LAE002 is an ATP competitive AKT inhibitor for the treatment of ovarian cancer, prostate cancer, breast cancer and PD-1/PD-L1 drug-resistant solid tumors. 

Laekna in-licensed LAE002 from Novartis in 2018. Prior to our in-licensing, 11 clinical trials had been conducted to demonstrate the safety and efficacy profiles of LAE002 by Novartis and GlaxoSmithKline plc.

In the Phase I/II study conducted by Novartis, LAE002 showed potential anti-tumor efficacy in PROC patients. In pre-clinical studies, LAE002 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, prednisone and LAE001 and observed their synergistic anti-tumor efficacy in mCRPC patients as second- to fourth-line treatments.

According to Frost & Sullivan, there are two AKT inhibitors that have entered registrational clinical trials globally.

LAE001 is an androgen synthesis inhibitor that inhibits both CYP17A1 and CYP11B2 for the treatment of prostate cancer.

Laekna in-licensed LAE001 from Novartis in 2017. According to Frost & Sullivan, LAE001 is the only dual CYP17A1/CYP11B2 inhibitor in clinical trial for the treatment of prostate cancer globally. Abiraterone acetate, a CYP17A1 enzyme inhibitor, is currently approved only for use in combination with prednisone. Prolonged cumulative doses or short-term high dose exposure to prednisone may lead to adverse events.

Our completed Phase I study showed safety, preliminary anti-tumor efficacy and potential clinical benefits for LAE001 monotherapy without the use of prednisone in mCRPC patients. We are currently conducting a Phase II clinical trial of LAE001 monotherapy on mCRPC.