A little more than a month after Amgen quietly walked away from its $65 million upfront to partner with Advaxis $ADXS on axalimogene filolisbac, the biotech is reporting that the FDA has slapped the program with a partial hold ordering a stop to new enrollment in the Phase III. And this isn’t the first time.
According to the company’s release, regulators triggered the hold on their study for cervical cancer due to “requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters.” No new safety issues were identified, according to the biotech.
Now a penny stock biotech, Advaxis shares closed at just 31 cents today, down 10%. And the shares dropped 15% more after the news hit.
Advaxis is advancing therapies that use live attenuated Listeria monocytogenes which are engineered to secrete antigen/adjuvant fusion proteins. And they’re not simple to develop. The therapy uses bacteria to kick up an immune response by triggering a T cell attack on cancer cells.
“FDA’s review of the AXAL Investigational New Drug (IND) application was prompted by our proposal to modify the AIM2CERV trial’s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy,” said Kenneth Berlin, Advaxis’ CEO. “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. We have already begun efforts to address the Agency’s requests for information and are working to respond as promptly as we can.”
That event follows an earlier clinical hold on their lead program in combination with AstraZeneca’s PD-L1 checkpoint Imfinzi following a patient death, though the hold was later lifted. After a months-long holdup in H1 2018, researchers came up with new guidelines aimed at preventing any future instances of acute respiratory failure that killed the patient.
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