The Clinical Advisory Board is a conference body that discusses clinical designs ahead of Investigational New Drug applications. Prominent Korean clinical experts in the lung cancer field participated in the Clinical Advisory Board meeting on this day, including Professor Sang-We Kim MD, Professor Dae Ho Lee MD from Asan Medical Center, Professor Byung Chul Cho MD, Professor Sun Min Lim MD from Yonsei Cancer Hospital, Professor Jin Seok Ahn MD from Samsung Medical Center, and Professor Ki Hyeong Lee MD from Chungbuk National University Hospital, for an in-depth discussion on the development strategy for TRX-221.

TRX-221 is a drug candidate that acts as a broad-spectrum fourth-generation EGFR inhibitor (Broad-Spectrum Fourth-Generation EGFR TKI), targeting not only the resistance mutation C797S that appears after treatment with third-generation EGFR inhibitors widely used for non-small cell lung cancer treatment, such as "Tagrisso" (ingredient name: Osimertinib), but also inhibits mutations targeted by first, second and third-generation EGFR inhibitors (such as Del19, L858R, T790M, etc.)

The clinical advisors who participated in the Clinical Advisory Board meeting confirmed the safety of TRX-221, and its potential as the next-generation EGFR targeted therapy, by confirming its dose-dependent anti-cancer efficacy through daily oral administration in various EGFR-mutant tumor models, including the "C797S" mutation animal model, which was shown not to cause any significant weight loss. 

Of particular note were the results confirming efficacy of TRX-221 monotherapy with "complete response (CR)", that previous competing drugs failed to achieve, in the same Tagrisso-resistant patient-derived orthotopic xenograft (PDOX) model.

CEO Koo Lee PhD of Therapex stated, "Today's meeting is significant as we share the preclinical research results of ‘TRX-221’ with lung cancer specialist physicians and discuss future development strategies together," adding, "Through continuous convening of clinical advisory board meetings in the future and efforts to accommodate the expert advice of the clinical advisors, we aim to develop successful treatment options that address the unmet needs of patients."

Meanwhile, Therapex plans to announce the preclinical results of "TRX-221" at the American Association for Cancer Research (AACR) conference next month, and aims to submit an Investigational New Drug Application (IND) to the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) and the U.S. Food and Drug Administration (FDA) in the first half of this year.

Source: "Daily Today", Reporter Han Jiyeon (http://www.dtoday.co.kr/news/articleView.html?idxno=589714)