May 13, 2024 — Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the company has obtained the Investigational New Drug(IND) approval from the Centre for Drug Evaluation of the National Medical Products Administration of China (CDE) for LAE102, an internally discovered monoclonal antibody against ActRIIA, for the treatment of patients with obesity, following the U.S. Food and Drug Administration’s IND approval in April. The company is in process to complete the regulatory requirements to commence enrollment of patients for Phase I clinical trial of LAE102 for Treatment of Obesity.

Laekna will pursue strategic partnerships to accelerate the development and commercialization of LAE102 for such important indication with a great unmet medical need. Blocking Activin-ActRII pathway could promote skeletal muscle regeneration and decrease fat mass.

“The IND approvals from the CDE and the FDA for obesity indication reflect our tremendous experiences and deep knowhow in the research and development of blocking Activin-ActRII pathway, as well as the efficiency and robust execution of Laekna's cross-functional teams”, said Dr. Chris Lu, Chairman and CEO of Laekna. The company strives to commence “first patient in” for the clinical study of LAE102 expeditiously and targets to bring this precision therapy to obesity patients around the world.

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About LAE102

LAE102 is a monoclonal antibody against ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism. In the pre-clinical models, LAE102 has been shown to increase lean mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and dramatically attenuates lean mass loss induced by GLP1R agonist. This makes LAE102 a drug candidate for achieving quality weight control through reducing fat while keeping muscle mass.

Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team is developing more drug candidates to maximize the value of targeting ActRII receptors. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor for ActRIIA/IIB. Both are the company’s internally discovered antibodies for muscle regeneration and other disease indications in the drug candidate pipeline.

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, metabolic diseases and liver fibrosis patients worldwide.

As of December 31, 2023, we have initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 for the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/ PD-L1 drug-resistant solid tumors to address the unmet medical needs. Among these six clinical trials, three are multi-regional clinical trials (MRCTs). Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally.

Laekna’s internal drug discovery platform has discovered 14 drug candidates. LAE102 is our internally discovered antibody against ActRIIA. We’ve obtained IND approvals from the FDA and the CDE in relation to obesity. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experience and deep know-how in this specific field and is developing more drug candidates (LAE103 and LAE123) to maximize the value of targeting ActRII receptors. 

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, with the stock code 2105.HK. 

For more information, please visit: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

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