PDS Biotech Announces Clinical Trial With Mayo Clinic to Study PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head & Neck Cancer

PDS Biotechnology Corporation recently announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA, in patients with HPV-associated oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

HPV(+)OPSCC is now the most common type of head and neck cancer and has been increasing significantly in recent years.  Oropharyngeal cancer is a disease in which cancer cells form in the tonsil tissues of the back (base of tongue) and side (palatine tonsils) of the throat. According to the National Cancer Institute, smoking or being infected with the human papillomavirus (HPV), especially HPV16, can increase the risk of oropharyngeal cancer. The American Cancer Society estimates there are over 54,000 new cases of oral and oropharyngeal cancer and over 11,000 related deaths in the US, annually.

“We are excited to have a team of doctors at Mayo Clinic conducting a trial to study our novel Versamune-based T cell immunotherapy platform and lead asset, PDS0101 in earlier-stage disease,” said Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “This upcoming trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with KEYTRUDA in earlier stages of disease.”

The study treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T-cells that target and kill HPV-positive cancers, either alone or in combination with checkpoint inhibitors in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-associated cancers.  This study will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune and Infectimune T-cell activating technology platforms.

Our Versamune-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple 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 address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers.

Our Infectimune-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. For more information, visit www.pdsbiotech.com.