Advaxis, Inc. (NASDAQ:ADXS), 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 in National Harbor, Md. 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).
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. (Original Source)
Shares of Advaxis closed last Friday at $13.63 . ADXS has a 1-year high of $30.13 and a 1-year low of $2.70. The stock’s 50-day moving average is $11.69 and its 200-day moving average is $17.09.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on October 5, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which implies an upside of 120.1% from current levels. Separately, on September 14, FBR’s Vernon Bernardino maintained a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Vernon Bernardino have a total average return of -11.5% and -18.3% respectively. Ramakanth has a success rate of 25.0% and is ranked #3724 out of 3829 analysts, while Bernardino has a success rate of 27.2% and is ranked #3800.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.