Press Release

Poster presentation scheduled for October 27, 2022

LOS ANGELES, Oct. 12, 2022 /PRNewswire/ -- 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, today announced that preclinical combination data of KRAS inhibitors and nab-sirolimus will be presented during a poster session at the upcoming 34^th EORTC-NCI-AACR Symposium, taking place October 26-28, 2022 in Barcelona, Spain. Nab-sirolimus is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

KRAS is frequently mutated in non-small cell lung cancer (NSCLC) and other tumor types, with the KRAS G12C present in approximately 9% of NSCLC patients. The mTOR pathway is often activated in patients with the KRAS mutation and contributes to adaptive resistance to KRAS inhibitors. Aadi scientists conducted studies to determine the utility of a combination of the mTOR inhibitor nab-sirolimus and KRAS inhibitors, which could have synergistic potential in the treatment of KRAS mutated cancers.

Sotorasib (AMG510) is approved for the treatment of KRAS G12C-mutated locally advanced or metastatic NSCLC, and adagrasib (MRTX 849) is under review for the treatment of KRAS G12C-mutated NSCLC. This study investigated the antitumor activity of mTOR inhibitors nab-sirolimus or everolimus in combination with sotorasib or adagrasib in KRAS G12C-mutated cancer xenografts.

Results of these studies showed that combining nab-sirolimus with either of the KRAS G12C inhibitors significantly improved response against KRAS G12C mutant lung cancer and bladder cancer tumors in vivo and nab-sirolimus also showed significantly greater potency in the combination compared to everolimus. The nab-sirolimus combinations with sotorasib and adagrasib will be detailed in the upcoming poster.

"Increase in mTOR signaling can cause resistance to KRAS G12C inhibitors. Combination strategies that act through disease-driving pathways, like mTOR and KRAS, are critical to mitigating resistance and providing clinical benefit," said Neil Desai, Ph.D., Founder and Chief Executive Officer of Aadi Bioscience. "These preclinical results demonstrate that nab-sirolimus has the potential to be the preferred mTOR inhibitor in combination with the KRAS inhibitors and we look forward to exploring this approach in the clinic."

The details of the poster presentation are below:

Title: "KRAS G12C mutated NSCLC and bladder cancer xenografts treated with sotorasib and adagrasib in combination with mTOR inhibitors show improved antitumor activity of nab-sirolimus vs everolimus"
Abstract Number: 163
Session Title/Code: Combination Therapies/PP08
Date/Time: Thursday, October 27, 2022, 10am – 5pm
Authors: Shihe Hou, PhD, Jorge Nieva, MD, and Neil Desai, PhD

Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically defined cancers to bring transformational therapies to cancer patients with mTOR pathway driver alterations. Aadi received FDA approval in November of 2021 and in February of 2022 commercialized FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Aadi has also initiated PRECISION 1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. More information on the Company's development pipeline is available on the Aadi website at www.aadibio.com and connect with us on Twitter and LinkedIn.

This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding Aadi's current beliefs and expectations; expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of nab-sirolimus; plans related to further development of nab-sirolimus; the clinical results and timing of additional clinical trials; and the timing and likelihood of regulatory filings and approvals of nab-sirolimus, including in potential additional indications and potential filings in additional jurisdictions. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, those associated with uncertainties associated with the clinical development and regulatory approval of nab-sirolimus in additional indications, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing nab-sirolimus; and risks related to collaborations with third-parties.

Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in Aadi's Quarterly Report on Form 10-Q filed on August 10, 2022, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.

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 cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
Marcy Graham
IR@aadibio.com 

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SOURCE Aadi Bioscience