Laekna Receives FDA Approval for Phase III Trial of LAE002 and LAE001 in Prostate Cancer

Laekna, Inc., a biotechnology company listed on the Hong Kong Stock Exchange (2105.HK), has secured approval from the U.S. Food and Drug Administration (FDA) for the protocol of its Phase III clinical trial. This trial will investigate the efficacy of a combination therapy involving two drugs, LAE002 (afuresertib) and LAE001, in treating metastatic castration-resistant prostate cancer (mCRPC) that has progressed despite standard care treatments.

The Phase II clinical trial of LAE201, also known as afuresertib combined with LAE001, showed promising results. Initiated in the United States in June 2021 and extended to South Korea in September 2022, the open-label study assessed the safety and efficacy of the combination therapy. By November 2023, 40 patients who had previously undergone 1 to 3 lines of standard treatments, including at least one line of abiraterone or second-generation androgen receptor (AR) antagonists, were enrolled in the Phase II dose group. The median radiographic progression-free survival (rPFS) for these patients was 8.1 months, a significant improvement compared to the historical median rPFS of 2 to 4 months for mCRPC patients under standard treatments. The combination therapy was generally well-tolerated, with manageable adverse events.

Dr. Yong Yue, Chief Medical Officer of Laekna, highlighted the significance of the FDA's approval. "This approval is a milestone for Laekna," he said. "The results from our Phase II trial showed encouraging anti-tumor activity and a good safety profile for patients with mCRPC. The Phase III trial will further investigate this combination in a patient population with a high unmet medical need. We are eager to advance this therapy to offer new treatment options for mCRPC patients."

Afuresertib (LAE002) is a potent AKT inhibitor targeting all three AKT isoforms (AKT1, AKT2, and AKT3). It has demonstrated several advantages over other AKT inhibitors, such as higher efficacy and better safety profile. Afuresertib is one of only two AKT inhibitors globally in or completed pivotal-stage clinical development for cancer treatment. Laekna has also initiated a Phase III study for afuresertib in HR+/HER2- breast cancer following promising results from a Phase Ib study presented at the San Antonio Breast Cancer Symposium (SABCS) in 2023.

LAE001, licensed from Novartis in 2017, is a dual inhibitor of CYP17A1 and CYP11B2, which plays a key role in androgen synthesis. This dual inhibition can block both androgen and aldosterone synthesis, potentially administering without the need for prednisone. LAE001 is the only dual CYP17A1/CYP11B2 inhibitor currently in clinical trials for prostate cancer globally.

Established in 2016, Laekna is dedicated to developing novel therapies for cancer, metabolic diseases, and liver fibrosis. As of the end of 2023, the company had initiated six clinical trials for afuresertib (LAE002), LAE001, and LAE005 targeting various cancers, including breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1 drug-resistant solid tumors. The company's internal drug discovery platform has also produced 14 drug candidates, including LAE102, an antibody against ActRIIA for treating obesity.

Laekna's stock began trading on the Main Board of the Hong Kong Stock Exchange on June 29, 2023. The FDA's protocol approval for the Phase III trial of LAE002 and LAE001 marks a step forward in Laekna's mission to address unmet medical needs with innovative treatments.