Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced dose administration for the first patient in the first stage of its Phase 2 clinical trial of their FAWCETT study, testing the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic anal cancer.
The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1×109colony forming unit (CFU) doses every three weeks for up to two years.
In collaboration with Brown University Oncology Research Group, AXAL has been evaluated in high-risk, locally advanced anal cancer with concurrent standard chemotherapy and radiation treatment. Preliminary data show treatment with AXAL indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.
“The FAWCETT study is an important step in the development program for AXAL,” said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. “People living with anal cancer desperately need new treatment options, which is why Advaxis is pursuing two areas of evaluation, including monotherapy with AXAL and a second study with an immune checkpoint inhibitor in combination with AXAL.”
The FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy) study was named in honor of Farrah Fawcett, who passed away due to HPV-associated anal cancer. In 2015, the Farrah Fawcett Foundation honored Advaxis with its inaugural “Medical Visionary Angel Award” based on the Company’s clinical research and efforts to treat this disease, initiating a partnership among the organizations. (Original Source)
Shares of Advaxis closed yesterday at $9.26, down $0.34 or -3.54%. ADXS has a 1-year high of $25.40 and a 1-year low of $5.21. The stock’s 50-day moving average is $8.35 and its 200-day moving average is $8.60.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on May 17, Janney Montgomery Scott analyst Roy Buchanan maintained a Buy rating on ADXS, with a price target of $22, which implies an upside of 137.6% from current levels. Separately, on May 16, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $34.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Roy Buchanan and Vernon Bernardino have a total average return of -4.5% and -11.9% respectively. Buchanan has a success rate of 37% and is ranked #3120 out of 3903 analysts, while Bernardino has a success rate of 35% and is ranked #3854.
Advaxis, Inc. is a clinical-stage biotechnology company, which intends to develop immunotherapies for cancer and infectious diseases. The company’s platform technology is designed to generate a comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor.