Cardiff Oncology(US:CRDF)2020-12-15 15:51Onvansertib: A Promising Cancer Therapy - Onvansertib is a 3rd generation, 1st-in-class, oral PLK1 inhibitor with high selectivity and a 24-hour half-life, targeting a key mechanism of cell division required for tumor cell viability[2,8,11] - Clinical data supports the use of onvansertib in combination regimens across numerous aggressive cancers, including mCRC, mCRPC, and AML[2] - The company has a diversified pipeline across numerous cancers and an integrated biomarker strategy, including circulating tumor DNA and circulating tumor cells, to predict therapeutic response[2,5] mCRC (Metastatic Colorectal Cancer) Program - In a Phase 1b/2 trial in KRAS-mutated mCRC, preliminary clinical data showed a ten-fold improvement in Overall Response Rate (ORR) compared to Standard of Care (SOC)[2] - Current second-line standard-of-care treatment in KRAS-mutated mCRC has an overall response rate of 4% and progression-free survival (PFS) of 5.5 months[17] - In the Phase 1b/2 trial, 10 of 11 (91%) patients had clinical benefit, with 5 (45%) patients achieving a partial response (PR)[42] - Monitoring KRAS mutations in plasma ctDNA may enable rapid predictions of therapeutic response, with the greatest changes in KRAS observed in patients achieving a PR[47] mCRPC (Metastatic Castration-Resistant Prostate Cancer) Program - Resistance develops to treatment with standard of care ARSi's within 9-15 months, and ARSi's offer a median overall survival (mOS) benefit of only ~4 months[52] - Phase 2 data demonstrated that 5 (29%) in Arm A, 3 (33%) in Arm B and 2 (67%) in Arm C achieved disease control at 12 weeks[64] - In the Phase 2 trial, 5 (50%) patients had an ≥80% CTC decrease, and 4 (40%) patients converted from unfavorable to favorable CTC level[68] Corporate Information - As of October 31, 2020, the company had $131.8 million in cash and cash equivalents, with an average quarterly cash burn of $3.8 million for Q1-Q3 2020[88]