Pharma Focus Asia

PDS Biotechnology Completes Manufacturing of Clinical Batches of PDS0101

Wednesday, October 23, 2019

PDS Biotechnology Corporation, a clinical-stage immuno-oncology company pioneering development of multi-functional novel immunotherapies, today announced that it has completed manufacturing of clinical batches of PDS0101 with its partner BSP Pharmaceuticals S.p.A, a leading manufacturer of anticancer drugs.

The clinical batches of PDS0101 will be used in the Company’s two upcoming Phase 2 studies, which are expected to start in the first quarter of 2020. The trials include a combination study with Merck to evaluate PDS0101 in combination with KEYTRUDA® in first-line treatment of head and neck cancer and a study to evaluate PDS0101 in combination with two novel clinical-stage immunotherapies in advanced HPV associated cancers with the National Cancer Institute.

“We are pleased to have completed the manufacturing of the clinical batches of PDS0101 with our partner BSP Pharmaceuticals and are honored to be collaborating with two leaders in the field of immuno-oncology,” said Dr. Frank Bedu-Addo, CEO of PDS. “Based on our recently announced Phase 1 clinical outcome data which demonstrated PDS0101’s unique ability to promote the in-vivo induction of high levels of HPV-specific CD8+ killer T-cells as well as the regression of pre-cancerous lesions in 60% of patients, we believe that PDS0101 could expand the clinical efficacy of checkpoint inhibitors such as KEYTRUDA®. We are now working diligently to qualify clinical sites for our combination trial with KEYTRUDA® in first line treatment of head and neck cancer and look forward to initiating both our planned combination trials by the first quarter of 2020.”

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