By Michael Dabaie

PDS Biotechnology Corp. (PDSB) said it reviewed limited available patient clinical outcome data from its previously reported Phase 1 study of PDS0101.

The primary focus of the study was safety and evaluation of immune biomarkers from administration of Versamune-based PDS0101 in patients with cervical intraepithelial neoplasia infected with multiple high-risk, cancer-causing types of human papillomavirus. In the study, 60% of evaluable patients had a clinical response and clinical activity was observed at all dose levels, PDS said.

PDS said that starting in the first quarter of 2020, it anticipates initiating three studies: a Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3; a Phase 2 study in collaboration with Merck & Co. (MRK) to evaluate PDS0101 in combination with Keytruda for of HPV16-positive head and neck cancer; and a Phase 2 study to evaluate PDS0101 in combination with two other immunotherapies in advanced HPV-associated cancers.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

September 19, 2019 08:37 ET (12:37 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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