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2023 ESMO│Laekna (2105.HK) Announces Phase I/II Data of LAE001 plus afuresertib in mCRPC


The combination therapy demonstrated positive anti-tumor activity and safety in patients with mCRPC


The combination therapy of LAE001 plus afuresertib achieved a median rPFS of 7.9 months in 40 patients who had progressed on 1-3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation of AR antagonists


Among 12 patients with measurable lesions at baseline based on RECIST 1.1, two confirmed PRs and two unconfirmed PRs were observed


The combination therapy has showed good safety and tolerability in mCRPC patients


Investigators believe that the combination therapy showed the potential clinical benefits in drug-resistant mCRPC patients and support the study to move forward to the registration phase


Shanghai, China and New Jersey, U.S., October 24, 2023 —Laekna (2105.HK) announced that the efficacy and safety data from the Phase I/II study of LAE001/prednisone plus afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC) progressed on 1-3 prior lines of standard of care has been presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain.


The Phase I/II trial is an open-label, dose-escalation and dose expansion study to assess the efficacy and safety of the combination candidate. It was led by Professor Elan Diamond from New Jersey Urology, LCC and conducted across 18 research centers in the U.S. and five research centers in South Korea.


Encouraging Clinical Data


As of September 1, 2023, 40 patients who progressed on 1-3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation of AR antagonists, had been enrolled in the recommended phase 2 dose group. The median rPFS was 7.9 months, 95% CI: (5.7m, NE). This is a significant improvement compared to the median rPFS of 2 to 4 months of mCRPC patients under the standard treatments historically.


Among 12 patients with measurable lesions at baseline based on RECIST 1.1, two confirmed PRs and two unconfirmed PRs were observed. The combination therapy was generally tolerable with manageable TEAEs and recoverable after routine treatments.


Investigators support moving forward to the registration phase


Dr. Bamidele A. Adesunloye from City of Hope Atlanta, Georgia, attended the ESMO congress as a representative of the investigators of the study. Dr. Elan Diamond, the primary investigator of the study, believes that LAE001 plus afuresertib has shown encouraging anti-tumor activity and safety in mCRPC patients who have progressed on the standard of care treatments (1-3 lines of new-generation anti-androgen therapy and/or chemotherapy). Safe and effective doses of afuresertib plus LAE001 may have contributed to a greater clinical benefit. The investigators unanimously support moving forward to the registration phase.


“It's great to see Lakena once again presenting the latest clinical trial data of its innovative therapy candidate in mCRPC patients at ESMO Congress," said Dr. Yue Yong, Chief Medical Officer of Laekna. “LAE001, a novel dual inhibitor of CYP17 and CYP11B2 (aldosterone synthase), mitigates hypertension, hypokalemia, and other effects of hyperaldosteronism. Afuresertib is an AKT inhibitor targeting the PI3K/AKT/mTOR signaling pathway that is commonly activated upon drug resistance in many cancers, especially in drug-resistant mCRPC, which is believed to be as many as 50-70% of patients with PI3K/AKT/PTEN alterations. Currently, there is no targeted therapy which inhibits overactive PI3K/AKT/PTEN signaling pathway has been approved for the treatment of patients with mCRPC. We hope that the combination of LAE001 plus afuresertib can provide a new efficacious and safe treatment option for drug-resistant mCRPC patients.”


Learn more from the abstract




About The Study


The Phase I/II study of LAE001/prednisone plus afuresertib in patients with metastatic castration-resistant prostate cancer (mCRPC) following 1-3 lines of standard of care is an open-label, dose-escalation, efficacy, and safety study.


The Phase I dose-escalation study aimed to identify the recommended Phase II dose (RP2D) to assess the anti-tumor efficacy and safety of LAE001 plus afuresertib in patients with mCRPC.


The Phase II part of the study aimed to assess preliminary efficacy of LAE001 plus afuresertib by rPFS in mCRPC patients who progressed on, or who are intolerant of, 1-3 prior lines of therapies, including at least one second-generation anti-androgen treatment.


About Laekna

Stock Code: 2105.HK


Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer and liver fibrosis patients worldwide.


As of June 30, 2023, Laekna has initiated six clinical trials for Afuresertib (LAE002), LAE001 and LAE005 to address unmet medical needs in cancers, such as ovarian cancer, breast cancer and prostate cancer. Among the six clinical trials, three are multi-regional clinical trials (MRCTs) , including one pivotal trial.


Laekna’s internal drug discovery platform has discovered 12 drug candidates. LAE102 is our first internally discovered antibody which has obtained the IND approval from FDA. Its potential indications include muscle regeneration, obesity and cancer.


Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023, the stock code is 2105.HK.


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