July 24, 2024 — Laekna, Inc. (2105.HK) today announced that the company will present the end of phase Ib study to evaluate the efficacy and safety of afuresertib plus fulvestrant in advanced or metastatic HR+/HER2- breast cancer at the European Society for Medical Oncology (“ESMO”) Congress 2024. Results of the Phase Ib study in all 31 patients and in a subgroup with PIK3CA/AKT1/PTEN alterations from U.S. and China have demonstrated promising anti-cancer efficacy with a well-tolerated safety profile. Laekna has thus commenced a subsequent phase III clinical trial AFFIRM-205 in China for combination therapy in patients with PIK3CA/AKT1/PTEN alterations in May 2024. The recruitment is moving smoothly, ahead of the planned schedule. This phase 1b result increased our confidence in expecting a positive outcome of AFFIRM-205 trial and a successful NDA submission.

The ESMO Congress is a globally influential oncology forum and the ESMO Congress 2024 will be held in Barcelona, Spain from September 13 to 17 2024.

“The results of our Phase Ib study in this combination therapy has shown promising efficacy and well-tolerated safety profile, especially among patients with PIK3CA/AKT1/PTEN alterations. We are thus confident about the coming Phase III study of afuresertib in breast cancer. The Phase III clinical study was commenced in May 2024, which was ahead of planned schedule, and are now advancing in full speed in 47 sites nationwide. We are excited about the efficient progress and are committed to accelerate the progress to address the unmet medical needs of patients.,” said Mr. Keith Chau, Chief Financial Officer of Laekna. “We also made substantial progress in development of our ACTRII portfolio. LAE102 is our internally discovered antibody against ActRIIA. We obtained IND approvals from FDA and CDE for obesity indication in April and May of 2024 respectively. We commenced Phase I clinical study and dosed the first subject in June 2024. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both of them are our internally discovered antibodies for muscle and other disease indications in the drug candidates pipeline.”

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About afuresertib (LAE002)

Afuresertib(LAE002) is one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally.

 Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). Afuresertib has demonstrated several advantages compared to other AKT inhibitors, including higher efficacy, better potency, more significant tumor inhibition exposure and a better safety profile, based on public data. Capivasertib is the first approved AKT inhibitor from AstraZeneca, which FDA approved for HR+/HER2- breast cancer in November 2023.

Our experience in executing and developing combination therapies among our pipeline has well demonstrated our ability to unleash the clinical value of our pipeline products. Our afuresertib combination trial with Fulvestrant has demonstrated great clinical value to treat HR+/HER2- breast cancer patients who have failed prior standard care treatments of endocrine/anti-estrogen therapies including CDK4/6 inhibitors, a big unmet medical need with huge market potential.

About HR+/HER2- Breast Cancer

The latest data released by the International Agency for Research on Cancer (IARC) of the World Health Organization indicated that the estimated number of new cases of breast cancer in 2022 reached 2.29 million worldwide, ranked as the most frequent cancer in females with 666,103 deaths¹. The IARC also reported that breast cancer ranked second among women in China, with an estimated number of 357,161 new cases in 2022².

Approximately 69% of breast cancer patients in the United States were found to be HR+/HER2-³, and the proportion of this subtype among Chinese patients were approximately 62%⁴. Although most of patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel treatment options are urgently needed for patients after drug resistance.

¹ Global Cancer. IARC.  http://gco.iaic.fr/

² Global Cancer. IARC.  http://gco.iaic.fr/

³ Cancer Stat Facts: Female Breast Cancer Subtypes; SEER 22 2016–2020

⁴ Breast cancer subtypes and survival in Chinese women with operable primary breast cancer. Chin J Cancer Res, 2011. 23(2): p. 134-9.

About Laekna

Stock Code: 2105.HK

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). 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 internally discovered antibody against ActRIIA. We’ve obtained IND approvals from the FDA and the CDE in relation to obesity. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experience and deep know-how in this specific field and is 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, with the stock code 2105.HK. 

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

Forward Looking Statements

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