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)