On July 27, 2023 Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, reported that it has initiated dosing with its orally bioavailable pan-TRK degrader, CG001419, in a Phase I/II clinical trial for patients with solid tumors (Press release, Cullgen, JUL 27, 2023, View Source [SID1234633471]). CG001419 is a potential first-in-class, highly active small molecule developed to selectively degrade both mutant and wild-type TRK proteins. In preclinical research, CG001419 demonstrated strong potency against solid tumors harboring various oncogenic TRK abnormalities, such as NTRK gene fusions and wild-type TRK protein over-expression.
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"We are excited to initiate human dosing for CG001419," said Dr. Ying Luo, Chairman and CEO of Cullgen, "This is a significant milestone for Cullgen as it marks our first entry into the clinic for one of our targeted protein degraders. I am very proud of the progress that our entire company has made to advance our first program into the clinic in only a few years since inception of the program."
The first-in-human trial of CG001419 is a Phase I/II trial with adaptive design. The Phase Ia portion of the trial is an open label, non-randomized, dose escalation study to evaluate the safety, tolerability, PK profile, and preliminary efficacy of CG001419 in patients with advanced or metastatic solid tumors, particularly those harboring NTRK gene fusions, point mutations, amplifications or over-expression. Patients that complete the Phase Ia trial may transition into the Phase Ib or Phase II portions of the trial depending on safety and tolerability results, the patient’s NTRK aberration type, and the judgment of physicians. Compared with traditional kinase inhibitor drugs approved in treating cancer with NTRK gene fusions, CG001419 may offer potential advantages in overcoming secondary drug-resistant mutations in NTRK fusions, as well as an expanded clinical profile to include cancers with other NTRK gene/TRK protein abnormalities.