FDA puts clinical hold on Advaxis' cervical cancer vaccine

Advaxis CEO Daniel O'Connor

On Sept. 18, Advaxis ($ADXS) reported "encouraging" data from a Phase II trial of its cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. Now, the biotech is reporting an FDA clinical hold on the candidate--a full 5 days after the FDA placed the hold. Advaxis shares fell 25% to $7.63 in after-hours trading.

The hold affects four studies involving ADXS-HPV. According to a statement, the hold was issued in response to a safety report submitted to the FDA, which included "a single event of one patient with end-stage cervical cancer." The patient died.

"The company believes that axalimogene filolisbac played no role in the patient's death," Advaxis said in the statement. "Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program."

The patient had last received a dose of ADXS-HPV in early 2013, Advaxis said in the statement. She was hospitalized in late July this year for cervical cancer symptoms. The patient's blood cultures tested positive for a "highly attenuated strain" of Listeria monocytogenes, which is used in the vaccine to elicit an immune response against cancer, and which, according to Advaxis, is incapable of causing infection.

The patient received antibiotics, but was readmitted two weeks later and died. The investigator ruled cancer progression as the cause of death, a conclusion the company agrees with.

When Advaxis reported Phase II results for ADXS-HPV, CEO Daniel O'Connor said they were "some of the most encouraging Phase II data to date in metastatic cervical cancer." The biotech has teamed up with Incyte ($INCY) and AstraZeneca ($AZN) to test ADXS-HPV with the former's epacadostat and the latter's MEDI4736 in separate trials.

- here's the release
- and here's the FierceBiotech story