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Aadi Bioscience Announces First Patient Dosed in its PRECISION 1 Phase 2 Registrational Trial of nab-Sirolimus in Patients with Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 Genes
FDA grants Fast Track designation for nab-sirolimus for the treatment of adult and adolescent patients with Tuberous Sclerosis Complex 1 and 2 (“TSC1” and
About this update from Whitehawk Therapeutics, Inc.
[{"type":"text","content":"FDA grants Fast Track designation for nab-sirolimus for the treatment of adult and adolescent patients with Tuberous Sclerosis Complex 1 and 2 (“TSC1” and “TSC2”) alterations\nLOS ANGELES, March 31, 2022 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. (Nasdaq: AADI), a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the commencement of dosing in PRECISION 1, a Phase 2 registrational trial of nab-sirolimus in patients 12 years and older with solid tumors with pathogenic inactivating alterations in TSC1 and TSC2 genes. The FDA granted Aadi Fast Track designation to evaluate nab-sirolimus for this patient population. Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. Neil Desai, Ph.D., Founder, Chief Executive Officer, and President of Aadi, stated “Following the approval and commercial launch of FYARRO™ (also known as nab-sirolimus) in advanced malignant PEComa, and initial demonstration of single agent activity outside of PEComa in patients with inactivating alterations in TSC1 or TSC2, we are now pursuing a tumor-agnostic indication for nab-sirolimus in patients with inactivating alterations in TSC1 or TSC2 following feedback on the study design from the U.S. Food and Drug Administration (FDA). These alterations are estimated to occur in over 10,000 advanced cancer patients per year, representing one of the larger targeted oncology opportunities.” Dr. Desai continued, “We believe the initiation of this registrational trial highlights our team’s ability to execute on drug development milestones and demonstrates meaningful progress towards expanding our nab-sirolimus program and establishing Aadi as a multi-indication, precision oncology company.” The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic registrational clinical trial of nab-sirolimus. Designed as a “basket trial”, the study will evaluate approximately 60 mTOR inhibitor naïve patients in each of two independent study arms (i.e., approximately 120 patients in total) comprised of patients with solid tumors harboring pathogenic inactivating alterations in either TSC1 or TSC2 genes. Preliminary data from PRECISION 1 are expected in the first half...