Aadi Bioscience to Present New Preclinical Data on nab-Sirolimus (ABI-009) at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

Rhea-AI Summary

Aadi Bioscience (AADI) will present a poster at the AACR-NCI-EORTC Virtual International Conference from October 7-10, showcasing preclinical data on nab-sirolimus (ABI-009) targeting PTEN and TSC2 deletions. The study suggests superior effectiveness of nab-sirolimus compared to sirolimus and everolimus. The company is focused on developing therapies for cancers with mTOR pathway alterations, with FYARRO receiving significant FDA designations and an upcoming New Drug Application review due by November 26, 2021.

Positive

• Successful preclinical data for nab-sirolimus in targeting PTEN and TSC2 deletions.
• FYARRO has received Breakthrough Therapy, Fast-Track, and Orphan Designations from the FDA.
• Upcoming PDUFA target action date for FYARRO's NDA is November 26, 2021.
• Plans for a tumor-agnostic registrational trial for mTOR inhibitor-naïve solid tumors by the end of 2021.

Negative

• Regulatory approval risks for FYARRO, including potential delays in commercialization.
• Uncertainties in clinical trial outcomes that could affect future results.

- Poster Presentation to go Live on October 7, 2021 at 9 a.m. ET and on Demand at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics -

LOS ANGELES, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced it will present a poster at the Virtual International Conference on Molecular Targets and Cancer Therapeutics to be held this year from October 7^th -10^th.

The Company will present preclinical data evaluating nab-sirolimus (ABI-009) in PTEN-deleted and TSC2-deleted cancer models in comparison with other mTOR inhibitors sirolimus and everolimus and evaluating their effects on important downstream targets S6 and 4EBP1.

Learn more about Aadi’s development of therapies that target the genetic drivers of cancers of the mTOR pathway at www.aadibio.com.

Aadi’s presentation at the 2021 AACR-NCI-EORTC International Conference:

All times noted are U.S. Eastern Time (ET).

Presentation Title: nab-Sirolimus improves mTOR pathway suppression and antitumor activity versus oral mTOR inhibitors in PTEN null bladder cancer (UMUC3) and TSC2 null liver cancer (SNU398) xenografts
Author: Shihe Hou, Ph.D., Aadi Bioscience, Inc.
Session: mTOR/PI3-kinase, P138
Session Date/Time: Thursday, October 7, 9:00 a.m. and on-demand throughout conference

The poster will be posted to the Events and Presentations section of Aadi Bioscience’s website after 9 am ET on October 7^th.

About Aadi Bioscience and FYARRO™

Aadi is a clinical-stage biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi’s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. Aadi’s lead product candidate is FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension; nab-sirolimus; ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models².

Aadi’s registration trial of FYARRO in advanced malignant PEComa (the “AMPECT trial”) demonstrated meaningful clinical efficacy in malignant PEComa¹, a type of cancer with the highest known alteration rate of TSC1 or TSC2 genes. FYARRO has received Breakthrough Therapy, Fast-Track and Orphan Designations from the U.S. Food and Drug Administration (FDA). A rolling New Drug Application (NDA) submission 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 Prescription Drug User Fee Act (“PDUFA”) target action date of November 26, 2021.

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

Forward-Looking Statements

Aadi Bioscience, Inc. (“Aadi”, “The Company”) cautions you that certain statements included in this press release that are not a description of historical facts 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 the clinical responses and safety profile, regulatory approval and commercialization, and the timing of the initiation of additional clinical trials. 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: risks related to Aadi’s ability to obtain, or the timeline to obtain, regulatory approval from the FDA and other regulatory authorities for FYARRO in advanced malignant PEComa; risks related to Aadi’s ability to successfully commercialize, including the timing of a commercial launch of FYARRO in advanced malignant PEComa; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi’s estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi’s operations, the biotechnology industry and the economy generally.

Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "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 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 caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

FYARRO™ is a trademark of Aadi Bioscience, Inc.

References:

¹ ASCO 2020 Abstract: https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.11516?af=R

² AACR 2019 Abstract: https://cancerres.aacrjournals.org/content/79/13_Supplement/348

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

Contacts

Investors:

Investors:
Irina Koffler
ikoffler@lifesciadvisors.com

FAQ

What is the purpose of Aadi Bioscience's poster presentation at the AACR-NCI-EORTC Conference?

The poster presentation aims to showcase preclinical data for nab-sirolimus (ABI-009) in cancer models with PTEN and TSC2 deletions.

When is the PDUFA target action date for FYARRO?

The PDUFA target action date for FYARRO's NDA review is November 26, 2021.

What designations has FYARRO received from the FDA?

FYARRO has received Breakthrough Therapy, Fast-Track, and Orphan Designations from the FDA.

What are the implications of the AMPECT trial for Aadi Bioscience?

The AMPECT trial demonstrated meaningful clinical efficacy for FYARRO in treating advanced malignant PEComa.

What is Aadi Bioscience planning after the AACR conference?

Aadi plans to initiate a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors with TSC1 or TSC2 alterations by the end of 2021.