Aadi Bioscience to Present New Non-clinical Data Highlighting Combinability of nab-Sirolimus at the American Association for Cancer Research (AACR) Annual Meeting
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The recent findings from Aadi Bioscience regarding nab-sirolimus, particularly its combinability and potential synergy with endocrine therapy and PI3K pathway inhibitors, represent a significant stride in precision oncology. The data suggesting that nab-sirolimus can enhance the cytotoxic effects of fulvestrant and overcome resistance in hormone receptor-positive (HR+) breast cancer cells may have profound implications for treatment protocols. Resistance to therapies is a major hurdle in oncology and agents that can potentiate existing treatments or circumvent resistance mechanisms are highly valuable.
Moreover, the observed correlation between higher intratumoral drug concentration of nab-sirolimus and improved tumor suppression in non-small cell lung cancer (NSCLC) models when used in conjunction with KRAS G12C inhibitors provides a promising avenue for targeted therapy in NSCLC patients. The KRAS G12C mutation is a common oncogenic driver in NSCLC and the development of effective combination therapies is important for improving patient outcomes. The ability to achieve higher drug concentrations within tumors can directly translate to more effective disease control.
These developments could potentially lead to increased demand for nab-sirolimus as part of combination therapies, which in turn may impact Aadi Bioscience's market position and valuation. Investors should monitor the progress of the ongoing Phase 2 trial for further indications of the drug's efficacy and market potential.
From a market perspective, Aadi Bioscience's announcement could stimulate interest among investors and stakeholders in the precision oncology sector. The company's focus on cancers with alterations in the mTOR pathway positions it within a niche yet growing segment of the cancer treatment market. The mTOR pathway is implicated in various cancers and targeting it is a strategy that can lead to more personalized and effective treatments.
The potential for nab-sirolimus to be used in combination therapies opens up multiple avenues for commercial partnerships and licensing deals, which are common practices in the pharmaceutical industry to maximize drug reach and profitability. Additionally, the ability to overcome drug resistance is a key differentiator in the crowded oncology market and drugs that demonstrate this capability often command premium pricing and reimbursement rates.
Investors should consider the competitive landscape, as well as the regulatory and reimbursement challenges that Aadi Bioscience may face. The company's stock could be influenced by the outcomes of the Phase 2 trials and subsequent steps towards commercialization, such as regulatory approval and market access strategies.
The progression of nab-sirolimus into a Phase 2 trial for endometrioid-type endometrial cancer underscores the importance of clinical research in validating the efficacy of new drug combinations. The data presented at the AACR Annual Meeting serve as a precursor to more definitive clinical outcomes that will determine the drug's future. It is important to understand that while preclinical data are promising, the true test lies in clinical trial results, which evaluate not only efficacy but also safety and tolerability in patients.
Investors should be aware that the clinical trial landscape is highly complex and subject to regulatory scrutiny. The success of the Phase 2 trial could lead to further studies and eventual FDA approval, which would be a major catalyst for the company's stock. However, any setbacks in the trial could have the opposite effect. Therefore, monitoring the progress and results of these trials is essential for stakeholders to accurately gauge the potential impact on Aadi Bioscience's business.
Data further support clinical exploration of nab-sirolimus in combination with endocrine therapy for hormone-driven cancers, as is currently being investigated for patients with endometrioid-type endometrial cancer in a Phase 2 trial
Data highlight potential for synergy to enhance anti-cancer effects and overcome resistance in non-small cell lung cancer
Poster presentation details and abstract highlights include:
Title: "Evaluation of nab-sirolimus in combination with fulvestrant or PI3K pathway inhibitors to overcome resistance in breast cancer cell lines"
Presenting Author: Shihe Hou, PhD
Session Title: Reversal of Drug Resistance
Poster Number: Poster Section 25; Poster 6
Date/Time: Wednesday, April 10, 2024, 9:00 AM – 12:30 PM
- Fulvestrant, the selective estrogen receptor degrader and PI3K inhibitors, such as alpelisib, have demonstrated efficacy in patients with HR+ PI3K-mutated breast cancer; however, resistance still occurs
- nab-sirolimus enhanced the cytotoxic effects of fulvestrant in HR+ breast cancer cells and PI3Ki in both HR+ and HR- breast cancer cells
- The addition of nab-sirolimus to endocrine therapy or PI3K-AKT-mTOR pathway inhibitors may mutually overcome mechanisms of resistance induced by single-agent treatments
- These data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase 2 study (NCT05997017)
Title: "Correlation of nab-sirolimus tumor drug levels and improved tumor suppression in KRAS G12C non-small cell lung cancer xenografts treated with nab-sirolimus in combination with KRAS inhibitors"
Presenting Author: Shihe Hou, PhD
Session Title: Targeting Kinase and ERK Pathways
Poster Number: Poster Section 46; Poster 3
Date/Time: Tuesday, April 9, 1:30 – 5:00 PM
- Corresponding with greater antitumor activity, nab-sirolimus was associated with higher intratumoral drug concentration and stronger mTOR target suppression than everolimus when the agents were combined with KRAS G12C inhibitors
- These findings suggest more efficient tumor-targeting with nab-sirolimus plus a KRAS G12C inhibitor may lead to improved target inhibition and improved clinical outcomes
About Aadi Bioscience
Aadi is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression. To unlock the full potential of mTOR inhibition, Aadi uniquely combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus. Aadi received FDA approval and commercializes FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Aadi is exploring nab-sirolimus in PRECISION1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi is also exploring nab-sirolimus in two single-indication Phase 2 trials for difficult-to-treat mTOR-driven cancers: neuroendocrine tumors (NETs), and advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole. 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 are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; expectations regarding the clinical responses and safety profile, regulatory approval and commercialization; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. 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 the uncertainties associated with the clinical development and regulatory approval of FYARRO in additional indications; the risk that non-clinical results may not be reproduced and do not necessarily predict clinical results; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing.
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 the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the caption "Item 1A. 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 cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
IR@aadibio.com
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SOURCE Aadi Bioscience
FAQ
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