- A significant progress of Laekna following LAE102 (ActRIIA mAb) in internal discovery

- LAE123 will be explored as new treatments in life threatening severe diseases such as PAH, SMA

- Establishing the Activin-ActRII portfolio with Laekna team’s tremendous experiences and deep knowhow 

November 28, 2024 — Laekna, Inc. (2105.HK) (“Laekna”) today announced that the Group has advanced LAE123 to PCC declaration and has initiated an IND-enabling study for LAE123 for the treatment of severe diseases.

This marks another significant progress of Laekna following LAE102(ActRIIA mAb) in internal discovery.

“Both LAE102 and LAE103 are drug candidates of our ActRII portfolio, representing the pioneering internal-discovery initiatives since the company's inception in 2016. With a steadfast commitment to innovation and exploration over the last eight years, we have consistently reached significant milestones”, said Dr. Justin GU, CSO of Laekna. “LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody that can potently block the interaction between ActRIIA/IIB and their ligands, including Myostatin, Activins and Growth/differentiation factors. LAE123 is a strong ActRIIA and ActRIIB blocker which has shown superior potency in cell-based reporter gene assays (RGA), excellent PK and efficacy in animal studies.”

Dr. Chris LU, CEO of Laekna, said: “Following the clinical collaboration with Eli Lilly to accelerate the global development of LAE102, I am glad that LAE123 also made significant progress ". He indicated that dysregulation of ActRII signaling has been implicated in many diseases, such as obesity, sarcopenia, and the other sever diseases. Laekna team has accumulated tremendous experiences and deep knowhow in this specific field and has established the Activin-ActRII portfolio - LAE102 is a ActRIIA selective monoclonal antibody while LAE123 is a dual inhibitor against ActRIIA/IIB. We’re also developing LAE103, an ActRIIB-selective antibody to maximize the value of targeting the ActRII receptors.

“We will explore LAE123 as new treatments in life threatening diseases such as PAH, SMA, etc.”, said Dr. Chris LU.

—End—

About LAE123

LAE123 is an internally discovered monoclonal antibody that dually inhibits ActRIIA/IIB signaling induced by their ligands, including Myostatin, Activins (such as Activin A, Activin B, Activin AB, Activin C, and Activin E), and Growth/differentiation factors (GDFs, such as GDF3 and GDF11). Dysregulation of ActRII signaling has been implicated in many diseases, such as obesity, sarcopenia, and the other sever diseases.

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About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with cancer, metabolic diseases and liver fibrosis patients around the world.

As of June 30, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002(afuresertib), LAE001 and LAE005 to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. It has been shown in the pre-clinical studies to increase lean mass and decrease fat mass. We’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China.

Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experiences and deep know-how in this specific field and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of targeting ActRII receptors. 

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates, covering the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/ PD-L1 drug-resistant solid tumors. LAE002 (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 late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer.

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

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

Forward-Looking Statements

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