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Racura Oncology Wins Governance Nod to Launch HARNESS-1 Lung Cancer Trial

Story Highlights
  • Racura Oncology gained governance approval to start its HARNESS-1 Phase 1 trial of RC220 with osimertinib in EGFR-mutated lung cancer patients.
  • The multi-centre study uses ctDNA-guided enrolment and adaptive dose-escalation to identify an optimal RC220 dose, aiming to combat resistance to EGFR inhibitors and bolster Racura’s oncology pipeline.
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Racura Oncology Wins Governance Nod to Launch HARNESS-1 Lung Cancer Trial

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The latest announcement is out from Race Oncology Ltd. ( (AU:RAC) ).

Racura Oncology has secured governance approval from Monash Health to commence its HARNESS-1 Phase 1 trial of RC220 in combination with AstraZeneca’s osimertinib in EGFR-mutated non-small cell lung cancer. The company positions RC220 as an RNA and DNA G4 binder designed to tackle key mechanisms of resistance to EGFR tyrosine kinase inhibitors, addressing a significant unmet need in this patient population.

Site initiation and training at Monash Medical Centre are scheduled for late March, with site activation enabling the first patient recruitment and up to four additional sites expected to follow. The multi-centre Phase 1a/b study uses circulating tumour DNA to screen patients, applies an accelerated and Bayesian dose-escalation design to determine the maximum tolerated dose, and then moves to a randomised dose-expansion stage to further assess safety, pharmacokinetics and early efficacy signals such as progression-free and overall survival.

By aligning its trial design with regulatory expectations such as the U.S. FDA’s Project Optimus, Racura aims to optimise dosing and improve the benefit-risk balance of RC220 combinations. Successful execution of HARNESS-1 could strengthen the company’s position in targeted lung cancer therapies and provide new treatment options for patients who are at risk of developing resistance to current EGFR inhibitors.

The most recent analyst rating on (AU:RAC) stock is a Hold with a A$2.50 price target. To see the full list of analyst forecasts on Race Oncology Ltd. stock, see the AU:RAC Stock Forecast page.

More about Race Oncology Ltd.

Racura Oncology Limited is an Australian clinical-stage biotechnology company focused on developing novel cancer therapeutics. Its lead asset RC220 (E,E-bisantrene) targets RNA and DNA G-quadruplex structures, with a current development emphasis on combination regimens in epidermal growth factor receptor-mutated non-small cell lung cancer patients receiving standard-of-care tyrosine kinase inhibitors.

Average Trading Volume: 161,373

Technical Sentiment Signal: Buy

Current Market Cap: A$394.4M

For detailed information about RAC stock, go to TipRanks’ Stock Analysis page.

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