SHANGHAI, April 7, 2022 /PRNewswire/ — RedCloud Bio (the "Company"), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug development, announced the upcoming presentation of preclinical data of H002, a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) in non-small cell lung cancer (NSCLC). The data will be presented at the 2022 Annual Meeting of the American Association for Cancer Research (AACR), April 8-13, 2022 in New Orleans. H002 was discovered by RedCloud’s technology platform.

The Company recently (March 2) announced that the US Food and Drug Administration has accepted the Company’s Investigational New Drug application, clearing the path to proceed Phase I/IIa clinical investigation of H002, a broad spectrum, highly selective, fourth-generation compound. H002 will initially be evaluated for treating C797S mutation-driven resistance to EGFR TKIs in NSCLC. H002 is the first drug candidate expected to enter clinical trials from RedCloud Bio’s pipeline.

H002 has demonstrated potential in overcoming resistance in C797S mutations. The compound has also shown significant inhibitory effects on wide spectrum of single, double and triple EGFR mutants. High bioavailability and favourable tissue distribution as well as a wide therapeutic window have also been observed in preclinical studies.

Resistance to EGFR TKIs is a major challenge in NSCLC treatment. EGFR-activating mutations, have been reported in 10-50% of patients with NSCLC. Although these patients respond well to early generations of TKIs, acquired resistance by mechanisms such as T790M mutation compromises their efficacy. Recently, the C797S mutation in combination with Del19 or L858R, with or without T790M, has emerged as one of the most common mechanisms underlying on-target resistance to third generation EGFR TKIs, such as osimertinib. RedCloud Bio is developing a fourth-generation EGFR inhibitor, H002, with a wide spectrum and high selectivity to address the growing unmet needs in NSCLC patients harbouring C797S mutation.

Presentation details:

H002: A wide spectrum, highly selective fourth-generation EGFR inhibitor overcoming resistance harbouring C797S mutation in NSCLC

Abstract #5461, E-Poster Presentation, Session: Experimental and Molecular Therapeutics – Small Molecule Therapeutic Agents, April 8, 2022, 12:00 PM – 1:00 PM CT

(Access to the Abstract:H002: A wide spectrum, highly selective fourth-generation EGFR inhibitor overcoming resistance harboring C797S mutation in 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. The Company has laboratories in Shanghai and Beijing with drug discovery platform integrating structural pharmacology, molecular dynamics, computational chemistry and AI technologies, and with developing global clinical development capabilities.

RedCloud Bio has accumulated structural data and algorithm models covering clinically important targets, and has built an innovative pipeline targeting tumour resistance, rare and other critical diseases with high unmet medical needs, using its core technology platform. The Company’s lead therapeutic candidate, H002, is a small molecule compound addressing EGFR activating mutations, and is expected to enter global clinical development. The compound is a promising candidate as a next-generation TKI with unique clinical differentiation for NSCLC.

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