According to the National Cancer Institute, prostate cancer is one of the most common cancers in men in the U.S., second only to skin cancer, and is the second leading cause of death in men.1 Roughly 14 percent of men will be diagnosed with prostate cancer at some point.2 In 2015, about 220,800 men were expected to be diagnosed in the United States.3
PSA: THE NEED
ADXS-PSA is under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer, and is in clinical development for the treatments of metastatic castration-resistant prostate cancer (mCRPC).
1 National Cancer Institute. Prostate Cancer: for patients. Retrieved June 1, 2017 from http://www.cancer.gov/types/prostate
2 National Cancer Institute. SEER Stat Fact Sheets: Prostate Cancer. RetrievedJune 1, 2017 from http://seer.cancer.gov/statfacts/html/prost.html
3 American Cancer Society. Prostate Cancer [Fact sheet]. Retrieved June 1, 2017 from http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics
LEADING DRUG CANDIDATES
ADXS-PSA is under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatments of metastatic castration-resistant prostate cancer (mCRPC).
ADXS-PSA is being evaluated in the Phase 1/2 KEYNOTE-046 study of ADXS-PSA as a monotherapy and in combination with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab) in 51 patients with mCRPC. The trial has completed dosing cohorts in Part A (dose escalation) of the trial with ADXS-PSA as a monotherapy, the first in-human study of this product candidate in prostate cancer. Enrollment for Part B will commence mid-year, evaluating ADXS-PSA in combination with KEYTRUDA®, followed by an expansion cohort phase. The primary objective is to evaluate the safety and tolerability of the two immunotherapies, with the secondary objective of evaluating anti-tumor activity and progression-free survival.