By Fineline Cube China-based Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in the Phase I/II LAE201INT2101 study evaluating the combination of LAE001 and LAE002 (afuresertib) in South Korea. The multi-regional clinical trial (MRCT) now spans China, the United States, and South Korea.
Study Details
LAE201INT2101 is a multi-center, open-label, Phase I/II dose-escalation and efficacy study for LAE001 and LAE002 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after or are intolerant to first-line standard treatment. Laekna has completed the dose-escalation phase and is now advancing to the proof-of-concept stage. The combination therapy aims to provide treatment benefits for patients who have progressed after therapies with new-generation androgen/anti-androgen (A/AR) drugs, including abiraterone and enzalutamide.
Drug Profiles
- LAE001: In-licensed from Novartis, LAE001 is a next-generation anti-androgen inhibitor targeting both CYP17A1 and CYP11B2 (aldosterone synthase). This dual-targeted action eliminates the need for long-term prednisone use in patients under the abiraterone acetate regimen, reducing cardiovascular and hepatotoxicity risks. LAE001 has shown safety and preliminary anti-tumor efficacy in Phase I/Ib studies for mCRPC.
- LAE002 (Afuresertib): Also in-licensed from Novartis, LAE002 is a highly selective AKT kinase inhibitor under development for breast cancer, prostate cancer, ovarian cancer, and solid tumors resistant to PD-1/PD-L1 inhibitors. Preclinical studies demonstrate its ability to restore platinum/paclitaxel sensitivity in PROC cell lines, and a Phase Ib study has shown potential anti-tumor efficacy.-Fineline Info & Tech