Jared Weiss, MD, associate professor of medicine in the division of hematology and oncology, and researcher with UNC Lineberger Cancer Center, will lead an advancing Phase 2 study that evaluates the efficacy and safety of PDS Biotech’s Versamune®-based immunotherapy, PDS0101–in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)–in the first-line treatment of patients with recurrent or metastatic human papillomavirus-16 (HPV16) positive head and neck cancer. The study is expected to begin in first quarter 2020.
“This study has the potential to play a critical role in expanding the clinical efficacy of these therapies to a much broader population of patients,” said Weiss, who has served as principal investigator on numerous industrial and investigator initiated immunotherapy clinical trials.
“PDS0101 is an investigational cancer vaccine believed to stimulate the immune system to fight cancer. It has a unique ability to promote the in-vivo induction of high levels of HVP16-specific CD8+ killer T-cells, and it may help overcome a significant limitation of checkpoint inhibitors.”
Weiss is an advocate for patient and family education about cancer, serving as vice president of cancergrace.org and board member of the Lung Cancer Initiative of North Carolina. Weiss received his medical degree from Yale University School of Medicine, and bachelor of science in neuroscience from Brown University. He completed his residency in internal medicine at Beth Israel Deaconess Medical Center, and his medical oncology fellowship at the Hospital of the University of Pennsylvania.
Phase 1 of the PDS0101 trials were completed last year, in people with cervical neoplasia infected with high-risk cancer-causing strains of HPV. The study showed PDS0101 overcame a key immunotherapy limitation by accessing an immunologic pathway that trains and activates killer T-cells to target cancer proteins.
About PDS Biotechnology
PDS Biotechnology is a clinical-stage immuno-oncology company developing multiple therapies based on the Versamune® T-cell activating technology platform. Using Versamune®, PDS Biotechnology is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotechnology’s pipeline combines the Versamune® technology with tumor-specific antigens across several cancer types.
PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck and the National Cancer Institute (NCI), PDS Biotechnology is advancing PD0101 to Phase 2 studies in head and neck cancer and in HPV-related advanced cancer.