SHANGHAI and WARREN, N.J., Sept. 6, 2022 /PRNewswire/ — Laekna, a clinical-stage biotechnology company dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide, announced yesterday that the first patient recently received a dose in the LAE201INT2101 phase I/II study at Seoul National University Hospital. The company’s multi-regional clinical trials (MRCTs) now cover China, the United States and South Korea.
LAE201INT2101 is a multi-center, open-label, phase I/II dose-escalation and efficacy study of the LAE001 and LAE002 (afuresertib) combination in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression or intolerability following standard of care (SOC) treatment. Laekna has finished the phase I dose-escalation stage and is starting the phase II stage of the Proof-of-Concept study now.
Metastatic castration-resistant prostate cancer is one of the most intractable cancers. The combination therapy of LAE001 and LAE002 (afuresertib) is expected to provide treatment benefits for patients who progressed after treatments of the new-generation A/AR drugs including abiraterone and enzalutamide. LAE001 inhibits both CYP17A1 and CYP11B2 (aldosterone synthase) as a next-generation anti-androgen inhibitor. LAE002 (afuresertib) is a highly selective AKT kinase inhibitor. Both are the company’s potential core products.
In addition to Seoul National University Hospital, Laekna has already initiated trials in four other clinical sites in South Korea. The study is also ongoing in more than 10 sites across the United States.
“We have been committed to ‘global development and marketing’ since the inception of the company. 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,” said Dr. Yong Yue, Chief Medical Officer of Laekna. “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.”
Founded in 2016, Laekna is a clinical-stage biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide.
Laekna has two potential core products: LAE002 is an investigational highly selective adenosine triphosphate (ATP) competitive AKT inhibitor for the treatment of ovarian cancer, prostate cancer, breast cancer and PD-1/PD-L1 drug-resistant solid tumors. The other core product LAE001 is an investigational androgen synthesis inhibitor that simultaneously inhibits both CYP17A1 and CYP11B2 for the treatment of prostate cancer.
Laekna’s robust infrastructure has already enabled the rapid development of 14 innovative product candidates, including one pivotal clinical trial and another five clinical trials for its potential core products. Among these six clinical trials, three multi-regional clinical trials (MRCTs) are designed to address urgent yet unmet global medical needs in the standard of care (SOC)-resistant cancers.
Laekna’s internal drug discovery primarily focuses on coordinating the human immune system to treat cancer and liver fibrosis.