Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced that its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), has been classified as an advanced-therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (CAT).
“Classification of AXAL as an ATMP is reflective of a groundbreaking new opportunity for the treatment of HPV-associated cancers,” said Robert Ashworth, PhD, Vice President, Regulatory Affairs. “Building upon the approach endorsed at Advaxis’ meetings with National Competent Authorities earlier this year, it allows us to take advantage of a specific EU regulatory framework, akin to fast-track in the United States, designed to facilitate the review, approval, and access of AXAL in the EU market.” In the next phase of this regulatory process, CAT assessment of currently available quality and non-clinical data may help resolve some issues prior to the submission of a marketing-authorization application (MAA).
The Committee for Advanced Therapies is the committee at the European Medicines Agency that is responsible for classifying and assessing the quality, safety and efficacy of advanced-therapy medicinal products and following scientific developments in the field. It is a multidisciplinary committee, gathering together some of the best available experts in Europe. The ATMP designation is a classification for certain medicines for human use that are gene-, cell-, or tissue-based. The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the European Medicines Agency, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on granting a marketing authorization for the product. During drug development, CAT also reviews and certifies the acceptability of quality and non-clinical data.
Advaxis’ immunotherapies, including AXAL, are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Advaxis’ core technology – Lm Technology™ – alters a live strain of Listeria monocytogenes bacteria to generate cancer fighting T-cells directed against a cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. AXAL has Orphan Drug Designation in Europe for treatment of anal cancer. (Original Source)
Shares of Advaxis closed last Friday at $8.14, up $0.02 or 0.25%. ADXS has a 1-year high of $22.20 and a 1-year low of $5.21. The stock’s 50-day moving average is $8.50 and its 200-day moving average is $8.02.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on July 6, FBR analyst Vernon Bernardino reiterated a Buy rating on ADXS. Separately, on June 29, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $23.
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 -16.6% and -17.0% respectively. Bernardino has a success rate of 27.6% and is ranked #3949 out of 4058 analysts, while Ramakanth has a success rate of 24.5% and is ranked #3938.
The street is mostly Bullish on ADXS stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $21.00, which implies an upside of 158.0% from current levels.
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.