UPDATE – Aadi Bioscience Presents Two Abstracts on FYARRO (nab-Sirolimus) at the Annual Meeting of the Connective Tissue Oncology Society (CTOS)
- In an Expanded Access Program, advanced malignant PEComa patients
whopreviously progressed on other mTOR inhibitors showed a 25% partial response rate and 63% clinical benefit rate when treated with nab-sirolimus; the subset of patients with TSC1 or TSC2 alterations showed a 44% response rate
- In a final analysis from the AMPECT registrational trial in mTOR naïve patients with advanced malignant PEComa, results of a 2.5 year-follow-up showed a median duration of response exceeding 36 months and conversion of 2 patients to complete responses
- FYARRO™ has a
November 26, 2021PDUFA target date
Abstract (ID: 1080984), lead-authored by
A second abstract (ID: 1080747), lead-authored by
About Malignant PEComa
Perivascular epithelioid-cell tumors (PEComa), defined by the
Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi’s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi’s lead product candidate is FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models.
Aadi’s registration trial of FYARRO in advanced malignant PEComa (the “AMPECT trial”) demonstrated meaningful clinical efficacy in malignant PEComa, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the
Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 or TSC2 inactivating alterations, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations by the end of 2021 or early 2022. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Aadi’s reports and other documents that Aadi has filed, or will file, with the
All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
FYARRO™ is a trademark of Aadi Bioscience, Inc.
Source: Aadi Bioscience