H002 is a precision therapeutic candidate for the treatment of NSCLC, with broad spectrum and high selectivity against multiple EGFR mutations including those with EGFR C797S mutation. RedCloud Bio has initiated H002 Phase I/IIa clinical studies in both China and US.

SHANGHAI, Aug. 29, 2022 /PRNewswire/ — 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. 

“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.”

Study Design

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.

About H002

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.

Phase I/IIa clinical studies for H002 in advanced NSCLC have been initiated in both US and China. RedCloud Bio plans to globally develop H002 as a next-generation EGFR kinase inhibitor to address the high unmet clinical needs for EGFR TKI resistant NSCLC.

About RedCloud Bio

RedCloud Bio is an innovative biotech company integrating structural pharmacology and computing technologies to advance small molecule drug discovery and development, with global clinical development capabilities. The Company has laboratories in Shanghai and Beijing.

RedCloud Bio has accumulated structural data and algorithm models covering clinically important targets, and has built an innovative pipeline targeting tumor resistance and critical diseases with high unmet medical needs. The Company’s lead therapeutic candidate, H002, is a small molecule compound targeting multiple EGFR TKI resistance mutations. The compound, now in global clinical trials, is a promising candidate as a next-generation TKI with unique clinical differentiation for NSCLC.

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