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High-dose axalimogene filolisbac immunotherapy will advance to expansion phase.
Advaxis Inc., a clinical-stage biotechnology company developing cancer immunotherapies, presented a poster featuring clinical development advances with its Lm Technology at the Society for Immunotherapy of Cancer 2015 Annual Meeting on November 4-8 in National Harbor, Maryland.
The purpose of the study was to evaluate whether axalimogene filolisbac could be dosed at higher levels than previous studies in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).
While previous clinical studies of axalimogene filolisbac were evaluated at 1 x 109 colony forming unit (CFU) data from this Phase I dose escalation study showed axalimogene filolisbac may be safely administered with prophylactic antibiotics up to 1 x 1010 CFU, a tenfold increase. Higher doses of axalimogene filolisbac have been shown in preclinical trials to correlate with increased antigen presentation and greater targeted antitumor activity.
Clinical data from the ongoing Phase I/II clinical trial reported the first evidence for the safety and tolerability of axalimogene filolisbac at higher doses in patients with PRmCC.
In the study, a total of 27 cycles of therapy were delivered at the 5 x 109 CFU dose level and to date, 5 cycles at the high dose of 1 x 1010 CFU, the lower dose will now constitute the randomized Phase II dose (RP2D). The adverse events observed at the high dose are consistent with previous experience.
The RP2D will now be explored further in an expansion cohort in subjects with PRmCC.