In recent years, the frontier development of domestic innovative drugs is no longer a simple Me-too/Me-better, but a higher-end Best/First-in-class. Previously, a policy document on "supporting innovative drugs in the whole chain" released by the market has ignited a bright light for the future development of innovative drugs and market investment. This is undoubtedly a huge benefit for Laekna Pharmaceutical, which has always adhered to differentiated innovation and research and development.
Zhitong Financial APP learned that 2023 is a key year for Laekna Pharmaceutical-B (02105) to make important progress in differentiated innovation and research and development. Therefore, looking at the progress of the company's pipeline research and development through the financial report data can give investors a clearer understanding of the company's leapfrog development.
On March 26, Laekna Therapeutics disclosed its 2023 annual results, demonstrating the significant progress the company has made in efficiently and solidly advancing the development of clinical and preclinical drug candidates and expanding its product pipeline.
Afuresertib Rapidly Advances Clinical Trials of the World's Top Two AKT Inhibitors
Since its listing on the Hong Kong Stock Exchange in 2023, Laekna has been committed to further focusing on unmet clinical needs and continuously enhancing the value of its pipeline. Among them, the R&D progress of the core product AKT inhibitor Afuresertib (LAE002) is obviously one of the highlights of the company's financial report.
As a potent inhibitor of AKT, afuresertib inhibits all three AKT subtypes (AKT1, AKT2 and AKT3) and is one of only two anti-cancer AKT inhibitors in the world that are in or have completed pivotal clinical development.
Last year, the company efficiently and solidly promoted clinical trials around this potential innovative drug, and made the following important progress:
Afuresertib+氟维司群治疗HR+/HER2-乳腺癌,Ib/III期
The results of the Phase 1b study were presented in a poster highlight section of the 2023 San Antonio Breast Cancer Symposium (SABCS) in December 2023. A pivotal phase III trial of afuresertib in combination with fulvestrant in patients with HR+/HER2–LA/mBC has been initiated.
Afuresertib+LAE001/泼尼松治疗前列腺癌, II期
The Company has completed a Phase II international multicenter trial in patients with metastatic castration-resistant prostate cancer (mCRPC) following SOC therapy in the U.S. and South Korea, showing promising outcomes. The detailed results of the study were presented at the European Society for Medical Oncology (ESMO) in October 2023. The subsequent pivotal trial design is being discussed with regulators.
Afuresertib + paclitaxel in platinum-resistant ovarian cancer, pivotal phase II
The company's international multi-center clinical trial in China and the United States announced topline data in January 2024 for platinum-resistant ovarian cancer. In the ITT population-wide group, it was effective in reducing the risk of disease progression or death by about 26%, but the trial did not reach statistical significance. In the biomarker-positive subgroup, afuresertib combination treatment group significantly improved PFS. The Company plans to discuss with regulatory authorities the results of this trial to determine the next steps for registrational clinical pathways.
LAE102 is deeply involved in activin channel-related diseases such as obesity
LAE102 is the company's first self-developed monoclonal antibody against ActRIIA. Blocking the Activin-ActRII pathway promotes skeletal muscle regeneration and fat reduction.
The Company is exploring the application of LAE102 in other disease indications such as obesity. In the first quarter of 2024, the company submitted IND applications for LAE102 for the indication of obesity to the China CDE and the U.S. FDA, respectively. Once the IND is approved, the company plans to start the clinical trial process and is committed to providing precision treatment to obese patients who need novel treatment options.
It is worth mentioning that the Laekna team has accumulated rich experience and deep expertise in this specific field, and is developing more drug candidates to maximize the medicinal value of targeting the ActRII receptor. LAE103 is a selective antibody to ActRIIB and LAE123 is a dual-target inhibitor of ActRIIA/IIB, both of which are independently developed by the company for muscle regeneration and related disease indications.
Independent innovation has accumulated steadily, and 7 projects have entered the preclinical drug candidate (PCC) stage
As of December 31, 2023, Laekna's early-stage R&D team has internally identified 14 drug candidates, seven of which have completed molecular optimization and advanced to the preclinical candidate (PCC) stage:
LAE103 (ActRIIB monoclonal antibody for muscle regeneration indications); LAE105 (a bifunctional aHSC-NK conjugate with sHSC killing and antifibrotic activity); LAE111 (a LILRB1 and LILRB2 bispecific antibody); LAE112 (an FGFR2b monoclonal antibody); LAE113 (a TIGIT-PVRIG bispecific antibody); LAE119 (a selective inhibitor of PARP1); and LAE120, a USP1 inhibitor.
The company plans to advance one drug candidate into the clinical stage each year, and LAE120 has initiated IND-enabling.
"After its listing on the Hong Kong Stock Exchange in 2023, Cocis Biosciences will further focus on unmet clinical needs and continue to increase the value of its pipeline. Dr. Xiangyang Lu, Chairman of the Board of Directors of Laekna Therapeutics, said that the first Phase III pivotal clinical study of the core AKT inhibitor Afuresertib (LAE002) has been initiated, and we look forward to benefiting breast cancer patients around the world as soon as possible. The self-developed potential next-generation weight loss and muscle-building innovative drug LAE102 (ActRIIA antibody) has achieved both China and the United States.
It is predicted that the number of obese people in the world will reach 1.2 billion by 2030. Dr. Xiangyang Lv emphasized, "With our extensive experience and expertise in the specific area of blocking the Activin-ActRII pathway, we are developing more drug candidates to provide precision therapies for patients with diseases such as obesity and muscular dystrophy who are in dire need of novel treatment options. ”