Hongyun Biotech Announces First Patient Dosed in Phase I/IIa Trial of H002, a Novel Fourth-Generation EGFR Inhibitor for NSCLC

- H002 is a fourth-generation treatment for advanced non-small cellLung CancerThePrecisionTherapeutic candidate drug, broad-spectrum and selective inhibition of various EGFR mutations, especially third-generation resistance mutations containing C797S

- RedCloudBio has initiated a Phase I/IIa clinical study in China and the United States for H002 targeting advanced non-small cell lung cancer resistant to EGFR TKI treatment.

2022YearAugust 29, Shanghai, China RedCloudBio Co., Ltd. (RedCloudBio), an innovative drug discovery company at the forefront of utilizing structural pharmacology and computational technologies to focus on the dynamic structures of protein and drug complexes, announced that the first patient has been dosed in the multicenter clinical Phase I/IIa study, H002-101CN, conducted in China for advanced non-small cell lung cancer (NSCLC). H002 is a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) independently developed by RedCloudBio, which can be used to treat various C797S mutation combination-driven NSCLC cases resistant to third-generation EGFR TKIs after first- or second-line treatment.

Dr. Liao Maijing, CEO of RedCloudBio, stated: "We are pleased to announce that the first subject has been dosed in the Phase I/IIa clinical trial of H002 for non-small cell lung cancer. H002 is the first innovative precision treatment candidate from RedCloudBio to enter the clinical stage, marking a significant milestone in our new drug development journey. As third-generation EGFR TKIs are increasingly used as first- and second-line treatments for patients with EGFR mutation-positive non-small cell lung cancer, resistance to these drugs has become a major unmet clinical need in global lung cancer treatment. Preclinical data show that H002 exhibits broad-spectrum inhibition of various EGFR mutations, along with high selectivity and safety, and has the potential to treat brain metastases in EGFR-positive lung cancer. We have now initiated clinical studies in both China and the United States, and we look forward to providing urgently needed precision treatment options for patients with advanced non-small cell lung cancer worldwide."

H002-101CN Phase I/IIa Clinical Study consists of two parts: a dose-escalation phase to evaluate the safety, tolerability, maximum tolerated dose (MTD), optimal biological effect dose (OBD) or recommended Phase II dose (RP2D), pharmacokinetic properties, and preliminary anti-tumor activity of H002 as a monotherapy; and a dose-expansion phase to assess the anti-tumor activity, safety, and pharmacokinetic properties of H002 as a monotherapy at the selected dose in patients with specific mutations. This study will dynamically detect and evaluate relevant biomarkers, analyze clinical data from multiple perspectives, and provide guidance for subsequent clinical trials.

About H002

H002 is a fourth-generation EGFR inhibitor independently developed by RedCloudBio. It demonstrates broad-spectrum and high selectivity against various EGFR mutations, showing extensive and sustained anti-tumor activity in preclinical studies with good safety. According to preclinical research, H002 exhibits significant anti-tumor activity against single-point mutations of EGFR (Del19 and L858R), double mutations (Del19/C797S, L858R/C797S, Del19/T790M, and L858R/T790M), and triple mutations (Del19/T790M/C797S and L858R/T790M/C797S). Preclinical results also indicate that H002 has potential efficacy for EGFR-positive brain metastatic tumors.

H002 has been approved for clinical Phase I/IIa studies in the United States and China. RedCloudBio plans to develop H002 globally as an entirely new next-generation EGFR kinase inhibitor to address significant unmet clinical needs, such as resistance to third-generation EGFR TKIs in non-small cell lung cancer treatment.

About RedCloudBio

RedCloudBio is an innovative drug discovery company at the forefront of focusing on the dynamic structures of proteins and drug complexes, with structural pharmacology and computational technology at its core. RedCloudBio has established research and development centers in Shanghai and Beijing, possessing a small molecule drug discovery platform that integrates molecular dynamics simulations/computational chemistry and artificial intelligence (AI) technologies around a core of structural pharmacology, as well as global clinical development capabilities.

RedCloudBio has accumulated a wealth of structural data and algorithm models in multiple target areas focused on clinical needs, and has developed several small-molecule precision drug research and development pipelines, covering cancer and other therapeutic areas with high unmet clinical needs. H002, the first innovative drug candidate independently developed by RedCloudBio, targets various drug-resistant EGFR mutations and is a potential next-generation non-small cell lung cancer drug with unique clinical differentiation. Global clinical studies for H002 have currently been initiated.