RedCloud Bio (the “Company”), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug discovery and development, announced completion of the first patient dosing for its next-generation EGFR TKI H002 in its H002-101CN study. The study is a multicenter phase I/IIa clinical trial in China for advanced NSCLC. H002 is a next-generation EGFR TKI discovered and developed by RedCloud Bio for treatment of prior EGFR TKI-resistant NSCLC, including those with C797S mutation.
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“Dosing of this first patient is an important clinical and scientific milestone in RedCloud Bio’s new drug development journey,” said Dr. Mai-Jing Liao, CEO of RedCloud Bio. “Increasing use of third-generation EGFR TKI in both first-line and second-line EGFR mutation-positive NSCLC patients has been associated with a rise in resistance to third-generation EGFR TKI drugs – and is now a major unmet medical need for patients around the globe. Dr. Liao noted: “H002 has demonstrated in preclinical studies both strong and broad-spectrum activities against multiple EGFR mutation combinations, and high selectivity and safety profile. The drug candidate has great potential to treat prior EGFR-TKI resistant lung cancer patients, including those with brain metastases. RedCloud Bio is looking forward to bringing a much-needed precision medicine to advanced NSCLC patients worldwide.”
The H002-101CN Phase I/IIa clinical study consists of two parts: a dose-escalation component to assess the safety, tolerability, maximum tolerated dose, optimal biological effect dose or recommended phase II dose, pharmacokinetic parameters and preliminary antitumor activity of H002 monotherapy. A second segment includes dose expansion to assess antitumor activity, safety and pharmacokinetic parameters of H002 monotherapy at selected doses for NSCLC patients with defined mutations. This study will also monitor and evaluate multiple biomarkers to provide guidance for subsequent clinical trial design.
H002 is a fourth generation EGRF inhibitor discovered and developed by RedCloud Bio. In preclinical studies, the candidate has exhibited broad-spectrum potency and high selectivity against multiple EGFR mutations, including single point mutations (Del19 and L858R), double mutations (Del19/C797S, L858R/C797S, Del19/T790M and L858R/T790M); and triple mutations (Del19/T790M/C797S and L858R/T790M/ C797S). These studies also demonstrated that H0002 has durable antitumor activity and a desirable safety profile. H002 has shown potent anti-tumor activities in an EGFR-positive brain metastases model.