Advaxis Updates on the Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

Dose escalation has been completed and enrollment at second dose level will be expanded at Columbia University

ADXS-504 has been well tolerated with no serious adverse events reported
Four out of six patients treated are still on study and PSA values are being followed up

Excerpt from the Press Release:

MONMOUTH JUNCTION, N.J., Jan. 12, 2023 (GLOBE NEWSWIRE) — Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced an update on the Phase 1 clinical study evaluating ADXS-504, the company’s off-the-shelf neoantigen drug candidate, in patients with biochemically recurrent (early) prostate cancer that is being conducted at Columbia University Irving Medical Center. Karie Runcie, MD, assistant professor of medicine, and Mark N. Stein, MD, associate professor of medicine, in the division of hematology/oncology at Columbia University Vagelos College of Physicians and Surgeons and members of the Herbert Irving Comprehensive Cancer Center, are the study’s principal and senior investigators, respectively.

The study design of this phase 1 open-label dose escalation study for patients in both dose cohorts was presented at the 2022 ASCO Annual Meeting by Dr. Runcie (Abstract #: TPS5115). The clinical assessment of three patients at the first dose level (1e7 CFU) and three at the second dose level (1e8 CFU) has shown that ADXS-504 monotherapy is safe and well-tolerated.  

In this study, ADXS-504 is being administered via infusion every four weeks for a total of six doses, followed by four additional maintenance doses every twelve weeks, in patients with biochemically recurrent prostate cancer, i.e., those with elevation of prostate-specific antigen (PSA) in the blood after radical prostatectomy or radical radiotherapy (external beam or brachytherapy) and who are not currently receiving androgen ablation therapy.

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