August 7, 2024 — Laekna, Inc.  (2105.HK) today announced that the Group will present the data of a Phase I/II clinical trial (clinicaltrials.gov, NCT05383482) of a triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel) in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy at the annual global meeting of the International Gynecologic Cancer Society (“IGCS”)

Positive response has been observed among the advanced cervical and endometrial cancer patients who have been treated multiple lines of SOCs including PD-1 drugs and/ or chemotherapy in the Phase I/II study.

“Two clinical studies in combination therapies with LAE002 (afuresertib), our core product, for the treatment of breast cancer and cervical cancer/endometrial cancer have been accepted for presentation in the 2024 European Society for Medical Oncology (ESMO) and the International Society of Gynecologic Oncology respectively. It demonstrated the promising anti-tumor efficacy and well-tolerated safety profile of LAE002 (afuresertib) in cancer treatments. ”said Mr. Keith Chau, Chief Financial Officer of Laekna . “We are pleased to have made significant progress in this triple-combination therapy (afuresertib plus Sintilimab plus nab-paclitaxel). Laekna pursues to actively collaborate with industry leaders to address the major unmet needs of patients”.

Mr. Keith Chau added, “We also made substantial progress in development of our ACTRII portfolio. LAE102 is our internally discovered antibody against ActRIIA. We commenced Phase I clinical study and dosed the first subject in June 2024. Laekna is active in discussions with global industry leaders to explore strategic collaborations in ActRII portfolio to accelerate the development and commercialization of LAE102.”

-  End –

About IGCS

The annual global meeting of IGCS will be held in Dublin, Ireland from October 16 to 18, 2024. IGCS is a platform for exchanging insights, sharing research findings, and discussing best practices. Since 1985, the International Gynecologic Cancer Society (IGCS) has been uniting the globe in the fight against gynecologic cancer by contributing to the prevention, treatment and study of gynecologic cancer, as well as improvement in the quality of life among women suffering from gynecologic cancer throughout the world.

About LAE002 (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.

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 endocrine therapy  with CDK4/6 inhibitors, a big unmet medical need with huge market potential. Laekna has commenced 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-LA/mBC in May 2024 which was ahead of our planned schedule. Laekna will continue to carry on our ongoing clinical trials in the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/PD-L1 drug-resistant solid tumors to address unmet medical needs.

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.

Contact us

IR  ir@laekna.com

Media communication@laekna.com

Business Development bd@laekna.com