Mirati Therapeutics and Aadi Bioscience Partner to Evaluate the Combination of Adagrasib with Nab-sirolimus in Patients with Advanced Non-Small Cell Lung Cancer and Other Solid Tumors with a KRAS[G12C] Mutation
The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial is to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and nab-sirolimus in patients with KRASG12C - mutant solid tumors. In addition, the study will investigate the safety, tolerability and efficacy of adagrasib and nab-sirolimus in combination in patients both with and without prior exposure to a KRASG12C inhibitor. The trial will build on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and nab-sirolimus relative to either agent alone.
"We are pleased to collaborate with Aadi on this clinical study of adagrasib and nab-sirolimus. Our collaborative preclinical work has demonstrated that combinatorial mTOR and KRAS inhibition addresses key bypass and feedback pathways associated with either drug target and also results in enhanced efficacy in tumor models harboring KRASG12C mutations. We believe the data from this trial may improve patient outcomes," said
"KRAS and mTOR are closely linked and key pathways in oncogenesis and resistance to treatment. This collaboration builds on strong preclinical and mechanistic rationale supporting the combination of the two drugs to potentially provide greater benefit for patients with KRASG12C mutant NSCLC and other cancers," said Neil Desai, Ph.D., founder, president and chief executive officer,
Under the terms of the collaboration agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study, and jointly with Aadi, will oversee and share the cost of the study.
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life, extensive tissue distribution and is well tolerated. Adagrasib has also shown, in clinical trials, CNS penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors with KRASG12C mutations. Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies with strong scientific rationale in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.
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
For more information about
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.
This press release contains forward-looking statements regarding the business of
Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati's programs are described in additional detail in Mirati's quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the
This press release contains certain forward-looking statements regarding the business of
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
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.
Aadi Contact
Investor Relations: ir@aadibio.com
Mirati Contacts
Investor Relations: ir@mirati.com
Media Relations: media@mirati.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/mirati-therapeutics-and-aadi-bioscience-partner-to-evaluate-the-combination-of-adagrasib-with-nab-sirolimus-in-patients-with-advanced-non-small-cell-lung-cancer-and-other-solid-tumors-with-a-krasg12c-mutation-301646795.html
SOURCE