Regulatory

After long delay following patient death, FDA lifts trial hold on Advaxis/AstraZeneca combo

The FDA has lifted its months-long clinical hold on an Advaxis combo therapy — first brought on by a patient death in its Phase I/II trial back in March — setting the New Jersey biotech up to move forward.

The news has sent Advaxis’ stock $ADXS soaring Friday morning, up 22% as of press time.

Kenneth Berlin

Its drug is called axalimogene filolisbac, an immunotherapy that attacks HPV-associated cancers by altering a live strain of bacteria to generate cancer-fighting T cells and neutralizing the tumor’s natural protections. The drug was being tested alongside AstraZeneca’s approved PD-L1 therapy Imfinzi before the patient death halted the trial.

Advaxis said the patient death occurred on February 27, post-dosing, and involved acute respiratory failure after nine months on the combo therapy. According to the company, it worked with the FDA to come up with new guidelines that will help it detect such events early on in patients and will use those guidelines in the combo study moving forward.

“We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis’ portfolio as needed, to ensure patient safety,” said Kenneth Berlin, president and CEO of Advaxis, in a statement. “We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1200 doses across multiple trials in HPV-associated cancers.”

Advaxis is also partnered with Bristol-Myers on an Opdivo combination program, which followed a separate alliance with Amgen.

 

 


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RAPS Convergence 2018

Director/Sr Director, Oncology/Immuno-Oncology
Aro Biotherapeutics Company Denver, CO
Director/Sr. Director Oncology
Aro BioTx Philadelphia, PA
Manufacturing Associate – Upstream
Molecular Templates Austin, TX
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Molecular Templates Austin, TX

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