Oncolytics Biotech (US:ONCY)2019-06-07 15:50Pelareorep Clinical Development and Advantages - Pelareorep is a clinical-stage immuno-oncolytic virus delivered intravenously, promoting an inflamed tumor phenotype through immune responses[5, 8] - It is the first IV-delivered immuno-oncolytic virus to demonstrate an overall survival benefit in a randomized study[5, 14] - A predictive and prognostic biomarker derived from a simple blood draw was correlated with clinical response in a second-line pancreatic cancer study[9] - Pelareorep has competitive advantages including ease of intravenous delivery, standard dosing, and access to metastatic disease[16] - The company has identified a predictive and prognostic biomarker, making Pelareorep the only oncolytic virus with a biomarker[17] Breast Cancer Studies and Strategy - A Phase 2 metastatic breast cancer study (IND-213) showed a statistically significant increase in overall survival (OS)[10, 23] from 104 months to 174 months in the ITT population (HR = 065, p = 01)[23] - In HR+/HER2- breast cancer patients, the median OS improved from 108 months to 210 months (HR = 06, p = 01)[23] - In PgR+/HER2- breast cancer patients, the median OS improved from 108 months to 218 months (HR = 036, p = 0003)[23] - The company plans to initiate a Phase 3 registration study in metastatic breast cancer after a window of opportunity study[79] Partnerships and Financials - The company has an established partnership with Adlai Nortye to develop the Chinese market, with potential upfront and milestone payments of up to $866 million[11, 65] - The company reported CDN $142 million (USD $106 million) in cash and cash equivalents as of Q1 2019, with a financial runway of over 12 months[74]