Study of ADXS-504 Monotherapy to Enroll More Patients With Early Prostate Cancer

The phase 1 study evaluating ADXS-504 monotherapy (NCT05077098) for the treatment of early prostate cancer is expanding enrollment to include 6-9 more patients with early prostate cancer who will receive the second experimental dose level of the drug, announced Advaxis, Inc, in a press release.¹

The enrollment expansion comes just after the completion of the dose-escalation phase of the study. Treatment with ADXS-504 in the study has been well-tolerated in patients, and no serious adverse events (AEs) have been observed.

“We have completed evaluation of the dose-limiting-toxicity period for 3 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 Karie Runcie, MD, assistant professor of medicine in the division of hematology/oncology at Columbia University Vagelos College of Physicians and surgeons at the Herbert Irving Comprehensive Cancer Center, in the press release. “The safety of ADX-504 and encouraging early data led to our decision to increase enrollment at the second dose level to better characterize its clinical activity.”

ADXS-504 is a live attenuated Listeria monocytogenes-based immunotherapy and was designed to aid expression of targeted hotspot mutation peptide antigens. By amplifying expression of these mutations, ADXS-504 can potentially induce antigen-specific T cell responses and delay or prevent the need for androgen deprivation therapy (ADT) in patients with early prostate cancer. ADT is known to be effective but has long-lasting AEs. Therefore, alternatives to ADT are need, according to Runcie et al.²

To assess the safety and tolerability of ADXS-504, level 2 includes a dose of 1 × 10⁸ CFU every 4 weeks with an additional 3 days of treatment during weeks 1 and 21. Maintenance therapy is also administered during the study every 12 weeks for 4 doses. In addition to safety/tolerability, the study will summarize prostate specific antigen (PSA) response and PSA doubling time.

Adult patients with early prostate cancer are eligible for enrollment if they have an ECOG performance status of 0 or 1, histologically documented disease, and have previously been treated for prostate cancer. Patients are also required to have a low-risk or biochemical recurrence, a rising PSA, testosterone ≥ 150 ng/dL, adequate bone marrow, hepatic, and renal function, and baseline blood oxygen saturation of ≥ 95% on room air.³

“We are excited that our collaborators at Columbia have elected to expand the enrollment of this phase 1 trial in ADXS-504,” stated Kenneth A. Berlin, president and chief executive officer of Advaxi, in the press release.¹ “We are also encouraged by the safety data, and we are actively collecting long-term PSA results from all the patients in this trial. We look forward to analyzing the composite data to gain further insight into the safety and efficacy of this novel therapy.”

_REFERENCES:

_{1. Advaxis updates on the phase 1 clinical trial of ADXS-504 for the treatment of early prostate cancer. News release. Advaxis, Inc. January 12, 2023. Accessed January 12, 2023. https://bit.ly/3Zz8C3y}

_{2. Runcie K, Dallos M, Khan S, et al. A phase I study of ADXS-504, a cancer type specific immunotherapy, for patients with biochemically recurrent prostate cancer. J Clin Oncol. 2022;40 (suppl 16). doi:10.1200/JCO.2022.40.16_suppl.TPS5115}

_{3. Study of ADXS-504 immunotherapy for recurrent prostate cancer. ClinicalTrials.gov. Updated October 14, 2021. Accessed January 12, 2023. https://clinicaltrials.gov/ct2/show/NCT05077098?term=ADXS-504&draw=2&rank=1}