After a rough year in which trials of its lead treatment were put on an FDA hold, small cap biotech Advaxis is bouncing back with a recent deal with Amgen ($AMGN) and today, some good news coming out of its pipeline about that once-halted med.
The Princeton, NJ-based company posted a small but, for the biotech, significant update from a portion of its Phase II late-stage HPV-associated oropharyngeal cancer (HPVOPC) trial.
The biotech said it met its “stage 1 primary objective” and will now move on into the second stage of the clinical study. The study is assessing its lead immunotherapy candidate, axalimogene filolisbac (aka AXAL).
The biotech said in a statement that it chalked up this success after looking at both IFN-γ and TNFα expressing T cells in the peripheral blood, and found that systemic HPV-reactive T-cell responses were increased in enough patients treated with AXAL to meet the stage 1 immune response target.
“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 2,” said the study’s lead investigator, Dr. Andrew Sikora of the Bobby R. Alford 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 next stage of the trial will enroll up to 13 patients with late-stage HPVOPC and will be run out of the Icahn School of Medicine at Mount Sinai, with a second site expected to be set up at Baylor College of Medicine.
This test is being partly funded by a three-year, $1.1 million grant from the FDA’s rare disease office.
This follows on from a deal with Amgen, signed earlier this month, worth potentially up to $540 million for its preclinical cancer immunotherapy candidate ADXS-NEO, which is intended to activate an individual patient’s immune system to respond to unique mutations, or neoepitopes.
Advaxis has drawn fairly strong interest from Big Pharma, having teamed up with Merck ($MRK) and its PD-1 drug Keytruda in a 2014 no-money-down collaboration. That followed a separate pact with AstraZeneca ($AZN) on the PD-L1 checkpoint inhibitor MEDI4736 and preceded another tie-up with Incyte ($INCY).
But last year, the FDA placed a clinical hold on AXAL in a separate study in cervical cancer after the death of a patient, and also slammed the brakes on its HPVOPC study.
The hold was cleared two months later, lifting its shares after initially plummeting on the FDA hold news.
The biotech saw its shares up by more than 1.7% premarket trading this morning, with a market cap of $470 million.
- check out the release