Cardiff Oncology (CRDF) Jefferies 2024 Global Healthcare Conference summary

Strategic focus and clinical development

• Targeting first-line RAS-mutated metastatic colorectal cancer with onvansertib, a selective PLK1 inhibitor.

• Pivoted clinical development from second-line to first-line based on robust trial data and FDA recommendations.

• Pfizer investment and operational support through Pfizer Ignite for ongoing first-line trial.

• Initial data from the first-line trial expected later this year; cash runway extends into Q3 2025.

Scientific rationale and mechanism of action

• Onvansertib is highly selective for PLK1, showing strong tolerability in over 300 patients across seven trials.

• Addresses a significant unmet need, as 50% of metastatic colorectal cancer patients have RAS mutations and lack targeted therapies.

• Demonstrates activity across all RAS mutations, not limited to G12C.

Clinical trial insights and efficacy

• Phase 1b/2 single-arm trial in second-line RAS-mutated patients showed a 73% response rate in bevacizumab-naive patients, nearly triple historical controls.

• Median progression-free survival (PFS) in bev-naive patients was 15 months, almost double historical benchmarks.

• No bias detected in patient characteristics; efficacy attributed to scientific mechanism.