Shares in Advaxis slipped as much as 24 percent after the company said that the FDA placed a clinical hold on a Phase I/II study investigating axalimogene filolisbac in combination with AstraZeneca's Imfinzi (durvalumab) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
According to Advaxis, the clinical hold comes after the submission of a safety report to the FDA regarding a patient death last month involving respiratory failure, which occurred following the sixth combination cycle in the trial. The company noted that it is working with AstraZeneca and the agency to review the event in detail and to resolve the clinical hold.
In 2014, AstraZeneca entered a collaboration to study its anti-PD-L1 immune checkpoint inhibitor Imfinzi, previously known as MEDI4736, in combination with Advaxis' cancer immunotherapy vaccine axalimogene filolisbac, previously dubbed ADXS-HPV.
For related analysis, read ViewPoints: Advaxis dissecting its latest clinical hold.
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