On May 9, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others (Press release, Aadi Bioscience, MAY 9, 2022, View Source [SID1234614205]). We expect these collaborations to expedite patient identification for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes.
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Neil Desai, PhD, Founder, President and Chief Executive Officer of Aadi, stated, "We are very pleased to have these leading NGS partnerships in place. Recently published data project an incidence of approximately 12,000 advanced cancer patients with TSC1 or TSC2 definite impact alterations in the US. These collaborations should help physicians to identify patients who may be candidates for nab-sirolimus in our PRECISION 1 registrational trial. We expect to report preliminary data from this trial in the first half of next year."
Loretta Itri, M.D., Chief Medical Officer of Aadi, stated, "We are excited to announce partnerships with the leading molecular diagnostic companies, including Foundation Medicine, Tempus and others. Many of our clinical trial sites had already been utilizing the NGS reports provided by these companies. Now our partnerships will allow us to also leverage their established patient enrollment programs, which we believe will significantly augment our efforts to identify and recruit patients with TSC1 and TSC2 alterations for our PRECISION 1 registrational trial. We are pleased with our progress to-date and remain confident we will meet our enrollment goals."
These partners will collect and analyze clinical and molecular data to determine which patients may be eligible to participate in Aadi’s PRECISION 1 clinical trial. The goals are to increase patient match rate, reduce screen failure rate and increase speed of enrollment into the trial.
About the PRECISION 1 Trial
The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient on the PRECISION 1 trial was dosed in March 2022.