Clinical Trials SetbackThe shift in development results in a major setback for BOLD's lead program, as the agent returns to proof-of-principle and dose-optimization efforts and novel combination strategies to improve the therapeutic index.
Diagnostic DelaysThe validation of the ecDNA hypothesis with the ECHO diagnostic tool has also been delayed, suggesting the investment thesis may remain in limbo until a new asset, such as the BBI-940, is developed.
Therapeutic ChallengesCombinations of BBI-355 with erlotinib (EGFR) and futibatinib (FGFR) were also not well-tolerated at the Q2D doses required for anti-tumor activity.