Laekna has dosed the first subject in the Phase I/II LAE201INT2101 clinical trial of a combination of LAE001 and LAE002 (afuresertib) in metastatic, castration-resistant prostate cancer (mCRPC) patients in South Korea.

The first participant received the treatment dose at Seoul National University Hospital. 

This open-label, multicentre, dose-escalation and efficacy trial will assess the combination therapy in mCRPC patients whose disease progressed or are intolerable to standard of care (SOC) treatment. 

The Phase I dose-escalation stage has concluded and the company is now commencing the Phase II stage of the Proof-of-Concept trial.

Apart from Seoul National University Hospital, the company has begun the study at four other sites in South Korea. 

The trial is also underway in over ten sites across the US.

The combination treatment is anticipated to offer benefits for patients who have advanced following therapies of the new-generation A/AR drugs, including abiraterone and enzalutamide. 

An investigational androgen synthesis inhibitor, LAE001 hinders aldosterone synthase CYP17A1 and CYP11B2 at the same time to treat prostate cancer.

LAE002 is a highly selective adenosine triphosphate (ATP) competitive AKT inhibitor. It is being investigated to treat ovarian, prostate, and breast cancers, as well as PD-1/PD-L1 drug-resistant solid tumours. 

Laekna chief medical officer Dr Yong Yue said: “Based on our clinical team’s strategy and execution capabilities, our trials are now ongoing in more than 90 clinical sites in China, the United States, and South Korea. 

“We are rapidly advancing a number of multi-regional clinical trials to better evaluate the value of our drugs in the treatment of various cancers, and we hope to enable our innovative therapies to benefit more patients worldwide as soon as possible.”

In May this year, the company dosed the first two subjects in the US and China, respectively, in a Phase Ib/III trial of afuresertib plus fulvestrant in breast cancer patients.