May 30, 2024 — Laekna, Inc. (2105.HK) announced that the first patient has been enrolled in the phase III clinical trial AFFIRM-205 in China for LAE002 (afuresertib, an oral AKT inhibitor) plus fulvestrant in patients with PIK3CA/AKT1/PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer.

The Phase III Clinical Trial AFFIRM-205 is a multi-center, randomized, double-blind, placebo-controlled pivotal study led by Academician Binghe Xu, MD, PhD, the Cancer Hospital Chinese Academy of Medical Science, which is conducted in forty-seven sites in China to further assess the anti-tumor efficacy and safety of the combination therapy. 

Promising anti-cancer efficacy demonstrated in Ib study

The results of the Phase Ib study in the combination therapy with 20 patients from U.S. and China has shown promising anti-cancer efficacy with a well-tolerated safety profile. The data of this study have been presented during a poster spotlight session at the 2023 San Antonio Breast Cancer Symposium (SABCS) in December 2023（https://www.laekna.com/new/345.html）.

- Among the total patient population, the confirmed ORR was 30% (95% CI, 11.9, 54.3), the disease control rate (DCR) was 80%, the median PFS was 7.3 months (95% CI, 3.7, NE).

- Among the 11 patients with specific biomarker alterations (PIK3CA/AKT1/PTEN), the confirmed objective response rate was 45.4% (95% CI, 16.7, 76.6), the disease control rate was 82%, and the median PFS was 7.3 months (95% CI, 3.6, 8.2).

Laekna has enrolled 11 additional subjects in this Phase Ib study and further verified the promising anti-cancer efficacy with a well-tolerated safety profile indicated in the earlier stage of the study. The company plans to present the clinical data of all enrolled patients and the patients with positive biomarker in this Phase Ib study in a scientific conference in second half of 2024.

Novel Therapies Needed for the Treatment of Hormone Receptor-positive Breast Cancer Patients

“As shown in the results of Phase Ib study, the median PFS of afuresertib plus fulvestrant was 7.3 months. This is a significant improvement compared to the PFS data of 3-4 months for fulvestrant monotherapy. This combination therapy also demonstrated a favorable safety profile and the potential efficacy of AKT inhibitors to treat breast cancer, especially patients with PIK3CA/AKT1/PTEN alterations and HR+/HER2- locally advanced or metastatic breast cancer”, said Academician Binghe Xu, the lead investigator of the study. “While therapies for breast cancer are increasing, the treatment of drug resistance remains one of the clinical challenges. I am feeling excited about the coming Phase III study of afuresertib in 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 deaths. The IARC also reported that breast cancer ranked second among women in China, with an estimated number of 357,161 new cases in 2022.

Approximately 69% of breast cancer patients in the United States were found to be HR+/HER2-, and the proportion of this subtype among Chinese patients were approximately 62%. 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.

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1.N Engl J Med 2023;388:2058-70.

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

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

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

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

About afuresertib

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.

With the promising efficacy data from our afuresertib Phase Ib study for HR+/HER2- breast cancer, which was presented in SABCS 2023, Laekna has initiated the Phase III pivotal study AFFIRM-205. We also continue to develop our clinical trials 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. In several clinical trials, the combination of afuresertib with other therapeutics exhibits favorable efficacy results.

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/

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