical-stage drug targeting prostate-specific antigen, and its antigen-directed cancer programs ADXS-HOT and ADXS-NEO.
At the time, Advaxis also stated that it would be looking to wind down development of axalimogene filolisbac if it was unable to find a partner. It's not clear from Wednesday's release whether those plans still hold.
"We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can," said Advaxis CEO Kenneth Berlin.
"[Axalimogene filolisbac] has demonstrated a manageable safety profile in the over 400 patients we have dosed to date and we look forward to enrolling new patients in our AIM2CERV trial after FDA agrees that the information we submit is responsive to its requests."