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
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
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. Patients have experienced mild and short-lived flu-like symptoms after the infusion of ADXS-504 at both the first and second dose levels.
The trial is currently expanding enrollment at the second dose level by up to six additional patients for a total of nine patients. The study investigators will evaluate the immunogenicity data after all of the patients at the higher dose level have completed the study treatment.
ADXS-504 is a novel Lm-based immunotherapy, bioengineered to elicit T cell responses against 24 tumor antigens, including 14 peptide antigens derived from hotspot mutations in patients with prostate cancer and 10 peptide antigens derived from sequence-optimized tumor-associated antigens (TAAs) that are differentially expressed or overexpressed in prostate cancer. ADXS-504 is designed to express multiple tumor antigen targets, potentially leading to generation of a broad set of effector T cells and NK cells that may enhance tumor control. Similar to Advaxis’s other Lm-based immunotherapies, ADXS-504 is expected to induce an innate immune response followed by the adaptive response and modification of the immunosuppressive tumor microenvironment (TME) by reducing regulatory T cells (Tregs) and myeloid-derived suppressor cell (MDSC) frequencies in the TME.
“We have completed evaluation of the dose-limiting-toxicity period for three patients at the second dose level for this Phase 1 trial of ADXS-504. At both the first and at this higher dose level, patients have experienced mild and short-lived flu-like symptoms after the infusion of ADXS-504,” said
About
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates. These and other risks are discussed in the Company’s filings with the
Contact:
212.915.2564
tim@lifesciadvisors.com

Source: Advaxis, Inc.