HER2 double anti-KN026 combined with chemotherapy for gastric cancer registration clinical trial completed the first patient dosing

Corning & Jereh Biopharmaceuticals (stock code: 9966.
HK) and CSPC (stock code: 1093.
HK) jointly announced the registration of HER2 dual anti-KN026 combined with chemotherapy for the treatment of HER2-positive gastric cancer (including gastroesophageal junction adenocarcinoma) Clinical study (study number: KN026-001) completed the first patient dosing
.
KN026-001 is a randomized, multicenter, phase II/III clinical study evaluating the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastroesophageal junction adenocarcinoma) who have failed first-line therapy
.
Gastric cancer and gastroesophageal junction adenocarcinoma are one of the common malignant tumors.
There are more than 1 million new cases of gastric cancer every year in the world.
China is a country with a high incidence of gastric cancer, with about 410,000 new cases and 294,000 deaths each year.
Death cases account for more than 40% of gastric cancer cases worldwide
.
The characteristics of gastric cancer in China are the low detection rate of early gastric cancer and the low 5-year survival rate (about 35.
1%), which seriously threatens the life and health of Chinese people
.
HER2 is overexpressed in many tumors, among which about 15-20% of gastric cancers.
HER2 overexpression is related to tumor aggressiveness and poor prognosis.
With the development of targeted therapy, HER2-positive advanced gastric cancer is treated with targeted drugs in combination.
Afterwards, it achieved better curative effect than traditional chemotherapy regimens
.
However, for patients with HER2-positive gastric cancer who have progressed or relapsed after first-line therapy in China, there is no effective drug targeting HER2, and there is a huge unmet clinical need
.
About KN026 KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can simultaneously bind to two non-overlapping epitopes of HER2, resulting in HER2 signal blocking, better than Trastuzumab or Pertuzumab alone can achieve the effect of combined use of Trastuzumab and Pertuzumab.
If it shows higher affinity, it has excellent efficacy in HER2-positive tumor cell lines.
tumor suppressor effect
.
At the same time, KN026 also has inhibitory effects on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.
KN026 has been approved by China's National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) in 2018, and is currently conducting a number of Phase I/II clinical trials in China, and is also advancing Phase I clinical trials in the United States
.
Phase I clinical trial results showed that KN026 was well tolerated and safe, and still showed significant antitumor activity in patients with HER2-positive breast cancer that progressed after multi-line anti-HER2 therapy
.
In August 2021, Corning Jereh and Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Biotechnology"), a wholly-owned subsidiary of CSPC, signed a license agreement for the development and commercialization of KN026 in mainland China
.
According to the terms of the agreement, Jinmante Bio will obtain the exclusive development and commercialization license rights of KN026 in mainland China (excluding Hong Kong, Macau and Taiwan) for breast cancer and gastric cancer indications
.