PDS Biotechnology(US:PDSB)2022-06-14 12:49Company Overview - PDS Biotechnology has approximately $58.9 million in cash as of March 31, 2022, projected to fund operations into 2024[4] - PDS0101 has been granted Fast Track designation from the FDA[4] PDS0101 Clinical Trials - In the VERSATILE-002 trial, the Objective Response (OR) was 41.2% (7 out of 17 subjects with imaging data), including 2 Complete Responses (CR) and 5 Partial Responses (PR)[21] - In the VERSATILE-002 trial, Stable Disease (SD) was observed in 35.3% (6 out of 17) of subjects with imaging data, with reduction in 4 out of 6 cases[21] - In the VERSATILE-002 trial, the Progression Free Survival Rate (PSF) was 55.2% at 9 months of follow-up[25] - In the VERSATILE-002 trial, the Overall Survival Rate (OS) was 87.2% at 9 months of follow-up[25] - In the NCI-led triple combination trial, the Objective Response Rate (ORR) in CPI Refractory patients was 63% with high dose M9241[29] - In the NCI-led triple combination trial, tumor reduction was only seen in HPV16-positive patients (P<0.001)[30] - In the NCI-led triple combination trial, the Objective Response Rate (ORR) in CPI Naïve subjects was 83% with high dose M9241[36] - In the NCI-led triple combination trial, patient survival at median 17 months was 75% in CPI Naïve subjects[36] Market Opportunity - PDS0101 targets a $6 billion market opportunity in HPV16-associated cancers[14]