ADXS-PSA is a potential candidate for the treatment of prostate cancer being developed by Advaxis. It is currently in clinical development as a standalone or combination therapy for metastatic castration-resistant prostate cancer.
Prostate cancer is the most common cancer in men in the U.S. and is the second leading cause of cancer death in men, according to the National Cancer Institute. The American Cancer Society estimates that about 161,360 new cases and about 26,730 deaths will occur from prostate cancer in the U.S. in 2017.
How ADXS-PSA works
ADXS-PSA uses Adaxis’ Lm Technology, an antigen delivery platform that activates the body’s own immune system to fight cancer.
Lm technology uses an attenuated strain of Listeria monocytogenes (Lm) bacteria that “infects” cells that produce prostate-specific antigen (PSA) and begins to secrete a fusion protein, stimulating specialized immune cells called T-cells to fight cancer and reduce factors that protect the tumors from immunologic attacks and that contribute to tumor growth.
A Phase 1/2 clinical trial (NCT02325557) called KEYNOTE-046 is assessing the safety and efficacy of ADXS-PSA as a standalone, or monotherapy, and in combination with Keytruda (pembrolizumab) in people with previously treated metastatic castration-resistant prostate cancer. The primary objective of the trial is to evaluate the safety and tolerability of both treatments. Secondary objectives include measures of anti-tumor activity and progression-free survival.
The trial aims to recruit a total of 51 patients and is currently recruiting at sites across the U.S. The estimated study completion date is December 2019.
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