On August 26, 2021 Laekna Therapeutics reported that the Center for Drug Evaluation (CDE), the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application of its Category 1 new drug candidate afuresertib (LAE002) in combination with anti-estrogen receptor drug fulvestrant in the Phase Ib/III clinical trial of patients with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Press release, Laekna Therapeutics, AUG 26, 2021, View Source;breast-cancer-301364146.html [SID1234586944]).
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This global multi-center clinical trial will be initiated simultaneously in the United States and China a month earlier than previously planned. The Phase III global registrational study will be started soon after afuresertib plus fulvestrant demonstrates proof of concept results in tolerability and anti-tumor efficacy in patients enrolled in the Phase Ib study.
Clinical trials of afuresertib cover four different cancers
Afuresertib (LAE002) is a clinically proven, with a first-in-class potential, highly potent small-molecule pan-AKT inhibitor. Currently, afuresertib is being studied in global clinical studies in four different cancers including ovarian cancer, prostate cancer, triple-negative breast cancer, and HR+/HER2- breast cancer. In the four ongoing clinical trials, afuresertib is explored in combination with chemotherapy, anti-androgen therapy, anti-PD-L1 monoclonal antibody, and anti-estrogen therapy, respectively.
Aiming to be a first-in-class AKT inhibitor
"The IND approval came one month earlier than expected, demonstrating the NMPA’s prioritization and support for the clinical development of new treatment options for drug resistant breast cancer patients. It also showcases effective collaboration between our teams in the US and China," said Dr. Chris Lu, Chairman and Chief Executive Officer of Laekna Therapeutics. "We continue to be a tier-1 player globally in the development of AKT kinase inhibitors. We are accelerating multiple clinical trials to potentially make afuresertib a potential first-in-class therapy."
Striving to address drug resistance in patients with HR+/HER2- breast cancer
Breast cancer is the most common cancer among women worldwide. About 62% and 68% of all breast cancer patients in China and the US are HR+/HER2- respectively. Current treatment are available in the form of first- and second-line endocrine/anti-estrogen therapies and/or in combination of CDK4/6 inhibitors, or chemotherapy, however, the patients often develop drug resistance after a period of time.
"The HR+/HER2- subtype accounts for the largest subgroup of breast cancer. One of the urgent unmet medical needs is to provide a new therapy after patients develop resistance to prior standard of care treatments. It will also help significantly improve the clinical outcomes and quality of life for patients with breast cancer," said Dr. Yue Yong, Chief Medical Officer of Laekna Therapeutics. "Combination therapies based on afuresertib are being explored in clinical trials in patients with various types of drug-resistant cancers, and results showed preliminary anti-tumor efficacy and manageable safety profiles, particularly in ovarian and breast cancers. We expect these new treatment options will benefit patients and provide doctors with better choices in treating patients with drug-resistant tumors."
About Afuresertib（LAE002）
Afuresertib (LAE002) is a differentiated oral, small molecule pan-AKT kinase inhibitor that has been investigated in over 10 Phase 1/2 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma. These studies have demonstrated that afuresertib has strong anti-cancer activities and a tolerable safety profile. The global randomized, open-label, multi-center Phase 2 PROFECTA-II clinical trial of afuresertib is the world’s first registration-directed clinical study of a pan-AKT kinase inhibitor to treat platinum-resistant ovarian cancer.
In recent years, AKT (a serine/threonine-protein kinase) has emerged as an important mechanism in oncology, as it plays an important role in regulating various cell functions such as metabolism, survival, proliferation, tissue invasion, and chemotherapy resistance. PTEN deletion and AKT/PIK3CA alteration may lead to excessive activation of the AKT signaling pathways, which is one of the key drivers for cancer growth. The increased activation of the AKT signaling pathway is particularly common in recurrent ovarian cancer, breast cancer, and prostate cancer.