On January 4, 2022- Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. jointly reported that the IND application for the pivotal clinical trial (KN026-CSP-001) of the anti-HER2 bispecific antibody KN026 combined with chemotherapy was approved by the Center for Drug Evaluation (CDE) of NMPA (Press release, Alphamab, JAN 4, 2022, View Source [SID1234611313]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
KN026-CSP-001 is a randomized, multi-center, phase II/III clinical study to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastroesophageal junction cancer) who have failed first-line treatment, with Professor Jianming Xu from the Chinese People’s Liberation Army General Hospital as principal investigator.
GC/GEJ is one of the common malignant tumors and there are more than 1 million new cases each year in the world. The incidence of gastric cancer is high in China, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of GC/GEJ worldwide. Gastric cancer in China is characterized by low diagnosis rate of early gastric cancer, high proportion of metastatic stage (>80%) and low 5-year survival rate (about 35.1%), which seriously threatens the life and health of people. HER2 is overexpressed in many tumors, including about 15-20% in gastric cancer. HER2 overexpression is related to tumor aggressiveness and poor prognosis. With the development of targeted therapies, HER2-positive advanced gastric cancer patients have achieved better efficacy compared to traditional chemotherapy when treated with a combination of targeted drugs. However, for patients with HER2-positive gastric cancer who have progressed or recurred after first-line treatment, there is no effective drug approved in China, and there is a huge unmet clinical need.
KN026 is a HER2 bispecific antibody developed by Alphamab Oncology. Data from the Phase II clinical study of KN026, published at ASCO (Free ASCO Whitepaper) in 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, pretreated either 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%. The approval of the clinical trial application is a touchstone for the cooperation between Alphamab Oncology and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China. We hope to see more positive data from the study, and bring hope to patients with advanced gastric cancer who are in urgent need of new treatment options.
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, Macau and Taiwan).