PDS Biotech Announces Initiation of Phase 2 Trial of PDS0101 in Combination with Standard of Care Chemoradiotherapy in Advanced Cervical Cancer
PDS Biotech progresses second Phase 2 human clinical trial of PDS0101
FLORHAM PARK, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- 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 that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open.
This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.
“We are excited to have initiated this Phase 2 human study of PDS0101 administered with the current standard of care. We believe that the demonstrated potential of PDS0101 to activate the immune system to induce tumor-targeting T-cells provides strong potential to present improved treatments to patients with cervical cancer,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.
Dr. Lauren Wood, PDS Biotech’s Chief Medical Officer, will serve as PDS Biotech’s liaison. The study is being performed pursuant to an Investigator Initiated Study Agreement between PDS Biotech and MD Anderson.
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.
PDS Biotech’s lead clinical product, PDS0101, combines the utility of the Versamune® platform with targeted antigens against HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is has initiated a phase 2 study studying a combination of PDS0101 and two clinical-stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers.
Forward Looking Statements
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