Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the Farrah Fawcett Foundation honored Advaxis with the Foundation’s inaugural “Medical Visionary Angel Award” on September 9, 2015, at the Wallis Annenberg Center for the Performing Arts in Beverly Hills, Calif. The event benefitted the Farrah Fawcett Foundation / Stand Up To Cancer (SU2C) research team on HPV-related cancers and celebrated the life and legacy of actress Farrah Fawcett and her commitment to fund research for a cure for anal cancer, which took her life in 2009.
Advaxis also announced plans to commence enrollment this fall of a Phase 2 clinical study of Advaxis’s lead investigational Lm Technology™ immunotherapy, axalimogene filolisbac (ADXS-HPV), in metastatic anal cancer. The study is to be called FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy), in honor of Farrah Fawcett, and will be the company’s second Phase 2 study of axalimogene filolisbac in anal cancer. The two-part, single-arm, open-label study is designed to evaluate the efficacy and safety of axalimogene filolisbac as monotherapy in patients with human papillomavirus (HPV)-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease.
“We would like to thank the Farrah Fawcett Foundation for this honor,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “While there is still so much work to be done in this space, we are unwavering in our commitment to bring new treatments to market in anal cancer and other underserved HPV-associated cancers.”
The FAWCETT study will enroll approximately 31 patients in Part A and approximately 24 patients in Part B. The primary efficacy endpoints include overall response rate and progression-free survival, and the secondary endpoints include evaluation of overall response rate and the safety/tolerability of the dose. Further information about the Phase 2 study can be found on ClinicalTrials.gov, using Identifier NCT02399813.
The Farrah Fawcett Foundation’s “Medical Visionary Angel Award” is intended for companies that have demonstrated an outstanding commitment to innovative research in anal cancer and HPV-related cancers. Advaxis was selected for the award due to the company’s collaboration with Brown University Oncology Group on a Phase 1/2 clinical study conducted by Howard Safran, M.D., investigating axalimogene filolisbac in HPV-associated locally advanced anal cancer. The preliminary data showed treatment with axalimogene filolisbac indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.
“When the Farrah Fawcett Foundation first invested in the cancer research at Brown University, we did so with great enthusiasm, knowing the work of Dr. Safran and appreciating the collaboration with Advaxis,” said Alana Stewart, President and CEO of the Farrah Fawcett Foundation. “Now we are proud to honor Advaxis for their continued research on underserved cancers and breakthrough discoveries in the treatment of anal cancer and other HPV-associated cancers.”
The Brown University Oncology Group study has the potential to transition into a pivotal Phase 2/3 clinical trial in collaboration with the Radiation Therapy Oncology Group (RTOG) Foundation and NRG Oncology to evaluate the safety and efficacy of axalimogene filolisbac with or without chemotherapy and radiation as adjuvant treatment in high-risk, locally advanced anal cancer. (Original Source)
Shares of Advaxis Inc closed yesterday at $13.86. ADXS has a 1-year high of $30.13 and a 1-year low of $2.50. The stock’s 50-day moving average is $15.32 and its 200-day moving average is $17.53.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on August 7, MLV & Co. analyst Vernon Bernardino initiated coverage with a Buy rating on ADXS and a price target of $34, which represents a potential upside of 145.3% from where the stock is currently trading. Separately, on June 26, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $30.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Swayampakula Ramakanth have a total average return of -17.8% and -6.8% respectively. Bernardino has a success rate of 20.8% and is ranked #3722 out of 3752 analysts, while Ramakanth has a success rate of 22.9% and is ranked #3470.
Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.