The FDA has put Advaxis’ phase 3 cancer vaccine clinical trial under a partial clinical hold, prohibiting it from enrolling patients. Advaxis suffered the latest in a string of setbacks after the FDA requested chemistry, manufacturing and controls (CMC) information.
In its release to disclose the partial clinical hold, Advaxis framed the FDA action as the result of a review that took place following a request to modify the analysis plan for the phase 3 cervical cancer trial. As Advaxis tells it, the review led the agency to request additional CMC information on the axalimogene filolisbac (AXAL) cancer vaccine being tested in the pivotal study.
“The primary focus of the items raised by the agency relates to providing additional clarifying details for CMC information previously provided in support of phase 3 development and which will help support a future biologics license application,” Advaxis CEO Kenneth Berlin said in a statement.
Advaxis can continue treating patients who are already in the trial but cannot recruit new subjects. The impact of that restriction on Advaxis’ prospects is tied to the duration of the partial hold. Advaxis said it is working to address the FDA’s requests for information and will respond as promptly as it can. The biotech expects to complete the 450-patient study in June 2022.
Prior setbacks mean Advaxis can ill afford delays. In recent years, two earlier, now-resolved clinical holds have slowed Advaxis’ progress and dragged down its stock. The company slipped deeper into penny stock territory in the back half of last year as a result of a share offering and loss of an Amgen pact.
The events have left Advaxis with a market cap of $22 million. As of the end of October, Advaxis had $45 million in cash. With its annual burn rate standing at $50 million following a cost-cutting drive, a cash crunch is looming on the horizon.
Advaxis’ ability to raise cash is hindered by its depressed stock price, making it vital that the biotech avoids setbacks and delivers impressive data in upcoming readouts. Data from an interim analysis of the AXAL phase 3 are due sometime in the future, and readouts from other studies are also on the roster for the first quarter and beyond.
Editor's note: This article has been updated to correct the forecast completion date of the phase 3 trial. It previously quoted the June 2020 estimated primary completion date listed on ClinicalTrials.gov.