-   Initiated the Phase III pivotal trial of afuresertib in combination with fulvestrant in patients with HR+/HER2-LA/mBC

-   Submitted IND applications to CDE and FDA for LAE102, our internally discovered monoclonal antibody against ActRIIA, for obesity indication

-   Internally discovered 14 drug candidates and advanced seven as PCC drug candidates

-   Cash and bank balances were RMB778.9 million

March 27, 2024 - Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced the consolidated annual results for the year ended December 31, 2023.The company has made significant progress with respect to the development of clinical and pre-clinical candidates and expansion of its product pipeline.

"Since our listing on the Hong Kong Stock Exchange in 2023, we’ve been focusing on the unmet medical needs and increasing further the value of our pipeline. We’ve initiated the first phase III pivotal trial of the AKT inhibitor afuresertib (LAE002), one of our core products, and expect to benefit patients with breast cancer globally. We’ve submitted IND applications to CDE and FDA in China and in the US, respectively, for LAE102, our internally discovered monoclonal antibody against ActRIIA which has been shown to increase lean mass and decrease fat mass in pre-clinical models ", said Dr. Chris Lu, Chairman of Laekna. 

" It is estimated that the number of obesity patients worldwide will exceed 1.2 billion by 2030¹. Laekna team has accumulated tremendous experiences and deep knowhow in the research and development of blocking Activin-ActRII pathway. We are developing more drug candidates to bring precision therapies to patients with obesity or myotrophy diseases who are in urgent needs of the novel treatment options."

¹World Obesity Federation, 2023b

Business Highlights

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.

-   Afuresertib +Fulvestrant in HR+/HER2-breast cancer, Phase Ib/III

The results of a Phase Ib study were presented during a poster spotlight session at the 2023 San Antonio Breast Cancer Symposium (SABCS) in December 2023. Currently, the Phase III pivotal trial of afuresertib in combination with fulvestrant in patients with HR+/HER2-LA/mBC has been initiated.

-   Afuresertib +LAE001/prednisone in mCRPC, Phase II

The company has completed a Phase II clinical trial of the MRCT study in patients with mCRPC following SOC treatment in the U.S. and South Korea.

The study demonstrated promising treatment benefit for mCRPC patients. The detailed study readouts including efficacy and safety data was presented in the European Society for Medical Oncology (ESMO) Congress in October 2023. A following pivotal trial design is under discussion with regulatory agencies.

-   Afuresertib (LAE002) +Paclitaxel for PROC (PROFECTA-II), Phase II pivotal

The company has initiated a global MRCT Phase II pivotal trial (PROFECTA-II) in both the U.S and China and announced the Top-line data in January 2024. The study showed reduced risk of disease progression or death (progression-free survival; PFS) with a HR of 0.744 (95% CI: 0.502–1.102) but missed statistical significance. For biomarker subgroup with phospho-AKT positive, study data demonstrated that afuresertib combination arm significantly improved PFS. The company will discuss the results with regulatory authorities to identify a registration path for PROC patient population that may benefit from afuresertib.

LAE102 IND Applications

LAE102 is Laekna’s internally discovered monoclonal antibody against ActRIIA. Blocking Activin-ActRII pathway could promote skeletal muscle regeneration and decrease fat mass.

Laekna is exploring LAE102 in obesity. We submitted IND applications to CDE and FDA respectively for LAE102 in relation to obesity in the first quarter of 2024. And we plan to commence clinical trial process after obtaining IND approval and is committed to bringing this precision therapy to obesity patients who are in needs of the novel treatment options.

Laekna team has accumulated tremendous experiences and deep knowhow in this specific field and are 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.

Pre-clinical candidates (PCC) declaration

For the year ended December 31, 2023, Laekna’s internal drug discovery platform has discovered 14 drug candidates, among which seven have been optimized and advanced to PCC (pre-clinical candidate) stage.

LAE103, monoclonal antibody against ActRIIB for indications related to muscle regeneration; LAE105, a bi-functional aHSC-NK engager with sHSC killing and anti-fibrosis activity; LAE111, aLILRB1 and LILRB2 bispecific antibody; LAE112, a FGFR2b monoclonal antibody; LAE113, a TIGIT-PVRIG bispecific antibody; LAE119, a PARP1-selective inhibitor;and LAE120, an USP1 inhibitor.

The company plans to have one drug candidate entering the clinical stage each year. IND-enabling studies have been initiated for LAE120.

Expected Upcoming Milestones

-   Obtaining IND approval of obesity from CDE and FDA for LAE102 in the second quarter of 2024

-   Initiating first-in-human clinical study of LAE102 in the second half of 2024

-   Initiating patient recruitment of Afuresertib+fulvestrant Phase III clinical study in the second half of 2024

-   IND submission for LAE120 in the fourth quarter of 2024

-   Presenting Afuresertib+LAE005+nab-paclitaxel Phase I clinical study results at American Association for Cancer Research annual meeting in April 2024 (AACR 2024)

-   Presenting LAE119/PARP1- selective inhibitor and LAE120/USP1 inhibitor at American Association for Cancer Research annual meeting in April 2024 (AACR 2024)

-   Plan to present Afuresertib + Sintilimab + nab-paclitaxel Phase I clinical study results in a scientific conference in the second half of 2024

-   Plan to present more Afuresertib + fulvestrant Phase Ib clinical data and biomarker data in a scientific conference in second half of 2024

Financial Highlights 

The company adopts a prudent funding and treasury policy, aiming to maintain an optimal financial position and minimal financial risks.

Cash used in operations: RMB 295.6 million

Loss for the year: RMB368.8 million

Cash and bank balances (including cash and cash equivalents and time deposits): RMB 778.9million

Total assets: RMB 932.3 million

-  End –

Contact us

IR  ir@laekna.com

Media communication@laekna.com

Business Development bd@laekna.com

About Laekna

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). Among the 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 first internally discovered antibody against ActRIIA. We submitted IND applications to CDE and FDA respectively for LAE102 in relation to obesity in the first quarter of 2024. Blocking Activin-ActRII pathway could promote skeletal muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experiences and deep knowhow in this specific field and are 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, the stock code is 2105.HK.

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.