NEW YORK – RedCloud Bio on Wednesday said the US Food and Drug Administration has accepted an investigational new drug application for H002, a treatment the firm is developing for non-small cell lung cancer patients with EGFR C797S mutation-driven resistance to earlier-generation EGFR tyrosine kinase inhibitors.
H002 is a fourth-generation TKI that RedCloud can now evaluate in a Phase I/IIa clinical trial involving patients who have acquired EGFR C797S mutations following treatment with other EGFR inhibitors such as AstraZeneca's Tagrisso (osimertinib).
According to Shanghai-based RedCloud, preclinical research has demonstrated H002's potential to overcome resistance due to EGFR C797S mutations and inhibit a wide spectrum of single, double, and triple EGFR mutations.
"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," RedCloud CEO Mai-Jing Liao said in a statement.
The firm's small molecule discovery platform combines computational approaches and structural pharmacology to differentiate interactions between drug candidates and disease-causing mutations.
According to Liao, EGFR C797S mutations are among the most common on-target resistance alterations seen in NSCLC patients who have received third-generation TKIs like Tagrisso, showing up in 7 percent to 15 percent of patients.
H002 is RedCloud's first drug candidate to enter clinical trials.