FAILED TRIAL: PRECISION1 trial of nab-sirolimus in patients with solid tumors with TSC1/2 inactivating mutations to be halted as study unlikely to exceed the efficacy threshold 

“We are humbled by the effort of the investigators, support staff, and most importantly, the patients and their families who took part in PRECISION1. While nab-sirolimus showed monotherapy activity in the study population, the trial fell short of delivering what we believe would be required to support an accelerated approval in the broad TSC1/TSC2 inactivating mutations indication. We look forward to providing the full trial analysis at a later date,” said David Lennon, President and CEO of Aadi Bioscience. “I want to thank the dedicated Aadi employees who worked tirelessly on this trial and are negatively impacted by this outcome. Given the change in the development pipeline, we have taken the necessary steps to immediately preserve cash runway, and have hired an advisory firm to explore all options to maximize value for shareholders.”

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