• The principal investigator of the study is Professor Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences. The Phase I study enrolled 22 patients with advanced solid tumors.

•  Five patients with triple-negative breast cancer were treated for over 32 weeks, with one patient reaching a duration of 73 weeks.

• The combination therapy of AKT inhibitor afuresertib demonstrated preliminary anti-tumor efficacy in breast cancer patients, which supports further investigation of the combination therapy.

April 9, 2024 — Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that results of the Phase I trial of the AKT inhibitor afuresertib (LAE002) in combination with LAE005 (anti-PDL1 mAb) plus nab-paclitaxel for the treatment of triple-negative breast cancer (TNBC) have been presented at the 2024 Annual Meeting of the American Association for Cancer Research (AACR).

The principal investigator of the study is Professor Binghe Xu from t from the Cancer Hospital of the Chinese Academy of Medical Sciences, a member of Chinese Academy of Engineering. The combination therapy of afuresertib plus LAE005 and nab-paclitaxel is well tolerated and has demonstrated preliminary anti-tumor efficacy in locally advanced/metastatic TNBC who were resistant to prior chemotherapy, immune checkpoint inhibitor therapy, or PARP inhibitor therapy. These findings support further investigation of this combination therapy.

Focusing on triple-negative breast cancer

The trial was a multicenter, open-label, dose-escalation Phase I/II study (NCT05390710) approved by the National Medical Products Administration (NMPA) of China in December 2020.

The Phase I part evaluated the safety, tolerability, and anti-tumor activity of the combination therapy of afuresertib plus LAE005 plus nab-paclitaxel in advanced solid tumors, primarily in TNBC. Key inclusion criteria for the Phase I part included advanced solid tumors (TNBC preferred) that progressed after 0-3 lines of standard treatment, ECOG score 0-1, and measurable lesions according to RECIST 1.1 criteria.

As of December 11, 2023, a total of 22 patients with advanced solid tumors were enrolled and dosed in the Phase I part, among which there were 14 TNBC patients who completed at least 2 cycles of treatment and had at least 1 tumor assessment. The median value of previous treatment lines of these 14 patients was 1.5 (0-3).

Five TNBC patients were treated for more than 32 weeks, with one reaching 73 weeks

Professor Pin Zhang from the Cancer Hospital of the Chinese Academy of Medical Sciences said the results of this study showed that among the 14 TNBC patients who completed at least 2 cycles of treatment and had at least 1 tumor assessment, five showed confirmed partial response (ORR 35.7%), four had stable disease (28.6%), resulting in a disease control rate (DCR) of 64.3% in the best response assessment. The median duration of response (DOR) was 9.26 months (95% CI: 2.3 to not estimable).

Five TNBC patients were treated for more than 32 weeks, with one patient reaching a duration of 73 weeks. This case study has been selected for the "Chinese Clinical Case Achievement Database" (with the PFS of this case being 16 months as of September 28, 2023).

According to data released by the International Agency for Research on Cancer (IARC) in 2020, a division of the World Health Organization (WHO), breast cancer is the most prevalent malignant tumor in women worldwide. TNBC comprises about 10-15% of all breast cancer cases. TNBC refers to breast cancer tissue that tests negative for estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor-2 (HER2). It represents an aggressive subtype of breast cancer with a poor prognosis².

Professor Binghe Xu said, "The research of breast cancer treatment has progressed significantly in the past decade. However, compared to other subtypes of breast cancer, treatment options for drug-resistant TNBC remain relatively limited, highlighting significant clinical unmet needs. In this study, we observed an ORR of 35.7% in patients with drug-resistant metastatic TNBC who received treatment. Five TNBC patients undergoing treatment for more than 32 weeks, including one patient reaching a duration of 73 weeks. These findings supported further investigation of this combination therapy."

¹Hyuna Sung, Jacques Ferlay, Rebecca L. Siegel, et al. Global Cancer Statistics 2020_ GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

²KWANG-AI WON,CHARLES SPRUCK Triple‑negative breast cancer therapy Current and future perspectives (Review)

Selected for presentation at AACR 2024

“The upregulation of AKT pathway activity is associated with resistance to standard treatments in many cancers. AKT inhibitors reduce AKT activity of tumor cells, restoring sensitivity to prior treatments.” said Dr. Yue Yong, CMO of Laekna. “Leveraging our comprehensive understanding and expertise in AKT pathway activation, Laekna has initiated five combination therapy clinical trials, targeting breast cancer, prostate cancer, ovarian cancer, PD-1 resistant cervical cancer and endometrial cancer. Currently, the Phase III pivotal trial of afuresertib plus fulvestrant in patients with HR+/HER2- LA/mBC has been initiated. We are confident that afuresertib has the potential to be an effective treatment for drug-resistant breast cancer to benefit a significant number of patients."

The Annual Meeting of AACR is set for April 5 to 10, 2024 at the San Diego Convention Center, California, USA. It is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine.

—End—

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About Afuresertib

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.

About LAE005

LAE005 is a high-affinity, ligand-blocking, humanized anti-PD-L1 IgG4 antibody. In the pre-clinical and clinical studies, LAE005 demonstrated its strong binding avidity to PD-L1 and compelling anti-tumor activities.

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 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 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 code2105.HK. 

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

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