Two new real-world next-generation sequencing
studies reinforce prevalence of TSC1/2 mutations in up to 2% of all
tumors, a significant addressable cancer population
PRECISION1 tumor-agnostic trial testing
nab-sirolimus for patients with TSC 1/2 mutations on track for
interim analysis on 40 patients before the end of 2023
Evaluation of nab-sirolimus in preclinical
combination with PI3K and AKT inhibitors indicate enhanced
antitumor effects in PIK3CA-mutated breast cancer
LOS
ANGELES, Oct. 12, 2023 /PRNewswire/ -- Aadi
Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company
focused on developing and commercializing precision therapies for
patients with mTOR pathway alterations, today announced details of
four poster presentations at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics, taking
place October 11-15, 2023, in Boston, MA.
Abstracts and poster presentation details are below:
Title: "Inactivating TSC1 and TSC2 alterations,
co-mutations, and genomic instability in advanced cancers: Analysis
of a real-world (RW) patient population using the Foundation
Medicine genomic database"
Poster Number: C019
Session Title: Poster Session C
Date/Time: Saturday, October 14, 2023, 12:30
pm-4:00 pm EDT
Authors: David J. Kwiatkowski, MD, PhD; Norma A.
Palma, PhD; Willis H. Navarro, MD; Gopa Iyer, MD
Abstract highlights:
- To appreciate the potential for TSC1 and
TSC2 as therapeutic biomarkers, TSC1 and
TSC2 mutational data from an RW genomic database were
analyzed.
- Next-generation sequencing data from Foundation Medicine's
genomic database of patients primarily with advanced cancer were
analyzed using the FoundationInsights™ web-based
platform.
- In a large RW database of patients with advanced cancer,
inactivating TSC1 and TSC2 variants occurred in 1.9%
of patients. These occurred across common tumor types at rates as
high as 8.6% (urinary bladder tumors).
- These observations suggest cancers with TSC1 and/or
TSC2 alterations may be candidates for targeted
therapy.
Title: "Real-world (RW) characterization and frequency
of TSC1 and/or TSC2 alterations collected from tumor tissue and
liquid biopsies from the Tempus genomic database
in patients with advanced cancer" Poster
Number: B003
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30
pm-4:00 pm EDT
Authors: David J. Kwiatkowski, MD, PhD; Norma A.
Palma, PhD; Willis H. Navarro, MD; Gopa Iyer, MD
Abstract highlights:
- PRECISION1 will assess the clinical benefit
of nab-sirolimus in patients with cancer with
inactivating TSC1 or TSC2 alterations.
- To appreciate the potential for TSC1 and/or
TSC2 targeted therapy, TSC1 and TSC2
alterations across a large RW patient population with advanced
cancer using data from tissue and liquid biopsies were
analyzed.
- In a large (N=154,965) NGS database of patients with cancer,
inactivating TSC1 and/or TSC2 variants occurred in
about 1.7% of patients overall and were frequently identified in
commonly occurring cancers.
- The frequency of TSC1 and/or TSC2
alterations and tumor types were generally consistent between tumor
tissue samples and liquid biopsies.
- Consistency between primary vs metastatic samples
suggests TSC1 and TSC2 alterations may not be
acquired, although samples were not longitudinal.
Title: "Evaluation of nab-sirolimus in combination with
PI3K pathway inhibitors to overcome PI3K/mTOR resistance in
PI3K-mutant breast cancer cell lines" Poster
Number: A117
Session Title: Poster Session A
Date/Time: Thursday, October 12, 2023, 12:30
pm-4:00 pm EDT
Authors: Sean Wallace, PhD; Khine Nyein Myint,
PhD; Shihe Hou, PhD; Maria Zalath, BA; Andrew Kwon,
PhD; Brian McMorran, PhD; Igor Vivanco, PhD
Abstract highlights:
- The PI3K-AKT-mTOR pathway is frequently activated in many
cancer types and plays a central role in tumorigenesis.
However, clinical use of therapies targeting this pathway is
limited by compensatory vertical and horizontal feedback activation
loops, which limit antitumor efficacy and lead to drug
resistance.
- Combination therapy strategies employing simultaneous
inhibition of multiple PI3K-AKT-mTOR pathway elements may overcome
these resistance mechanisms and improve antitumor activity. In
these studies, we analyzed the effects of nab-sirolimus
combinations in PI3K-mutant breast cancer (BrCa) cells.
- The antitumor effects of PI3K and AKT inhibitors were
enhanced by the addition of the novel mTOR inhibitor
nab-sirolimus. The improved effectiveness of the PI3K and
mTOR inhibitor combination was due to the reciprocal overcoming of
resistance mechanisms induced by single agent treatment.
- These data potentially support a vertical PI3K pathway
inhibition strategy using nab-sirolimus and PI3K/AKT
inhibitors in PIK3CA-mutated BrCa, regardless of hormone receptor
status.
An encore presentation titled, "Phase 2, Multicenter,
Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors
Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2
(PRECISION1)" will also be presented during the late breaking
session on Friday, October 13, 2023.
More information can be found on the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics meeting website.
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 and has
commercialized FYARRO® for the treatment of adult
patients with locally advanced unresectable or metastatic malignant
perivascular epithelioid cell tumor (PEComa).
Aadi has also initiated PRECISION1, 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 are based on the Company's
current beliefs and expectations and may include, but are not
limited to, statements regarding: the Company's anticipated growth
and continued advancements, including in potential additional
indications; expectations regarding the beneficial characteristics,
safety, efficacy and therapeutic effects of FYARRO; expectations
regarding the size of the potential targeted markets for FYARRO,
including the market for patients harboring TSC1/TSC2
inactivating alterations; and the clinical results and timing of
additional clinical trials, including the registration-directed
PRECISION1 trial in patients harboring TSC1/TSC2
inactivating alterations and the release of data with respect
thereto. 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,
uncertainties associated with the clinical development and
regulatory approval of FYARRO 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 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; 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, 2022, including under the caption
"Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports
on Form 10-Q, 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