Trial-in-progress poster showcases clinical
trial design for PRECISION 1 and two additional posters demonstrate
favorable durability of response and long-term safety of
nab-sirolimus in the completed AMPECT study
LOS
ANGELES, Nov. 17, 2022 /PRNewswire/ -- Aadi
Bioscience, Inc. (NASDAQ: AADI), a commercial-stage
biopharmaceutical company focused on developing and commercializing
precision therapies for genetically-defined cancers with
alterations in mTOR pathway genes, today presented three posters on
completed and ongoing clinical trials for nab-sirolimus at
the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting,
taking place November 16-19, 2022 in
Vancouver, Canada.
nab-sirolimus (FYARRO®) is a novel mTOR inhibitor that
leverages albumin-bound nanoparticle technology and is approved for
the treatment of locally advanced unresectable or metastatic
malignant perivascular epithelioid cell tumor (PEComa).
"We are thrilled to share more information from our AMPECT and
PRECISION 1 trials with the leading sarcoma specialists from around
the globe at CTOS 2022," said Loretta Itri, M.D., Chief
Medical Officer of Aadi Bioscience. "The trial-in-progress
poster presents the design of our PRECISION 1 trial, while our two
additional posters provide long-term analysis from our AMPECT trial
that demonstrates nab-sirolimus' durability of response and
long-term safety. We want to thank the CTOS organizers for the
opportunity to showcase Aadi's clinical success and the patients
who participated in these studies."
Details of the poster presentations are below:
Title: "Phase 2, Multicenter, Open-Label Basket Trial
of nab-Sirolimus for Patients with Malignant Solid Tumors
Harboring Pathogenic Inactivating Alterations in TSC1 or
TSC2 Genes (PRECISION 1)"
Date/Time: Thursday, November 17,
2022
Aadi and its collaborators present a trial-in-progress poster
for PRECISION 1, a registrational-directed trial now recruiting for
patients with solid tumors driven by TSC1/TSC2 alterations,
an underserved patient population with no targeted therapeutic
options.
Title: "Study-end Analysis from AMPECT, an
Open-Label, Phase 2 Registration Trial of Patients with Advanced
Malignant PEComa Treated with nab-Sirolimus, Showing
Durability of Responses and Long-Term Safety"
Date/Time: Thursday, November 17,
2022
Aadi and its collaborators present final 3-year follow up data
from the AMPECT Phase 2 study. The AMPECT study met its primary
endpoint, showing a median Duration of Response (DoR) of over 3
years. In addition, median Overall Survival (OS) was updated to
53.1 months. Overall Response Rate (ORR), Disease Control Rate
(DCR), and Progression Free Survival (PFS) were consistent with
prior analysis of nab-sirolimus in AMPECT.
Title: "Management of Adverse Events in the
AMPECT Trial of nab-Sirolimus for the Treatment of Advanced
Malignant Perivascular Epithelioid Cell Neoplasm
(PEComa)
Date/Time: Thursday,
November 17, 2022
Aadi and its collaborators present data on the adverse event
(AE) management in the AMPECT trial over three years after the
primary analysis was presented. nab-Sirolimus was
generally well-tolerated, and the majority of the AEs due to
nab-sirolimus treatment in the AMPECT trial were manageable.
Importantly, dose reductions for AE management did not appear to
compromise efficacy in patients who responded to therapy.
More information can be found on the CTOS meeting website at
2022 CTOS Annual Meeting (eventscribe.net).
About Aadi Bioscience
Aadi is a commercial-stage biopharmaceutical company focused on
precision therapies for genetically defined cancers. Aadi's primary
goal is to bring transformational therapies to cancer patients with
mTOR pathway driver alterations 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. In November 2021, Aadi received
FDA approval for FYARRO® for the treatment of adult
patients with locally advanced unresectable or metastatic malignant
perivascular epithelioid cell tumor (PEComa), and in February
2022, Aadi announced the commercial launch of FYARRO in this
indication.
Based on exploratory data from AMPECT, a registrational study
supporting approval in advanced malignant PEComa, and following a
pre-IND meeting with the FDA, Aadi has initiated PRECISION 1, a
Phase 2 tumor-agnostic registration-intended trial in mTOR
inhibitor-naïve malignant solid tumors
harboring TSC1 or TSC2 inactivating
alterations. More information is available on the Aadi
Bioscience website at www.aadibio.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains certain forward-looking statements
regarding the business of Aadi Biosciences that are not a
description of historical facts within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding the Company's current
beliefs and expectations; the Company's anticipated growth; plans
and potential for success relating to commercializing FYARRO;
expectations regarding the beneficial characteristics, safety,
efficacy and therapeutic effects of FYARRO; expectations regarding
management's performance; plans related to further development and
manufacturing of FYARRO; pricing and reimbursement of FYARRO; the
rate and degree of market acceptance of FYARRO; anticipated
reception of FYARRO in the physician community; the clinical
results and timing of additional clinical trials, including the
registration-directed trial in patients
harboring TSC1 or TSC2 inactivating
alterations; the timing and likelihood of regulatory filings and
approvals of FYARRO, including in potential additional indications
and potential filings in additional jurisdictions; plans regarding
clinical trials, in collaboration with Mirati Therapeutics, for the
combination of adagrasib and nab-sirolimus in patients with
KRASG12C-mutant tumors and related timing and expectations
regarding the efficacy of the combination; and the sufficiency of
our existing capital resources and the expected timeframe to fund
our 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 ability to successfully commercialize FYARRO; risks
related to reimbursement and pricing of FYARRO; 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; 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 pandemic 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 in the Company's
Annual Report on Form 10-K for the fiscal year ended December
31, 2021, including under the caption "Item 1A. Risk Factors," and
in Aadi's subsequent Quarterly Reports on Form 10-Q filed
on May 12, 2022, August 10, 2022 and November
9, 2022, 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