Aadi Bioscience Announces Data Presentation on incidence of TSC1 and TSC2 Alterations in Advanced Cancers at the Annual Meeting of the American Association for Cancer Research (AACR)

The first rigorous analysis estimates the incidence of TSC1 and TSC2 fixed-effect changes in the US as approximately 12,000 advanced cancer patients in 2030.

– Findings also identify the highest frequency of TSC1 alterations in bladder, kidney and lung squamous cell cancers, whereas TSC2 alterations have the highest frequency in hepatobiliary, ovarian and soft tissue sarcomas.

LOS ANGELES, April 08, 2022 (Globe Newswire) — Aadi Bioscience, Inc. (“Adi”) (Nasdaq: AADI), is a biopharmaceutical company focused on the development and commercialization of precision therapies for genetically defined cancers with mutations in mTOR pathway genes. Today announced the presentation of a poster (#5799) at the American Association for Cancer Research (AACR) annual meeting to be held April 8-13, 2022 in New Orleans, LA. Research presented measures the type and number of advanced cancer patients with malignant tumors TSC1 either TSC2 Change

Gunsagar S. The study presented by Gulati, MD, PhD, resident physician at Brigham and Women’s Hospital (BWH) in Boston, evaluated which scenario TSC1 either TSC2 Transformation in 31 solid tumors from The Cancer Genome Atlas (TCGA); n ~10,000 patients), AACR Genie Database (Memorial Sloan Kettering (MSK): n ~15,000 patients, and the Dana Farber Cancer Institute (DFCI): n ~5,500 patients) and subsequently estimated the annual incidence of patients with these changes using the Surveillance, Epidemiology, and End Results Program (SEER) database.

The study, which was conducted by additional researchers from BWH, the University of Texas MD Anderson Cancer Center, and Tesselon in Missouri, found that the incidence of advanced cancer patients TSC1 either TSC2 Alterations in the US are projected to be about 32,000 in 2030, of whom about 12,000 patients have “fixed” mutations (frameshift, nonsense, splice-site mutations and deep deletions). TSC1 The changes were most frequent in squamous cell cancers of the bladder, kidney, and lung, whereas TSC2 Changes were most frequent in hepatobiliary, ovarian and soft tissue sarcomas.

Neil Desai, PhD, Founder, CEO and President of Aadi said, “In line with our expectations, the incidence of patients TSC1 either TSC2 Fixed effect mutation is important, and more than just the incidence of actionable mutation. EGFR, KRAS, HER2, PIK3CAeither braf, We are actively enrolling patients in our ongoing critical Precise 1 trial to evaluate NAB-In patients harboring sirolimus TSC1 either TSC2 mutations and look forward to reporting preliminary data in the first half of next year.”

About Aadi Bioscience

Aadi is a biopharmaceutical company focused on precision treatments for genetically defined cancers. ADI’s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations, where other mTOR inhibitors cannot be exploited effectively due to problems with pharmacology, effective drug delivery, safety, or effective targeting at the disease site. is or cannot be done. In November 2021, Aadi received FDA approval for FYARRO™ to treat adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and in February 2022 Aadi launched the commercial launch of FYARRO in this indication. announced. FYARRO is an mTOR inhibitor bound to human albumin that has demonstrated significantly greater tumor accumulation, greater mTOR target suppression, and tumor growth inhibition than other mTOR inhibitors in preclinical models.

Based on data from the AMPECT trial with FYARRO and following discussions with the FDA regarding other emerging data with FYARRO, Adi has initiated a tumor-agnostic registration trial harboring mTOR inhibitor-naive solid tumors. TSC1 either TSC2 passive change. Aadi also has ongoing studies evaluating FYARRO supplements in a combination regimen. More information about Aadi’s development pipeline is available on the Aadi website at www.aadibio.com.

forward-looking statements

Warns you that certain statements contained in this press release that are not statements of historical facts are forward-looking statements. These statements are based on Adi’s current beliefs and expectations. Forward-looking statements include statements regarding the following: our plans and prospects for success relating to FYARRO’s commercialization; expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; Our plans for further development and construction of FYARRO; Timing of additional clinical trials, including registration trials in asylum-stricken patients TSC1 And TSC2 passive change; the timing or likelihood of regulatory filings and FYARRO approval, including potential additional indications and potential filings in additional jurisdictions; FYARRO’s anticipated reception in the physician community; and the adequacy of our existing capital resources and the expected time frame to meet our future operating expenditure and capital expenditure requirements. Actual results may differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including without limitation: risks related to the ability of FYARRO to successfully commercialize etc.; uncertainties associated with clinical development and regulatory approval of FYARRO in additional indications, including potential delays in initiation, enrollment and completion of clinical trials for additional indications; the risk that unexpected adverse reactions or side effects may occur during the commercialization, development and testing of FYARRO; the risks associated with failure to realize any value from FYARRO in light of the risks and difficulties inherent in successfully bringing product candidates to market; Risks relating to estimates of future expenses, capital requirements and need for additional financing, etc.; and risks related to the impact of the COVID-19 pandemic on Aadi’s operations, the biotechnology industry and the economy in general.

Additional risks and uncertainties that could cause actual results and results to differ materially from those contemplated by the forward-looking statements shall be addressed under the heading “Risk Factors” in Form 10-K of ETC filed on March 17, 2022 have been included, and are included in reports elsewhere etc. and other documents that Adi has filed, or will file, with the SEC from time to time and will be available at www.sec.gov.

All forward-looking statements in this press release are current only as of the date herein and, except as required by applicable law, do not undertake any obligation to modify or update any forward-looking statements, etc., or to make any other forward-looking statements. , whether as a result of new information, future events or otherwise. All forward-looking statements are fully qualified by this warning statement. This precaution has been taken under the Safe Harbor provisions of the Private Securities Litigation Reform Act 1995.

FYARRO™ Addicted Bioscience, Inc. is a trademark of.

For more information about FYARRO, visit: https://fyarro.com/


Irina Koffler
LifeScience Advisors LLC
[email protected]

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