Laekna Announces a Clinical Collaboration with Lilly to Develop LAE102, a Novel Monoclonal Antibody Targeting Activin Receptor Type 2A for The Treatment of Obesity

2024-11-21 Laekna HaiPress

The collaboration will accelerate the global development of LAE102,a novel Activin Receptor Type 2 A (ActRIIA) Antagonistic Monoclonal Antibody (mAb) for muscle-preserving weight loss in Obesity

LOS ANGELES,Nov. 20,2024 -- Laekna,Inc. (2105.HK)("Laekna"),a global biotech company focused on novel drug development for metabolic and cancer diseases,is pleased to announce a clinical collaboration with Eli Lilly and Company (Lilly),a global leader in cardiometabolic health,including diabetes and obesity,to accelerate the development of LAE102,a novel ActRIIA mAb as a novel treatment for obesity. Accelerating innovative treatments like this hopefully can make a meaningful impact on the obesity epidemic and the lives of millions of people affected by obesity.

Key highlights of the collaboration include:

Clinical development of LAE102 through phase 1 study including obese patients

Lilly will fund,share resources and expertise to accelerate research and development timelines

Laekna retains global rights for LAE102

The collaboration will focus on the development and clinical evaluation of LAE102,an innovative ActRIIA antagonistic mAb that may have potential as a first-in-class therapy in this disease area. ActRIIA is a receptor that has been shown to play a critical role in muscle regeneration and lipid metabolism. LAE102 has been shown to both increase lean mass and decrease fat mass in pre-clinical models. If successful,LAE102 could,in combination with a GLP1R agonist,further reduce fat mass and significantly regain the lean mass loss induced byGLP1Ragonist. This positions LAE102 as a promising complementary drug candidate for achieving quality weight control.

By combining Laekna's novel approach with Lilly's decades-long experience in metabolic diseases,the partnership aims to significantly advance the standard of care in obesity management.

"We are thrilled to collaborate with agreat team at Lilly,a renowned global leader in thefield of obesity and metabolic diseases,to introduce cutting-edge treatment to patients suffering from such a devastating condition," said Dr. Chris Lu,Chairman and Chief Executive Officer of Laekna. "Together with Lilly's vast clinical expertise in the cardiometabolic space,we are optimistic about this collaboration's potential to accelerate the global development of LAE102 and make a meaningful impact on the lives of millions of people affected by obesity."

Lilly will be utilizing Lilly's Catalyze360-ExploR&D (https://www.lilly.com/partners/catalyze) engineto accelerate the development of LAE102.

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 significantly regain thelean 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 therapies topatients withcancer,metabolic diseases and liver fibrosis patients around the world.

As of June 30,2024,Laekna has initiated sevenclinical trials for LAE102,LAE002(afuresertib),LAE001 and LAE005 to address unmet medical needsin 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 approvalsfrom the FDAand 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 experiencesand deep know-how in this specific field and is developing more drug candidates (LAE103and 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.

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