NCI meets target enrollment of 30 patients in the refractory checkpoint inhibitor arm
FLORHAM PARK, NJ, March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly targeted cancer therapies and infectious disease vaccines based on the company’s Versamune® and Infectimune™ T-cell activation technologies announced today that the National Cancer Institute (NCI) has met its intended enrollment goal of 30 patients in the refractory checkpoint inhibitor (CPI) arm of the NCI-led Phase 2 clinical trial (NCT04287868). has PDS0101 (Versamune®+HPV16mix) in combination with two immunomodulating test substances in advanced HPV-associated cancer. Currently, the study has enrolled 45 patients and will continue to enroll both CPI-refractory and CPI-naïve patients until the total enrollment of 56 is reached.
The study evaluates the novel triple combination in two patient groups. First, in the second-line treatment of recurrent or metastatic HPV-positive cancers, including anal, cervical, head and neck, penile, vaginal, and vulvar cancer in patients not treated with CPIs (CPI-naïve) and at least one Standard of failed nursing therapy. Second, in the third-line treatment of the recurrent or metastatic HPV-positive cancers listed above in patients who have failed at least two standard therapies including CPI treatment (CPI-refractory).
The NCI, part of the National Institutes of Health, presented promising preliminary efficacy and safety data from the study at the American Society of Clinical Oncology (ASCO) conference in June 2021. The NCI plans to provide an update in the near future. Earlier this year it was reported that the median survival of these patients now exceeds 12 months.
“We are pleased that the NCI has achieved this important milestone, as CPI-refractory patients with various HPV-associated cancers have very few effective treatment options and study data have demonstrated the potential to prolong the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all their efforts in achieving this recruitment goal.”
Patients interested in participating in this clinical study should call NCI toll-free 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and send an email to [email protected] nih.gov and/or visit: https://trials.cancer.gov.
About PDS Biotechnology
PDS Biotech is a clinical stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies for cancer and infectious diseases based on the company’s Versamune® and Infectimune™ T-cell activating technology platforms.
Our versamune®-based targeted products have shown the potential to overcome the limitations of current induction-based immunotherapy in vivo, large quantities of high-quality, highly potent polyfunctional tumor-specific CD4+ helper and CD8+ killer T cells. PDS Biotech has developed several therapies based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products treat multiple cancers, including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar), breast, colon, lung, prostate and cancer ovarian cancer.
Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also potent T-cell responses, including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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