FLORHAM PARK, NJ, USA I June 04, 2020 I PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced a Phase 2 clinical trial to evaluate its lead immunotherapy product, PDS0101, in combination with standard of care chemoradiotherapy for treatment of locally advanced cervical cancer.

The clinical trial will be conducted at The University of Texas MD Anderson Cancer Center and the Lyndon B. Johnson Hospital in Houston by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D. The clinical trial will investigate the safety and anti-tumor efficacy of the PDS0101-chemoradiation combination, and their correlation with critical biomarkers of an immune response in patients with locally advanced cervical cancer. 

On September 19, 2019, PDS Biotech announced the results of a PDS0101 Phase 1 clinical study in cervical neoplasia (pre-cervical cancer) patients.  PDS0101 is being developed to treat multiple cancers associated with HPV infection, including anal, cervical and head and neck cancers.  In the Phase 1 study, PDS0101 demonstrated potent in vivo induction of active killer T-cells that target cancer cells containing the cancer-causing HPV proteins, as well as an excellent safety profile with no limiting toxicities.  Treatment with PDS0101 resulted in complete lesion regression in most of the patients. HPV infection is responsible for over 99% of cervical cancers.  PDS Biotech currently anticipates initiating this clinical study within a few months.

“We are pleased to announce this Phase 2 clinical trial being performed to further validate our novel Versamune®-based immunotherapy platform and lead asset PDS0101,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “We look forward to investigating PDS0101 as a potentially safe and effective immunotherapeutic combination with standard of care chemoradiotherapy to improve the treatment options for women with locally advanced cervical cancer.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In separate partnerships with Merck and Co. and the National Cancer Institute (NCI), PDS Biotech is preparing to initiate two additional Phase 2 studies in head and neck cancer and in HPV-related advanced cancer respectively.

SOURCE: PDS Biotechnlogy