On November 09, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported it presented a poster featuring clinical development advances with its Lm Technology at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2015 Annual Meeting in National Harbor, Md (Press release, Advaxis, NOV 9, 2015, View Source [SID:1234508128]). The purpose of this study was to evaluate whether axalimogene filolisbac could be dosed at higher levels than previous studies conducted by Advaxis in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).

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While previous clinical studies of axalimogene filolisbac were evaluated at 1 x 109 CFU, data from this Phase 1 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 pre-clinically to correlate with increased antigen presentation and greater targeted anti-tumor activity.

Clinical data from the ongoing Phase 1/2 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, which will now constitute the randomized Phase 2 dose (RP2D). The adverse events observed at the high dose are consistent with previous experience.

"I’m extremely excited about this study because we have evaluated doses of axalimogene filolisbac at 5 and 10 times the level currently administered in the clinical trial program to date, with the goal of evaluating whether the increased dose and protein expression may lead to greater clinical benefit," said principal investigator Sharad Ghamande, M.D., Director of Gynecology Oncology at GRU Cancer Center, Georgia Regents University in Augusta, Ga. "Importantly, even at higher doses, the adverse event profile continues to be predominantly grade 1 grade 2, transient events, self-resolving within hours or resolving promptly with the introduction of anti-inflammatory medications."

The RP2D will now be explored further in an expansion cohort in subjects with PRmCC.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.