IND Application for Phase III Clinical Study of Anti-HER2 Bispecific Antibody KN026 was Officially Accepted by CDE

Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK) jointly announced IND application for a phase III clinical study of recombinant humanized anti-HER2 bispecific antibody KN026 (KN026-306) was officially accepted by Center for Drug Evaluation (CDE), and will initiate a pivotal clinical study of KN026 combined with chemotherapy in advanced gastric and gastroesophageal junction cancer (GC/GEJ) patients who progressed after first-line standard chemotherapy.

GC/GEJ is the fifth most common malignant tumors and the third cancer causing death worldwide. According to the latest global cancer burden data published by the World Health Organization in 2020, there are 480,000 new cases and 370,000 deaths from gastric cancer in China each year, accounting for nearly half cases of the world respectively with 12%-13% HER2 positive rate.

Data from the Phase II clinical study of KN026 were published at the ASCO 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, either pretreated with or without anti HER2 treatments. In patients with high expression, the ORR was 55.6% and the DCR was 72.2%, and the 9-month PFS rate was 60.4%. Among patients receiving prior-HER2 treatment, the ORR was 44.4%, and the DCR was 66.7%.

This is the second pivotal clinical study of KN026 after the first one combined with KN046 for the treatment of HER2-positive solid tumors. It is also the first phase III clinical study of KN026. This application demonstrated the seamless transition and cooperation between companies after the deal announced. We expect the collaboration will accelerate the clinical development and commercialization of KN026 and better treatment options to Chinese GC/GEJ patients in no time.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China).

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong, S.A.R., China Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.

About CSPC

CPSC, listed on the Hong Kong, S.A.R., China Stock Exchange (stock code: 1093), was selected as a constituent stock of the Hang Sang Index in 2018 and was the first constituent stock in the pharmaceutical sector since the launch of the index. Currently, it is one of constituent stocks of Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland Healthcare Index, Hang Seng Stock Connect Index, Hang Seng (Hong Kong, S.A.R., China-listed) 100 Index and Hang Seng China Enterprise Index. As of the date of this announcement, CPSC has total assets of more than RMB30billion and more than 23,000 employees. CSPC has a national top research and development team with research and development bases in Shijiazhuang, Shanghai, Beijing and the United States, focusing on the discovery, research and development of small molecule targeted drugs, nanodrugs, monoclonal antibody drugs, bispecific antibody drugs, antibody-drug conjugates，mRNA vaccines, small nucleic acid drugs and biological drugs in the immune field.

Source: Alphamab Oncology