Shares in Advaxis have dropped more than 21% after the company announced that the FDA has 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 HPV-associated cervical cancer and HPV-associated head and neck cancer.
The FDA halted the trial 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 stated.
“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,” Anthony Lombardo, interim chief executive officer at Advaxis, commented in a statement.
Advaxis noted that enrollment and dosing in all other company clinical programs are unaffected at this time and that alongside their partner; they are working with the FDA to resolve the clinical hold.
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® (pembrolizumab) for the treatment of prostate cancer and Bristol-Myers Squibb’s Opdivo® (nivolumab) for recurrent or metastatic squamous or non-squamous cell carcinoma of the cervix.