Sujit Nair, PhD Director of GU Immunotherapy Research Department of Urology Icahn School of Medicine at Mount Sinai

AACR24: Icahn Mt. Sinai Study of Autovaccination Turns Cold Prostate Cancer Cells Hot Interview with:

Sujit Nair, PhDDirector of GU Immunotherapy Research Department of Urology Icahn School of Medicine at Mount Sinai

Dr. Nair

Sujit Nair, PhD
Director of GU Immunotherapy Research
Department of Urology
Icahn School of Medicine at Mount Sinai What is the background for this study? How is the vaccine obtained?


Dr. Tewari is the treating physician and clinical lead on the study.  This is a phase I, open-label, clinical trial (NCT03262103) using a dose escalation strategy in 12 patients diagnosed with clinically localized prostate cancer with plans for surgery. The investigational agent used in the trial is Poly-ICLC, an immune modulator developed by ONCOVIR. Poly-ICLC is a double-stranded RNA that mimics viral activity, thereby stimulating the immune response. What are the main findings?

Response:  Poly-ICLC was safely administered and well tolerated by all 12 patients. There were no dose-limiting toxicities or withdrawals during treatment. Eight of 10 evaluable patients (80%) had undetectable PSA(PSA<0.1 ng/ml) at 1 year of follow-up surgery . In 8 of 12 evaluable patients (66.7%) Gleason score was downgraded in the surgery specimen.

The intervention resulted in a significant increase in the expression of genes associated with positive prognostic outcomes, alongside a decrease in the expression of genes linked to cancer progression. Notably, the administration of Poly-ICLC induced anti-tumor immune responses in both tissue and peripheral blood compartments, as evidenced by substantial immune infiltration observed in surgical specimens. Moreover, the presence of tertiary lymphoid structures, known for their enhanced responsiveness to immunotherapy, was also observed. What should readers take away from your report?

Response: This is the first-in-human clinical trial to demonstrate that intratumoral-immunotherapy is feasible for Prostate Cancer  and that Poly-ICLC treatment can reliably transform the cold microenvironment of PCa into a hot, immune-enhanced ecosystem.

The baseline and response biomarkers, TLS, potential clinical benefit, and immunologic correlates identified here require validation in larger investigations. What recommendations do you have for future research as a results of this study?

Response: We are currently enrolling patients for a novel Phase-II clinical trial evaluating the efficacy of Poly-ICLC in intermediate-risk prostate cancer patients undergoing active surveillance. This trial is registered under the identifier NCT06343077 on

Furthermore, we are in the process of developing two additional studies to explore the synergistic effects of Poly-ICLC in combination with ablation therapies, such as High-Intensity Focused Ultrasound (HIFU) and Galvanize.

For our cohort of high-risk and very high-risk patients, we are designing a randomized controlled Phase II trial. This study aims to investigate the therapeutic potential of Poly-ICLC as a standalone intervention or in combination with checkpoint therapy.

Disclosures; The study was supported by funding from the Arthur M Blank Family Foundation and the Deane Prostate Health, ISMMS.

Citation: AACR24: Clinical Trials Minisymposium
CT023 Prostate cancer in situ autovaccination with the intratumoral viral mimic poly-ICLC: Making a cold tumor hot. Sujit S. Nair, New York, NY

The information on is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition.

Some links may be sponsored. Products are not endorsed.

Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.



Last Updated on April 8, 2024 by Marie Benz MD FAAD