Advaxis follows up Amgen deal with Phase IIa cancer trial success
pharmafile | August 12, 2016 | News story | Medical Communications, Research and Development | Advaxis, immunotherapy. cancer. Amgen
Advaxis, a US biotech in cancer immunotherapy development, has announced that its lead immunotherapy product axalimogene filolisbac (AXAL) has hit its stage one primary objective in its Phase II late-stage HPV-associated oropharyngeal cancer (HPVOPC) trial and will now proceed to stage two.
This follows a potential $540 million deal with Amgen signed earlier this month for its preclinical cancer immunotherapy candidate ADXS-NEO.
The study examined patients with stage I-IV HPVOPC who are to undergo ablative trans-oral robotic surgery (TORS) as a preoperative treatment, leveraging the five-to-six week period between diagnosis and TORS, making it possible to analyse and compare the tumour microenvironment as well as peripheral blood samples collected before and after AXAL treatments. The study’s main goal was to show that AXAL is highly immunogenic and worthy of further investigation if the overall rate of vaccine-induced T-cell responses was 75% or more.
“The assessment of the TNFα and IFN-γ response based on data from eight of the anticipated nine patients to be enrolled in stage 1 confirmed that the clinical study has already met the target for the overall rate of vaccine-induced T-cell response, paving the way for us to progress to stage two,” said the study’s lead investigator, Dr. Andrew Sikora of the Bobby R. Alford from the Department of Otolaryngology-Head and Neck Surgery at Baylor College of Medicine. “Together with our prior published data showing increased intratumoral T-cell infiltration in a significant number of AXAL-treated patients, these data provide the confidence needed to move forward with the definitive evaluation of its immunogenicity.”
The trial is being partly funded for $1.1 million over three years as part of a grant from the FDA’s rare disease office. The organisation had previously placed a clinical hold on AXAL last year following the death of a patient during a separate cervical cancer study, resulting in the company’s share price plummeting. The hold was lifted after two months.
Following this recent success, the company’s shares have risen 1.7% with a market cap of $470 million.
Matt Fellows
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