PDS Biotechnology(US:PDSB)2021-05-14 18:19Company Overview - PDS Biotech is a clinical-stage biotechnology company focused on developing immunotherapies based on the Versamune® platform[6] - As of March 31, 2021, PDS Biotech reported approximately $25 million in cash and is debt-free[7] - The company has approximately 15 employees and is headquartered in Florham Park, NJ[7] Versamune® Platform - Versamune®-based immunotherapies promote a powerful in vivo tumor-specific CD8+ killer T-cell response and generate a strong CD8+ T-cell memory response[5] - Preclinical studies showed that Versamune® induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose[44] - Phase 1 clinical trial data showed a >20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs pre-treatment at day 14, leading to rapid clearance of lesions[47] Clinical Development Programs - PDS Biotech has three Phase 2 oncology clinical trials in progress with initial data releases expected in 2021[7] - PDS0101 is being developed in combination with Keytruda® for first-line treatment of recurrent/metastatic HPV-positive head and neck cancer, where KEYTRUDA (Standard of Care) has an ORR of ~20%[12, 64] - A Phase 2 trial is evaluating PDS0101 in combination with chemoradiation therapy in patients with advanced cervical cancer[68] - PDS0203, a Versamune®-based COVID-19 vaccine, is under development with funding of up to approximately $60 million from MCTI, Brazil to support Phase 1-3 clinical development and manufacturing scale-up[87]