June 2, 2024 — The investigators meeting of AFFIRM-205, a phase III clinical trial led by Academician Binghe Xu, MD, PhD, the Cancer Hospital Chinese Academy of Medical Sciences, to evaluate the efficacy and safety of afuresertib (LAE002) plus fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer has been held in Beijing on June 23, 2024.

More than 50 breast cancer specialists from 47 oncology clinical research centers across China reviewed the safety and efficacy data of our phase Ib study. The specialists also shared their insights on the protocol of our phase III clinical trial and the planned implementation strategy after in-depth discussions.

The latest data released by the International Agency for Research on Cancer (IARC) of the World Health Organization indicated that breast cancer ranked as the second most frequent cancer among women in China, with an estimated number of 357,161 new cases in 2022¹. Approximately 62% of breast cancer patients in China were found to be HR+/HER2. 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.

Laekna’s (2105.HK) afuresertib is one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally. As shown in the results of our phase Ib study, the median PFS of afuresertib plus fulvestrant was 7.3 months, which significantly improved from the PFS data of 3-4 months for fulvestrant monotherapy².

“Results of the phase Ib study have demonstrated promising efficacy of AKT inhibitors to treat breast cancer, especially in patients of HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN alterations”, said Academician Binghe Xu. The first patient has been enrolled in AFFIRM-205 by the end of May at the Cancer Hospital Chinese Academy of Medical Sciences. The participants of the investigators meeting are feeling excited to the coming results of AFFIRM-205.

As of June 30, enrollment for the AFFIRM-205 study had been progressing smoothly across 47 centers nationwide, with 10 breast cancer patients screened so far.

—End—

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

² N Engl J Med 2023;388:2058-70.

Contact Us

IR  ir@laekna.com

Media  communication@laekna.com

Corporate and Business Development  BD@laekna.com

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/

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.