Nab-sirolimus added to KRAS inhibitor
treatment demonstrated significantly greater antitumor activity and
tumor regressions compared to the KRAS inhibitors alone
The KRAS inhibitor combinations with
nab-sirolimus were significantly more active than the corresponding
everolimus combinations
LOS
ANGELES, Oct. 27, 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 preclinical
combination data of KRAS inhibitors and nab-sirolimus at the
34th EORTC-NCI-AACR Symposium. Nab-sirolimus is a
novel albumin-bound nanoparticle form of the mTOR inhibitor
sirolimus and is approved for the treatment of locally advanced
unresectable or metastatic malignant perivascular epithelioid cell
tumor (PEComa).
Sotorasib (AMG510) is approved for the treatment of
KRASG12C-mutated locally advanced or metastatic
non-small cell lung cancer (NSCLC), and adagrasib (MRTX 849) is
under review by the FDA for the treatment of
KRASG12C-mutated NSCLC. The mTOR pathway is often
activated in patients with the KRAS mutation and contributes to
adaptive resistance to KRAS inhibitors. This study investigated the
preclinical antitumor activity of mTOR inhibitors
nab-sirolimus or everolimus in combination with sotorasib or
adagrasib in KRASG12C-mutated cancer xenografts.
"We are excited to present these compelling combination data at
the EORTC-NCI-AACR Symposium, which laid the foundation for our
recent partnership with Mirati on combination strategies to treat
NSCLC and solid tumor cancers," said Neil Desai, Ph.D.,
Founder and Chief Executive Officer of Aadi Bioscience. "These
preclinical results demonstrate that nab-sirolimus has the
potential to significantly improve the antitumor activity of
adagrasib or sotorasib, two of the most promising KRAS inhibitors
today. We are actively collaborating to initiate an open label
Phase 1/2 study that will evaluate adagrasib and
nab-sirolimus in the clinic, with the goal of mitigating
resistance and improving clinical outcomes."
Results of these studies showed that combining
nab-sirolimus with either sotorasib and adagrasib showed
supra-additive or synergistic antitumor activity with significantly
greater tumor growth inhibition and meaningful tumor regressions
than the single agents. In contrast, everolimus in combination with
the KRAS inhibitors was not as effective. We believe that these
results strongly suggest that nab-sirolimus is the preferred
mTOR inhibitor for combination treatment and should be further
explored as a potential combination treatment option with adagrasib
or sotorasib in the clinic.
The details of the poster presentation are below:
Title: "KRAS G12C mutated NSCLC and bladder
cancer xenografts treated with sotorasib and adagrasib in
combination with mTOR inhibitors show improved antitumor activity
of nab-sirolimus vs everolimus"
Abstract Number: 163
Session Title/Code: Combination Therapies/PP08
Date/Time: Thursday, October 27,
2022, 10am – 5pm
Authors: Shihe Hou, PhD, Jorge
Nieva, MD, and Neil Desai,
PhD
About nab-sirolimus
Nab-sirolimus is a novel albumin-bound nanoparticle form
of the mTOR inhibitor sirolimus and is currently being evaluated in
a tumor-agnostic registration-directed trial in mTOR
inhibitor-naïve malignant solid tumors harboring TSC1 or
TSC2 inactivating alterations. In November 2021, nab-sirolimus was approved
by the U.S. Food and Drug Administration (FDA) as FYARRO® for the
treatment of adult patients with locally advanced unresectable or
metastatic malignant perivascular epithelioid cell tumor
(PEComa).
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 in November of 2021
and in February of 2022 commercialized FYARRO® for the treatment of
adult patients with locally advanced unresectable or metastatic
malignant perivascular epithelioid cell tumor (PEComa).
Aadi has also 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 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 include statements regarding Aadi's current beliefs and
expectations; expectations regarding the beneficial
characteristics, safety, efficacy and therapeutic effects of
nab-sirolimus; plans related to further development of
nab-sirolimus; the clinical results and timing of additional
clinical trials; and the timing and likelihood of regulatory
filings and approvals of nab-sirolimus, including in
potential additional indications and potential filings in
additional jurisdictions. 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 uncertainties associated with the
clinical development and regulatory approval of
nab-sirolimus 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 nab-sirolimus; and
risks related to collaborations with third-parties.
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 Aadi's Quarterly
Report on Form 10-Q filed on August 10,
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/aadi-bioscience-announces-improved-anti-tumor-activity-of-kras-inhibitors-in-combination-with-nab-sirolimus-at-the-34th-eortc-nci-aacr-symposium-301661189.html
SOURCE Aadi Bioscience