Laekna Therapeutics Announces Dosing of First Patients in the U.S. and China in Phase Ib/III Study of Afuresertib in Combination with Fulvestrant in HR+/HER2- Breast Cancer

SHANGHAI and WARREN,N.J.,May 26,2022 --Laekna Therapeutics,a clinical-stage biotechnology companydeveloping innovative medicines to treat cancer and liver diseases,today announced that two first patients have been dosed in the U.S. and China,respectively,in a Phase Ib/III clinical trial that evaluates the efficacy and safety of afuresertib in combination with fulvestrant,an estrogen receptor antagonist,in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who failed after 1-2 lines of CDK4/6 inhibitors,endocrine,or chemotherapy treatments.

Afuresertib is an investigational AKT kinase inhibitor with global exclusive rights obtained from Novartis. The lead investigator of the study in China is Professor Binghe Xu,Academician of the Chinese Academy of Engineering and Director of the National Clinical Research Center for Cancer,while Professor Peter Kaufman,Lead Medical Oncologist from The University of Vermont Medical Center,is the lead investigator of the study in the U.S. Patient enrollment has begun simultaneously at the Piedmont Cancer Institute in the U.S. and Tianjin Medical University Cancer Institute & Hospital in China,and will soon begin in several other sites.Laekna will initiate a Phase III global pivotal trial after afuresertib plus fulvestrant shows a manageable safety profile in the Phase Ib study.

Breast cancer is the most common cancer among women worldwide. About 62% and 68% of all breast cancer patients in China and the U.S. are HR+/HER2- respectively[1,2]. "Although most patients with this type of breast cancer initially benefit from endocrine ±CDK4/6 inhibitors and/or chemotherapy as first- or second-line treatment,resistance occurs in most patients in about two years. I look forward to the results from the clinical study of afuresertib in combination with fulvestrant,which could offer a new treatment option for treatment-resistant breast cancer," said Professor Xu.

"Our team has been working closely with the investigators to overcome obstacles and dose the first patients both in the U.S. and China according to schedule,which demonstrated Laekna's robust global clinical development capabilities," said Dr. Yong Yue,Chief Medical Officer of Laekna Therapeutics. "Our next step is to expedite simultaneous global development of afuresertib plus fulvestrant to bring hope to patients who have developed treatment resistance."

For more information,please visit http://www.laekna.com

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

2 SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Bethesda,MD. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.htm

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