Aadi Bioscience announces the publication of its phase 2

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LOS ANGELES, October 22, 2021 (GLOBE NEWSWIRE) – Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a clinical-stage biopharmaceutical company specializing in precision therapies for genetically defined cancers with alterations in the mTOR pathway genes, today announced the publication of “to catch-Sirolimus for Patients with Malignant Perivascular Epithelioid Cell Tumors ”, detailing its AMPECT study of experimental ABI-009 in the American Society of Clinical Oncology’s Journal of Clinical Oncology. The authors concluded that the studies to catch-sirolimus (ABI-009, formerly known as to catch-rapamycin), if approved, may represent an important new treatment option in malignant PEComa, a rare cancer and an aggressive form of sarcoma, for which no treatment is currently approved.

The content of the publication included the primary analysis, which took place 6 months after the last patient in the AMPECT study began treatment, as well as a 1.5 year follow-up after the primary analysis with a date data cutoff November 23, 2020. In the trial, 34 patients were treated with ABI-009. In the 31 evaluable patients, the independently assessed overall response rate was 39% (12 of 31; with 95% confidence interval, 22% to 58%) with 1 complete response and 11 partial responses. In addition, 52% (16 of 31) of patients had stable disease. Responses were durable and the median duration of response was not reached after a median follow-up of response of 2.5 years, and 7 of 12 responders with ongoing treatment (range 5.6 to 47.2 month). Responses were rapid onset (67% at week 6). The safety profile was found to be acceptable with most treatment-related adverse events characterized as low grade and manageable for long-term treatment.

Andrew Wagner, MD, Ph.D., principal oncologist at the Dana-Farber Cancer Institute and principal investigator of the study, said: “We are delighted to publish the data obtained from this trial. to catch-Sirolimus provided very durable responses in patients with advanced PEComa. Most responder patients achieved a rapid response on their first assessment 6 weeks after initiation of treatment and these patients continued treatment for extended periods of time with an acceptable safety profile. We are encouraged by the results of this very first prospective clinical trial in patients with this extremely rare disease ”.

Neil Desai, Ph.D., co-author of the article and Founder, CEO and President of Aadi Bioscience, said, “The Aadi Bioscience team is extremely grateful to the patients, families and teams. clinical trials that help extend the limits of available care through their participation in clinical trials. The publication of these results is an important step not only for patients with malignant PEComa but also for the ongoing development of to catch-sirolimus throughout the investigation foreseen in TSC1 and TSC2 indications and other combination strategies.

A new drug application for investigational ABI-009 is under review by the United States Food and Drug Administration for the treatment of patients with PEComa and has a target date of action for user fees prescription drug from November 26, 2021. If approved, ABI-009 will be known. like FYARRO.

About Aadi Bioscience and FYARRO ™

Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically defined cancers. Aadi’s main goal is to provide transformational therapies to cancer patients with alterations in the motor of the mTOR pathway such as alterations in TSC1 Where TSC2 genes, where other mTOR inhibitors do not or cannot be exploited effectively due to problems of pharmacology, efficient drug delivery, safety or efficient targeting to the disease site. Aadi’s flagship product candidate is FYARROMT (nanoparticles bound to sirolimus albumin for suspension for injection; to catch-sirolimus; ABI-009), a human albumin-bound mTOR inhibitor that has demonstrated significantly higher tumor accumulation, greater suppression of the mTOR target, and increased tumor growth inhibition compared to other mTOR inhibitors in preclinical models1.

Aadi’s Registration Trial on FYARRO in Advanced Malignant PEComa (the “AMPECT Trial”) Demonstrated Significant Clinical Efficacy in Malignant PEComa2, a type of cancer with the highest known rate of damage to TSC1 Where TSC2 Genoa. FYARRO has received Breakthrough Therapy, Fast-Track, and Orphan designations from the United States Food and Drug Administration (FDA). A Continuing Drug Application (NDA) was completed in May 2021 for this indication and the FDA accepted the NDA in July 2021 and granted Aadi priority review status with a target action date under the Prescription Drug User Fee Act (“PDUFA”) of November 26. , 2021.

Based on the AMPECT trial and emerging data for FYARRO in other solid tumors with TSC1 Where TSC2 deactivation of alterations3, and following discussions with the FDA, Aadi plans to initiate a tumor-agnostic registration trial in mTOR inhibitor-naive solid tumors harboring TSC1 Where TSC2 inactivation of the alterations by the end of 2021. Aadi also has ongoing studies to evaluate the dosage of FYARRO in combination treatment regimens. FYARRO is an investigational drug that has not been approved by the FDA for commercial distribution in the United States. Further information is available on Aadi’s website at www.aadibio.com.

Forward-looking statements

Aadi Bioscience, Inc. (“Aadi”, “The Company”) warns you that certain statements included in this press release that are not a description of historical fact are forward-looking statements. These statements are based on Aadi’s current beliefs and expectations. Forward-looking statements include statements regarding: FYARRO, including expectations regarding clinical responses and safety profile, regulatory approval and marketing, and the timing of the initiation of additional clinical trials. Actual results could differ materially from those anticipated in these forward-looking statements due to these risks and uncertainties, which include, but are not limited to: risks relating to Aadi’s ability to obtain, or the timing to obtain, the regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi’s ability to market successfully, including the timing of the commercial launch of FYARRO in the advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the initiation, recruitment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and may not necessarily predict final outcomes; the risk that one or more of the clinical outcomes may change significantly as patient recruitment continues, as a result of more comprehensive data reviews, and as more patient data becomes available; the risk that unwanted effects or unforeseen side effects may occur during the development and testing of FYARRO; risks associated with the inability to realize any value from FYARRO in light of the risks and difficulties inherent in successfully bringing product candidates to market; risks associated with Aadi’s estimates of future expenses, capital requirements and the need for additional financing; and the risks associated with the impact of the COVID-19 epidemic on Aadi’s operations, the biotech industry and the economy in general.

Additional risks and uncertainties that could cause actual results to differ materially from those contemplated by forward-looking statements are included under “Risk Factors” 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 contained in this press release are only current as of the date hereof and, except as required by applicable law, Aadi does not undertake to revise or update any forward-looking statement, or to make any other forward-looking statement, 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 warning is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

FYARRO ™ is a trademark of Aadi Bioscience, Inc.

The references:

1 AACR-NCI-EORTC Molecular Targets and Cancer Therapy 2021 Summary: https://aadibio.com/wp-content/uploads/2021/10/ABI-009-Poster-091321-Final-Oral.pdf

2 ASCO 2020 summary: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

3 ASCO 2021 summary: https://meetings.asco.org/abstracts-presentations/197602

Contacts

Investors:

Irina Koffler
LifeSci Advisors LLC
[email protected]


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