Therapex said it has presented the preclinical trial results of TRX-221, its fourth-generation non-small cell lung cancer (NSCLC) drug candidate, at the American Association for Cancer Research (AACR) 2023 Conference in Orlando, Florida, the U.S., on Tuesday.
TRX-221 is a broad-spectrum fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) candidate that inhibits mutations targeted by first, second, and third-generation EGFR inhibitors (ex19del, L858R, T790M), and the C797S mutation, which emerged after treatment with third-generation EGFR inhibitors such as Tagrisso started being used in the medical field.
According to the company, participants visiting the company's booth paid attention to data showing dose-dependent anti-cancer efficacy in patient-derived organoid xenograft (PDOX) models, which were created by transplanting tumor organoids derived from Tagrisso-resistant lung cancer patients into mice for the first time in the world.
Participants also paid significant attention to data showing a significant increase in survival time compared to the control group when TRX-221 was administered to a Tagrisso-resistant brain tumor mouse model and the drug's blood-brain barrier (BBB) penetration mechanism.
"We were able to share the preclinical results of TRX-221 with lung cancer drug experts and have a lively discussion, which showed the global interest in the fourth-generation EGFR TKI lung cancer drug," Therapex CEO Lee Koo said. "We will continue to promote the excellence of TRX-221 through various domestic and international conferences and accelerate the development and commercialization of the drug."
Lee stressed that his company plans to file a phase 1 investigational new drug (IND) application with the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) in June, with plans to begin the trials in patients in the second half of the year.
The AACR conference, held annually in April, is one of the three largest international scientific meetings in the field of oncology, attracting a global audience of researchers, healthcare professionals, and industry leaders.
The meeting is attended by oncology researchers and pharmaceutical and biotechnology professionals from around the world to share innovative cancer-related treatments and R&D achievements in the field of cancer.
This year's AACR event is being held in Orlando, Florida, through Wednesday.