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Laekna Therapeutics Receives IND Approvals in China and US for Phase Ib/III Global Multi-center Clinical Study of Afuresertib in combination with fulvestrant for patients with HR+/HER2- breast cancer

Laekna Therapeutics Receives IND Approvals in China and US for Phase Ib/III Global Multi-center Clinical Study of Afuresertib in combination with fulvestrant for patients with HR+/HER2- breast cancer

-The LAE205INT3101 phase Ib/III Clinical trial is kicked off in the US and China simultaneously, one month earlier than expected

-Afuresertib is now in multiple clinical trials in four different cancers in the US and China

-Patients with HR+/HER2- breast cancer account for the largest subgroup of breast cancer. There is urgent need for new treatment options after patient becomes resistant to prior standard-of-care therapies

SHANGHAI and WAREN, New Jersey, Aug. 27, 2021 /PRNewswire/ -- Laekna Therapeutics announced today 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.

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 AfuresertibLAE002

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.

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an emerging innovative pharma company based in China's "Zhangjiang Pharma Valley" and New Jersey in the US, focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases.

Laekna Therapeutics has adopted a two-pronged strategy in new drug development. On  one hand, it continues to enrich its portfolio by introducing global new drugs with the clinical Proof of Concept. The company has obtained the global exclusive rights of four new drug candidates from Novartis. On the other hand, the company's self-developed innovative drugs will soon enter clinical development stage.

Laekna has set up a team of top global pharmaceutical talent. Its leadership team members each have over 20 years of experience in new drug development in China and the US, with an exceptional track record in R&D, new drug approvals and commercialization. Laekna is committed to a science-based, innovation-driven approach to create an international leading clinical research and development platform for the development of first-in-class and best-in-class innovative drugs.

The detail Laekna Therapeutics information can be found from the website:

Contact Laekna Therapeutics
Leah Liu  CFO

Cleo Zhang

Corporate and Business Development
Guy Rosenthal (US)

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