On 18 Sept 2021, Akeso, Inc. (9926.HK, “the Company”) announces that at the European Society for Medical Oncology Congress of 2021 (ESMO 2021) on 16-21 September 2021, a phase II study of new anti-tumor drug Penpulimab monoclonal injection (trade name: 安尼可®) for treatment of metastatic nasopharyngeal carcinoma (NPC) with progression after two or more lines of chemotherapy published in the form of poster. The e-Poster can be accessed on the website of Akeso at http://www.mxcysc.com. Penpulimab is in-house developed by the Company and in collaboration with Chia Tai Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharmaceutical Limited (stock code: 1177.HK), for subsequent development and commercialization.
Research title: A phase II study of the anti-programmed cell death-1 (PD-1) antibody penpulimab in patients with metastatic nasopharyngeal carcinoma (NPC) who had progressed after two or more lines of chemotherapy: Updated results
Abstract number: 909P
First author: Prof. Chen Xiaozhong, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Corresponding author: Prof. Hu Chaosu, Fudan University Cancer Hospital
Penpulimab has demonstrated encouraging anti-tumor activity and favorable safety profile in NPC patients with disease progression after ≥ 2 prior lines of chemotherapy. This e-Poster reported the updated data after an additional follow-up period for about 5 months.
In this phase II clinical research of Penpulimab for treatment of NPC that has progressed after two or more lines of chemotherapy, 130 patients were enrolled in total, of which 111 patients met the definition of primary efficacy population assessed by IRRC, with an objective response rate (ORR) of 29.7% and 1 patient achieved complete response (CR). The disease control rate (DCR) was 49.5%. As of 3 February 2021, the median follow-up time was 14.7 months. Median progression-free survival (PFS) was 3.65 months and median overall survival (OS) was 18.63 months, assessed by IRRC.
In terms of safety profile, the incidence of ≥ Grade 3 treatment related adverse events (TRAEs) was only 8.5%.
These updated results have demonstrated that Penpulimab has impressive efficacy and favorable safety profile in the treatment of patients with metastatic NPC who failed second-line (platinum-containing chemotherapy) and higher chemotherapy.
Currently, Penpulimab monoclonal antibody (安尼可®) has submitted Biologics License Application (BLA) to the Food and Drug Administration of the United States (FDA) for third-line treatment of metastatic NPC. Penpulimab monoclonal antibody for third-line treatment of metastatic NPC has also submitted new drug application (NDA) in China and was accepted by the NMPA, and had obtained earlier breakthrough therapy designation and fast track designation from the FDA.
Information about 安尼可® (Penpulimab Antibody Injection)
安尼可® (Penpulimab antibody injection) is a new PD-1 monoclonal antibody with IgG1 subtype and Fc segment modification, which is structurally stable and less prone to aggregation. Antibody-dependent cell-mediated cytotoxicity (ADCC), acoustic doppler current profiler (ADCP) and complement dependent cytotoxicity (CDC) is avoided entirely, and antibody-drug conjugate reaction (ADCR) is lessened. Crystal structure analysis reveals a unique PD-1 binding epitope with a slower dissociation rate from PD-1 for durable blockade of PD-1/PD-L1 binding. This differentiation from other PD-1 products on the market may lead to a better efficacy and safety profile for the Penpulimab antibody.
Information about Akeso, Inc.
Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. The Company’s vision is to become a global leading biopharmaceutical company through research and development (‘‘R&D’’) of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.
Information about Sino Biopharm
Sino Biopharm is a leading R&D-based pharmaceutical group in China, with business covering the entire industry chain including various pharmaceutical R&D platforms, intelligent production and strong sales system. Its products include various kinds of biopharmaceutical and chemical medicines, and have gained a competitive foothold in various therapeutic categories with promising potentials, including tumors, liver diseases, cardiocerebral diseases, analgesic medicines, respiratory system medicines and orthopedic diseases.
Information about Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (‘‘Chia Tai Tianqing’’)
Chia Tai Tianqing is an innovative pharmaceutical company with integrated pharmaceutical R&D, manufacturing and commercialization capabilities. With more than 14,000 employees, it is a leading pharmaceutical company in China in the fields of oncology, liver diseases and respiratory diseases. It ranked 15th place in the list of the top 100 pharmaceutical companies in China in 2020, and has been awarded as the best industrial company in China in terms of pharmaceutical R&D product pipeline in 2021.
Chia Tai Tianqing takes technological innovation as its important strategy for sustainable development, making unremitting efforts to actively research and develop innovative and high- quality pharmaceutical products, Chia Tai Tianqing has formed its production in the six core therapeutic sectors, including oncology, liver diseases, respiratory diseases, infection, endocrine and cardiocerebral. Chia Tai Tianqing has invested 10% to 12% of its annual sales revenue in research and development. It has 196 ongoing research projects, including 82 new drugs. It has undertaken over 30 major national specialized projects, and has applied for over 1,500 patents in China, including over 500 patents announced in China, and over 200 patents announced overseas.
