Press Release

Nab-sirolimus added to KRAS inhibitor treatment demonstrated significantly greater antitumor activity and tumor regressions compared to the KRAS inhibitors alone

The KRAS inhibitor combinations with nab-sirolimus were significantly more active than the corresponding everolimus combinations

LOS ANGELES, Oct. 27, 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 presented preclinical combination data of KRAS inhibitors and nab-sirolimus at the 34^th EORTC-NCI-AACR Symposium. 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).

Sotorasib (AMG510) is approved for the treatment of KRAS^G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), and adagrasib (MRTX 849) is under review by the FDA for the treatment of KRAS^G12C-mutated NSCLC. The mTOR pathway is often activated in patients with the KRAS mutation and contributes to adaptive resistance to KRAS inhibitors. This study investigated the preclinical antitumor activity of mTOR inhibitors nab-sirolimus or everolimus in combination with sotorasib or adagrasib in KRAS^G12C-mutated cancer xenografts.

"We are excited to present these compelling combination data at the EORTC-NCI-AACR Symposium, which laid the foundation for our recent partnership with Mirati on combination strategies to treat NSCLC and solid tumor cancers," said Neil Desai, Ph.D., Founder and Chief Executive Officer of Aadi Bioscience. "These preclinical results demonstrate that nab-sirolimus has the potential to significantly improve the antitumor activity of adagrasib or sotorasib, two of the most promising KRAS inhibitors today. We are actively collaborating to initiate an open label Phase 1/2 study that will evaluate adagrasib and nab-sirolimus in the clinic, with the goal of mitigating resistance and improving clinical outcomes."

Results of these studies showed that combining nab-sirolimus with either sotorasib and adagrasib showed supra-additive or synergistic antitumor activity with significantly greater tumor growth inhibition and meaningful tumor regressions than the single agents. In contrast, everolimus in combination with the KRAS inhibitors was not as effective. We believe that these results strongly suggest that nab-sirolimus is the preferred mTOR inhibitor for combination treatment and should be further explored as a potential combination treatment option with adagrasib or sotorasib 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

About nab-sirolimus

Nab-sirolimus is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is currently being evaluated in a tumor-agnostic registration-directed trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. In November 2021, nab-sirolimus was approved by the U.S. Food and Drug Administration (FDA) as FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About Aadi Bioscience, Inc.

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.

Forward-Looking Statements

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