LAE002 is an investigational highly selective adenosine triphosphate (ATP) competitive AKT inhibitor for the treatment of ovarian cancer, prostate cancer, breast cancer and PD-1/PD-L1 drug-resistant solid tumors. 

LAE002 is a highly selective ATP competitive AKT inhibitor. We in-licensed LAE002 from Novartis in 2018 and have completed a Phase I clinical trial regulated by the FDA for mCRPC treatments since the in-licensing. We have engaged in the R&D of LAE002 since 2019 and are conducting five combination therapy clinical trials of LAE002 for the treatment of ovarian cancer, prostate cancer, breast cancer, and PD-1/PD-L1-resistant solid tumors. Prior to our in-licensing, over 10 clinical trials had been conducted to demonstrate the safety and efficacy profiles of LAE002. In the Phase Ib study conducted by Novartis, LAE002 showed potential anti-tumor efficacy in PROC patients with an overall response rate (ORR) of 32.1% and progression-free survival (PFS) of 7.1 months. In pre-clinical studies, LAE002 has demonstrated its ability to restore platinum/paclitaxel sensitivity in PROC cell lines. After the in-licensing, we also identified the therapeutic potential of combining LAE002 and LAE001 and observed their synergistic anti-tumor efficacy in our completed Phase I and ongoing Phase II studies in mCRPC patients as second- to fourth-line treatments. According to Frost & Sullivan, LAE002 is one of the three AKT inhibitors worldwide that have entered pivotal clinical trials.

LAE001 is an investigational potential first-in-class next-generation androgen synthesis inhibitor that simultaneously inhibits both CYP17A1 and CYP11B2 for the treatment of prostate cancer.

We in-licensed LAE001 from Novartis in 2017 and have completed a Phase I clinical trial regulated by the NMPA for mCRPC treatments since the in-licensing. We have engaged in the R&D of LAE001 since 2018.

According to Frost & Sullivan, LAE001 is the only dual CYP17A1/CYP11B2 inhibitor in clinical trials for the treatment of prostate cancer globally. As a dual CYP17A1/CYP11B2 inhibitor, LAE001 eliminates the need for long-term prednisone use under abiraterone acetate regimens, thereby reducing the risk of cardiovascular toxicity and hepatotoxicity. Our completed Phase I/Ib study showed safety, preliminary anti-tumor efficacy and clinical benefits in mCRPC patients. LAE001 is in a Phase II clinical trial in China as a monotherapy for first-line mCRPC treatment.