FDA Lifts Clinical Hold on Advaxis Drug, Shares Jump in Morning Trading


Shares of Advaxis are skyrocketing this morning after the company announced the U.S. Food and Drug Administration (FDA) lifted the clinical hold on its Investigational New Drug Application for a Phase I/II cancer study.

In March the FDA halted the trial that combines axalimogene filolisbac (AXAL) in with AstraZeneca’s Imfinzi (durvalumab) following the death of a patient. The patient died as a result of respiratory failure nine months after being dosed with the combination treatment. To lift the hold, the FDA and Advaxis agreed to new guidelines for the study that will assist with the early detection and treatment of “such rare events.”

 Princeton, N.J.-based Advaxis will now move forward with its study. The combination treatment is being studied in advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

Kenneth Berlin, president and chief executive officer of Advaxis, said that he was pleased the company was able to resolve the issue with the FDA. Investors were also pleased. Following the announcement, shares of Advaxis shot up more than 16 percent to $1.43 as of 10:15 a.m. Berlin said the company will implement the new FDA guidelines across its portfolio as needed in order to ensure patient safety.

“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,” Berlin, who was tapped to helm the company in April, said in a statement.

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.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer. The investigational drug has also received a Special Protocol Assessment for the Phase III AIM2CERV trial in HRLACC patients. The immunotherapy has also orphan drug designation in three clinical indications, Advaxis said.

AstraZeneca’s Imfinzi isn’t the only PD-1 inhibitor that Advaxis is pairing axalimogene filolisbac with. As BioSpace reported earlier this year, Advaxis 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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