REDCLOUD BIO ANNOUNCES FDA ACCEPTANCE OF IND APPLICATION FOR NEXT-GENERATION EGFR INHIBITOR H002 IN NON-SMALL CELL LUNG CANCER

Drug Candidate Is First From Company To Enter Phase I/IIa Clinical Trial
H002 Has Potential To Overcome Resistance Driven By Various EGFR C797S-Containing Mutations in Non-Small Cell Lung Cancer
RedCloud Bio (the “Company”), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug development, announced today that the US Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application, clearing the path to proceed Phase I/IIa clinical investigation of H002, a broad spectrum, highly selective, fourth-generation compound. The candidate will be initially evaluated for treating C797S mutation-driven resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC). H002 is the first drug candidate expected to enter clinical trials from RedCloud Bio’s pipeline.

“The IND acceptance and anticipated start of our global clinical studies, represent important milestones in our Company’s growth and validation of our internally developed small molecule discovery platform,” said Mai-Jing Liao, Ph.D., CEO of RedCloud Bio.

H002 was developed with RedCloud Bio’s proprietary small molecule drug discovery platform. The platform combines computational approaches, including computational chemistry and artificial intelligence (AI), with structural pharmacology that differentiates interactions between drug candidates and disease-causing mutations of target proteins at an atomic level.

“TKIs can afford an important therapeutic option for NSCLC patients. However, emergence of resistant mutations to successive generations of therapeutics can compromise TKIs’ efficacy,” noted Dr. Liao. “The C797S mutation, in combination with several other mutations, has emerged as one of the most common mechanisms for on-target resistance to third-generation EGFR TKIs such as osimertinib. These combinations have been found in seven to fifteen percent of third generation TKI-treated NSCLC patients.”

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 in laboratory studies. High bioavailability and favorable tissue distribution as well as a wide therapeutic window have also been observed in preclinical studies.

Studies have demonstrated that H002 has high selectivity, a wide spectrum and potent anti-tumor activity against various EGFR activating mutations, as well as favorable safety profiles. RedCloud Bio expects to develop H002 as a next-generation EGFR inhibitor, targeting high unmet medical needs in EGFR-mutated NSCLC, including emerging drug resistance to existing EGFR TKI.

Source: RedCloud Bio