Advaxis, Inc. (NASDAQ: ADXS) a biotechnology company in the clinical stage concentrated on developing immunotherapy products, announced the initiation of its Phase 1 clinical study of ADXS-504 in patients with recurrent prostate cancer on July 15, 2021. The clinical study being executed at Irving Medical Center, Columbia University, is the first clinical evaluation of ADXS-504, Advaxis’ off-the-shelf neoantigen immunotherapy drug aspirant for prostate early-stage cancer. Moreover, the study’s principal investigator is Mark Stein, M.D., associate professor of medicine in the Division of Hematology at Columbia University.
Dr. Andrea Gutierrez’s Statement
Chief Medical Officer of Advaxis, Dr. Andrea Gutierrez, said that analyzing ADXS-504 in patients with biochemically recurrent prostate cancer is the initial step in experimenting. Maybe Lm-based immunotherapies have a role in the adjustable setting in cancer patients who have undergone radical treatment and have no noticeable primary tumor enrollment.
Moreover, he adds that Phase 1 research will analyze the safety, immunogenicity, and clinical activity of ADXS-504 in people who have undergone radical prostatectomy and radiotherapy. Their prostate-specific antigen level in the blood is rising to speculate ideal patients to analyze with this study.
Furthermore, they believe that their multi neoantigen can drive T cell responses against both hormone-resistant and hormone-sensitive cancer cells, resulting in controlling disease and delaying the start of androgen blockade therapy and its long-term complications. The observation will also evaluate their lowest dose of Lm-based immunotherapy up to date, which could improve the benefit ratio that they have previously examined in their ADXS-HOT program.
Advaxis, a biotechnology firm, mainly concentrated on commercializing and improving proprietary Lm-based antigen products. These products are based on the platform tech that employs live attenuated Listeria monocytogenes bioengineered to emit antigen fusion products. These Listeria Monocytogenes based strains are an essential advancement in immunotherapy. They integrate multiple functions into single immunotherapy and are designed to access antigen-presenting cells to stimulate anti-tumor T cell immunity and generate the immune system with an equal amount of multiple adjuvants.