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FDA Approves Therapex's Targeted Anti-Cancer Agent for Non-Small Cell Lung Cancer for Phase 1 Clinical Trial
NOTICE
2023-08-29

 

 

TRX-221's anti-tumor effect in EGFR C797S mutant non-small cell lung cancer patients to be confirmed in clinical trial

 

Therapex, a subsidiary of Gradient led by CEO Koo Lee PhD, announced on August 28th that the FDA has approved the Investigational New Drug (IND) application for "TRX-221", a targeted anti-cancer drug for non-small cell lung cancer, paving the way for its Phase 1 Clinical Trial.

 

TRX-221, a fourth-generation EGFR tyrosine kinase inhibitor (Fourth-Generation EGFR-TKI), effectively inhibits C797S mutations which are caused by drug resistance in EGFR-mutant non-small cell lung cancer. The company explained that TRX-221 is a "broad-spectrum drug" demonstrating superior inhibitory activity, even against resistance mutations caused by existing first and second-generation drugs, and that it possesses the ability to permeate the blood-brain barrier (BBB).

 

 

Therapex added that the upcoming clinical trial aims to confirm TRX-221’s anti-tumor efficacy on patients with EGFR C797S mutant non-small cell lung cancer, addressing drug resistance to existing antitumor agents, especially third-generation EGFR-inhibitors, and evaluating its effectiveness against various EGFR mutations. Preclinical data from TRX-221 was previously presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 in April.

 

"We are pleased to announce the initiation of clinical trials for TRX-221, our flagship pipeline," stated CEO Koo Lee PhD. "With this milestone, all executives and employees can now dedicate themselves fully to the development of new drugs, with the aim of successfully launching clinical trials for our other ongoing development projects.”

 

 

Source: HITNEWS, Reporter Nam Dae Yeol (http://www.hitnews.co.kr/news/articleView.html?idxno=47754)