-  Initiated SC cohort in the Phase I SAD Study of LAE102

-  Early indications of target engagement and expected changes in PD biomarkers have been observed in the IV dose cohorts

- On track to achieve primary completion of SAD studies before the end of 2024

October 16, 2024 — Laekna, Inc. (2105.HK) (“Laekna”) today announced that the Group has initiated LAE102 subcutaneous dosing (the “SC”) cohort in its phase I single ascending dose study (the “SAD Study”). The phase I clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of LAE102 administered both intravenously and subcutaneously. The phase I clinical trial is progressing effectively. As of end of September 2024, more than half of the planned cohorts in intravenous injection (“IV”) route of administration have been dosed. Early signs of target engagements and expected pharmacodynamic biomarker changes have been observed. The Group is on track to achieve primary completion of the SAD Study before the end of 2024.

LAE102 is an internally discovered first-in-class monoclonal antibody targeting ActRIIA selectively, a receptor that plays an important role in muscle regeneration and lipid metabolism. LAE102 has shown to increase lean mass and decrease fat mass in pre-clinical models. In combination with a GLP1R agonist, LAE102 can further reduce fat mass and significantly regain the lean mass loss induced by GLP1R-agonist. This positions LAE102 as a promising drug candidate for achieving quality weight control.

“Globally, the number of people living with obesity will reach over 1.2 billion by 2030.¹ The causes of obesity are complex and, so often, it puts people on a path to other associated diseases — for examples, diabetes, heart and liver diseases, and many more.", said Dr Chris LU, Chairman and CEO of Laekna, “Obesity patients and physicians are setting higher expectations on quality, safety and persistency of weight loss management. The SC route of administration is highly preferred for chronical uses, and makes it easier to be administered with a GLP1R agonist. We are encouraged by the early findings of target engagements and changes in PD biomarkers observed in the low dose cohorts, which increases the likelihood of developing a subcutaneous dosing regimen. 

¹  Source: World Obesity Federation, 2023b

—End—

Contact Us

IR  ir@laekna.com

Media  communication@laekna.com

Corporate and Business Development  BD@laekna.com

About LAE102

LAE102 is Laekna’s internally discovered 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 potential 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 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

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.