On April 14, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported the presentation of three posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper), taking place April 14-19, 2023, in Orlando, FL (Press release, Aadi Bioscience, APR 14, 2023, View Source [SID1234630112]).

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The presentations at AACR (Free AACR Whitepaper) 2023 include: a trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial, a registrational directed tumor agnostic study for patients with solid tumors driven by TSC1 or TSC2 alterations; results on the anti-tumor activity of nab-sirolimus in combination with KRAS-G12C inhibitors in xenograft models; and results of a biomarker analysis from the AMPECT trial correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations, which includes previously reported response data from AMPECT.

Abstracts and poster presentation details are below:

Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with inactivating alterations in TSC1 or TSC2 (PRECISION I)"
Date and Time: Monday, April 17, 2023, 9:00 AM – 12:30 PM
Session Title: Phase II and Phase III Clinical Trials in Progress
Presentation Number: CT057

Abstract highlights:

nab-Sirolimus is a novel albumin-bound mTOR inhibitor (mTORi) approved in the US for adult patients with advanced malignant PEComa.
Eligible patients are ≥12 years old and mTORi-naïve, possess malignant solid tumors with TSC1 or TSC2 inactivating alterations (confirmed by central review of sequencing reports), and have received appropriate standard treatments, as determined by the investigator.
Available data from the AMPECT exploratory analysis and an expanded access program suggest acceptable efficacy and safety of nab-sirolimus, an mTORi with enhanced antitumor activity, in patients with solid tumors harboring inactivating alterations in TSC1 and/or TSC2.
nab-Sirolimus 100 mg/m2 will be given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progression-free survival by IRR, overall survival, patient-reported quality of life, and safety.
Enrollment began in March 2022. Collaboration with leading next-generation sequencing vendors will expedite the identification of patients with qualifying TSC1 or TSC2 mutations; study access will be facilitated through a "just-in-time" approach to trial location activation.
Based on the prevalence of TSC1 or TSC2 inactivating alterations, the most frequent tumor types expected are bladder, hepatobiliary, endometrial, soft tissue sarcoma, ovarian, and esophagogastric.
Title: "Synergistic anti-tumor activity of nab-sirolimus in combination with KRAS inhibitors (KRASis) sotorasib and adagrasib in KRAS G12C NSCLC and bladder cancer xenografts"
Date and Time: Tuesday, April 18, 2023, 1:30 – 5:00 PM
Session Category: Clinical Research Excluding Trials
Session Title: Combination Therapies for Cancer
Presentation Number: 5484

Abstract highlights:

KRAS is frequently mutated in non-small cell lung cancer (NSCLC) and other tumor types, with KRAS G12C mutation representing ~12% of patients with NSCLC. Sotorasib and adagrasib are approved for the treatment of KRAS­ G12C NSCLC. Mutations in KRAS may lead to mTORC1 activation, and mTOR may contribute to adaptive resistance to KRASis.
This study investigated the antitumor activity of nab-sirolimus in combination with KRASis in KRAS G12C NSCLC and bladder xenograft models.
nab-sirolimus in combination with either sotorasib or adagrasib showed greater tumor growth inhibition, a higher meaningful tumor regression rate and synergistic antitumor activity vs single agent therapy.
A multicenter, single-arm, open-label Phase 1/2 clinical study is planned to determine the recommended Phase 2 dose, safety, tolerability, and efficacy for the combination of adagrasib and nab-sirolimus in patients with KRAS G12C tumors.
Title: "Biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations"
Date and Time: Wednesday, April 19, 2023, 9:00 AM – 12:30 PM
Session Category: Clinical Research Excluding Trials
Session Title: Late-Breaking Research: Clinical Research 3
Presentation Number: LB288

Abstract Highlights:

An exploratory biomarker analysis was performed on samples from patients enrolled in the AMPECT study, a Phase 2, multicenter, open-label trial in advanced malignant PEComa (NCT02494570).
A variety of pathogenic inactivating alterations were observed in TSC1 and TSC2 genes, though TSC2 mutations were most commonly frameshift mutations; no recurring mutations were observed.
A tumor-agnostic study (PRECISION 1: NCT05103358) is now recruiting patients with pathogenic inactivating TSC1 or TSC2 alterations to further examine these biomarker findings.
Full session and meeting details are available through the AACR (Free AACR Whitepaper) Annual Meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2023 | Meetings | AACR (Free AACR Whitepaper). Each poster will be made available following the date of presentation at AACR (Free AACR Whitepaper), on the investor relations page of the Aadi website at www.aadibio.com