Pharma Focus Asia

Laekna Gains FDA Approval for Phase III Trial of LAE002 (Afuresertib) and LAE001 in Prostate Cancer Treatment

Friday, May 24, 2024

Laekna, Inc. (2105.HK), a leading biotechnology company, has achieved a significant milestone with the approval from the U.S. Food and Drug Administration (FDA) for the phase III clinical trial protocol of LAE002 (afuresertib), an AKT inhibitor, combined with LAE001 (a dual inhibitor of CYP17A1/CYP11B2), referred to as LAE201. This groundbreaking trial targets patients with metastatic castration-resistant prostate cancer (mCRPC) who have undergone standard treatment protocols.

Laekna commenced the Phase II clinical trial of LAE201 in multiple regions, including the U.S. in June 2021 and South Korea in September 2022. This open-label study focuses on dose escalation and expansion to evaluate the efficacy and safety of this innovative combination therapy.

Preliminary results from the study have shown promising outcomes for mCRPC patients. As of November 21, 2023, 40 patients who had experienced progression after 1–3 lines of standard treatments, including at least one line of abiraterone or the second generation of AR antagonists, were enrolled in the recommended phase II dose group. The median radiographic progression-free survival (rPFS) reached 8.1 months, marking a significant improvement compared to the historical median rPFS of 2 to 4 months for mCRPC patients under standard treatments. Moreover, the combination therapy demonstrated manageable adverse events, with patients showing tolerability and recoverability following routine treatments.

Laekna, expressed enthusiasm about the approval, emphasizing the urgent need for novel treatment options for mCRPC patients who have exhausted traditional therapies. The approval of the phase III trial protocol represents a crucial step forward in addressing this unmet medical need.

Afuresertib (LAE002) is a potent AKT inhibitor that targets all three AKT isoforms (AKT1, AKT2, and AKT3). It stands out among AKT inhibitors for its superior efficacy, potency, tumor inhibition exposure, and safety profile. Meanwhile, LAE001, a dual inhibitor of CYP17A1/CYP11B2, inhibits both androgen and aldosterone synthesis without the need for prednisone, potentially minimizing adverse events associated with steroid use.

In addition to prostate cancer, Laekna is exploring the therapeutic potential of afuresertib across various cancers, including breast cancer, ovarian cancer, and PD-1/PD-L1 drug-resistant solid tumors. The company's commitment to addressing unmet medical needs underscores its dedication to advancing precision therapies for patients worldwide.



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