- Collaboration is Guardant Health’s first to explore both tissue- and blood-based assays as companion diagnostics (CDx)

Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, and AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, announced today a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360^® CDx and Guardant360 TissueNext™ assays as companion diagnostics for taletrectinib in the United States and European Union. Taletrectinib is an investigational ROS1 inhibitor for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

AnHeart received U.S. Food and Drug Administration Breakthrough Therapy Designation (BTD) for taletrectinib on August 1, 2022, for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 tyrosine kinase inhibitor treatment naïve or previously treated with crizotinib. BTD is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug has the potential to substantially improve clinical outcomes compared with available therapies. The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib.

"We are very excited to partner with Guardant Health, a global leader in oncology companion diagnostics, to identify NSCLC patients with ROS1 fusion mutations who may benefit from taletrectinib. There is a critical need to improve access to high quality diagnostics to help guide treatment decisions for patients,” said Junyuan (Jerry) Wang, Ph.D., chief executive officer of AnHeart Therapeutics. “With our BTD recently granted by FDA, we are committed to advancing taletrectinib for adult patients with advanced or metastatic NSCLC and improving access to convenient biomarker testing in patients who will benefit from our targeted therapy.”

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results from ctDNA in plasma to guide treatment in all solid tumors, including NSCLC. Guardant360 TissueNext provides oncologists with another option to obtain comprehensive genomic profiling results using tissue. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of genomic alterations associated with targeted treatments continues to grow.

“Our tissue- and blood-based assays play an essential role in the diagnosis of cancers by revealing actionable mutations that can help oncologists quickly match patients to the right targeted treatment,” said Helmy Eltoukhy, Guardant Health co-CEO. “We are proud to partner with AnHeart on this important endeavor to help identify lung cancer patients who may benefit from taletrectinib.”

About Taletrectinib

Taletrectinib is a novel potential best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers.

Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib.

Taletrectinib has received FDA Breakthrough Therapy Designation (BTD) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at https://clinicaltrials.gov. For questions about the ongoing trials, please contact trials@anhearttherapeutics.com.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360^®, Guardant360^® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI^® tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield^TM test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

About AnHeart Therapeutics

AnHeart Therapeutics (“AnHeart”) is a clinical-stage global biopharmaceutical company developing a broad pipeline of novel precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a potential best-in-class next-generation ROS1 inhibitor currently in Phase 2 trials for ROS1 TKI-naïve and TKI-pretreated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The Company’s pipeline also includes AB-218, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, please visit https://www.anhearttherapeutics.com/.

Guardant Health Forward-Looking Statement This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2021 and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

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