FDA Halts Advaxis Study Following Patient Death

Shares of Advaxis, Inc. are down more than 21 percent in premarket trading this morning after the company announced late Monday that the U.S. Food and Drug Administration halted a Phase I/II trial that uses an AstraZeneca Pharmaceuticals LPdrug following the death of a patient.

The FDA placed a clinical hold on the combination study of axalimogene filolisbac and AstraZeneca’s Imfinzi (durvalumab). The combination therapy was being tested in the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The regulatory agency halted the trial on March 9 after the death from respiratory failure was reported at the end of February. The patient’s death followed the sixth combination cycle in the trial, the company said.

Advaxis’ axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based investigational immunotherapy. The drug uses live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. It is being combined with AstraZeneca’s approved PD-1 inhibitor Imfinzi. The AstraZeneca drug has been approved by the FDA for non-small cell lung cancer patients who cannot have their tumors surgically removed, as well as some bladder cancers.

Anthony Lombardo, the interim chief executive officer at Advaxis, said the company cares deeply for the patients involved in its trials and is concerned for their safety as it works to develop new treatment options for advanced cancers. To reassure investors and the industry He added that the company believes in the potential of its Lm Technology to develop those treatment options.

"We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers," Lombardo said in a statement.

Case in point, in February Advaxis is seeking regulatory approval in Europe for axalimogene filolisbac as a second-line treatment of recurrent or metastatic carcinoma of the cervix.  This marked the first marketing application for its Lm Technology.  

The FDA halted enrollment and further dosing in the trial. Advaxis and its partner are working with the FDA to resolve the clinical hold. Advaxis noted that enrollment and dosing in all other company clinical programs are unaffected at this time.

AstraZeneca’s Imfinzi isn’t the only PD-1 inhibitor that Advaxis is pairing axalimogene filolisbac with. The company has also combined its lead product with Merck’s Keytruda for the treatment of prostate cancer and Bristol-Myers Squibb’s Opdivo for recurrent or metastatic squamous or non-squamous cell carcinoma of the cervix.

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