Laekna Therapeutics Announces First Patient Enrolled in the Clinical Trial of Innovative Combination Therapy for Triple-Negative Breast Cancer

-  The 5-year survival rate of patients with advanced triple-negative breast cancer is only 12%, lowest among all breast cancers. The treatment options for triple-negative breast cancer are extremely limited due to lack of therapeutic targets

-  Compared with approved treatments, the combination of the AKT inhibitor and PD-L1 monoclonal antibody has the potential to improve the patient’s survival and their quality of life

-   Laekna Therapeutics is one of global leaders in exploring the therapeutic roles of the novel AKT inhibitor in multiple cancer indications

Shanghai, China/New Jersey, the United States, June 23, 2021 – Laekna Therapeutics Shanghai Co., Ltd. announced that it has enrolled the first patient on June 11, for the Phase I/II clinical trial that evaluates the combination therapy of the potential first-in-class AKT inhibitor and PD-L1 monoclonal antibody in patients with locally advanced/metastatic triple-negative breast cancer.

The clinical trial was granted the investigational new drug (IND) approval by the National Medical Products Administration (NMPA) of China in late 2020. The Phase I/II clinical trial covers 20 medical centers and plans to enroll up to 101 patients. As the Principal Investigator, Professor Xu Binghe, the Cancer Hospital of the Chinese Academy of Medical Sciences, said that the new target of the combination therapy in this clinical trial will bring hope to patients with triple-negative breast cancer.

Laekna Therapeutics has obtained exclusive global rights of the two drugs used in this combination. Afuresertib (LAE002) is an oral novel pan-AKT kinase inhibitor, and has demonstrated strong anti-cancer efficacy and tolerable safety in more than 400 patients from multiple global clinical trials. LAE005 is a new anti-PD-L1 humanized monoclonal antibody. LAE005 monotherapy has demonstrated preliminary results from the Phase I clinical trial by proving the safety and anti-cancer efficacy in multiple solid tumors, including triple-negative breast cancer.

Triple-negative breast cancer is a sub-type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and HER2 protein, and has the highest mortality rate among all subtypes of breast cancer. According to data released by the World Health Organization in 2018, triple-negative breast cancer accounted for 13% of new breast cancer cases worldwide with a trend in women of younger ages. Patients had a bigger risk of local recurrence and distant metastasis in the early stage, and the 5-year survival rate of those in advanced stage was only 12%[i]. Due to the lack of therapeutic targets, only a limited number of treatment options are available today for patients with triple-negative breast cancer clinically. Chemotherapy as the standard-of-care has unsatisfactory efficacy/safety and seriously affects the prognosis and quality of life of patients. In China, no targeted therapy has yet to be approved for this sub-type of breast cancer, therefore, developing a novel effective therapy for triple-negative breast cancer is a great unmet medical need.

“Patients with triple-negative breast cancer has a low survival rate and urgently need a more effective therapy. Compared with existing treatments, AKT inhibitor and PD-L1 monoclonal antibody work synergistically to inhibit cancer growth or kill cancer cells, with the potential to significantly improve the progression-free survival and overall survival,” said Dr. Yue Yong, Chief Medical Officer of Laekna Therapeutics. “We’d like to appreciate the contributions made bythe study investigator, clinical trial staff and patients enrolled in the study. We will continue to work tirelessly with all partners to provide the study results as early as possible to bring a new hope for patients with such devastating form of cancer.”

“The study of the combination therapy is one of the six ongoing clinical programs at Laekna Therapeutics. As one of global leaders in the AKT inhibitor development competing with the global pharmaceutical companies, we have launched multiple early- and late-phase pivotal registration studies. We are on the path to develop a potential first-in-class AKT inhibitor in China,” said Dr. Chris Lu, Founder and Chief Executive Officer of Laekna Therapeutics. Besides obtaining the global rights for several innovative drugs previously developed from Novartis, Laekna Therapeutics is also stepping up its efforts to build its proprietary research and development platform with more than 10 molecules as the pre-clinical drug candidates are in various discovery stages. Laekna’s pre-clinical development programs focus on ground-breaking innovative therapies in the field of Oncology and Liver Diseases and several pre-clinical drug candidates are about to enter clinical development.

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About Afuresertib（LAE002）

Afuresertib (LAE002) is an oral, small molecule pan-AKT kinase inhibitor. It has been in over 10 phase 1/2 clinical trials, including ovarian cancer, gastric cancer, multiple myeloma, and melanoma. These studies have clearly demonstrated that afuresertib has strong anti-cancer activities and tolerable safety profile in cancer patients.

AKT (a serine/threonine-protein kinase) recently has become a hotspot in the medical field since its discovery, and it plays an important role in regulating various cell functions, such as metabolism, survival, proliferation, tissue invasion, chemotherapy resistance, etc. PTEN deletion, and AKT/PIK3CA alteration may lead to excessive activation of the AKT signaling pathways, which is one of the key drivers for cancer growth. The increased activation of the AKT signaling pathway is particularly common in recurrent ovarian cancer, breast cancer, and prostate cancer.

. A global multi-center phase II registered clinical trial (PROFECTA-II) in China and the United States has been fully launched, and it is the world’s first registration-directed clinical trial where a pan-AKT kinase inhibitor is used to treat platinum resistant ovarian cancer. Laekna expects that the endpoints will be reached in China and the US simultaneously in 2022, and plans to submit new drug applications to China’s NMPA and the US FDA at the end of next year.

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is an emerging innovative pharma company based in China’s “Zhangjiang Pharma Valley” and New Jersey in the US, focusing on developing new ground-breaking innovative therapies to treat cancer and liver diseases.

Laekna Therapeutics is adopting a two-pronged strategy in new drug development. On the one hand, it continues to enrich its portfolio by introducing global new drugs with the clinical Proof of Concept. The company has obtained the global exclusive rights of four new drug candidates from Novartis. On the other hand, the company’s self-developed innovative drugs will soon enter clinical development stages.

Laekna has set up a team of top global pharmaceutical talent and acquired key technologies. Its leadership team members have over 20 years of experience in new drug development in China and the US, with an exceptional track record in R&D, new drug approvals and commercialization. Laekna is committed to a science-based, innovation-driven approach to create a leading clinical research and development pipeline, and develop first-in-class and best-in-class innovative drugs. It has been developing an international leading platform for new drug research and development to benefit patients.

The detail Laekna Therapeutics information can be found from the website: http://www.leaknatp.com

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