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Suzhou, China, November 23, 2022 – Corning Jerry Biopharmaceuticals (stock code: 9966.
HK) and CSPC Pharmaceutical Group (stock code: 1093.
HK) HK) jointly announced that the results of the phase II.
clinical study of HER2 dual antibody KN026 in the treatment of HER2-expressing advanced gastric cancer or gastroesophageal junction cancer were published
in the European Journal of Cancer (EJC, latest impact factor 10.
002), a well-known international journal in the field of oncology.
Professor Xu Jianming of the Fifth Medical Center of the General Hospital of the People's Liberation Army Chinese People's Liberation Army is the first author
of the paper.
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KN026 is a human epidermal growth factor receptor 2 (HER2) bispecific antibody that can act on different extracellular domains of HER2 II and IV.
The second-line treatment of KN026 for HER2 high-expression gastric cancer or gastroesophageal junction cancer improved the objective response rate.
KN026 has great potential to overcome trastuzumab resistance;
KN026 shows good safety
.
Gastric cancer and gastroesophageal junction adenocarcinoma is one of the common malignant tumors, the global annual new cases of gastric cancer more than 1 million, China is a country with a high incidence of gastric cancer, about 410,000 new cases and about 294,000 deaths every year, new cases and deaths account for more than
40% of the world's gastric cancer cases.
Gastric cancer in China is characterized by a low detection rate of early gastric cancer and a low 5-year survival rate (about 35.
1%), which seriously threatens the life and health
of Chinese people.
HER2 is overexpressed in many tumors, including about 15~20% of gastric cancer, HER2 overexpression is related to tumor aggressiveness and poor prognosis, so there is a huge unmet clinical need
in HER2-positive gastric cancer patients who progress or relapse after first-line treatment.
With the development of targeted therapy, HER2-positive advanced gastric cancer has a better efficacy
than traditional chemotherapy regimens after combined with targeted drug therapy.
This study is a single-arm, open-label, multicenter phase II.
clinical trial (KN026-202), enrolling patients with advanced gastric and gastric junction adenocarcinoma who have received at least first-line therapy in the past, and divided into two cohorts of HER2 high expression (cohort 1: IHC3+ or IHC2+ and ISH+) and low expression (cohort 2: IHC1+, or IHC2+ ISH-, or IHC 0 and ISH+) according to the results of central laboratory tests, aiming to evaluate the efficacy of KN026 in these two cohorts
。
A total of 45 patients were enrolled in this study, of which 27 patients with HER2 high expression received KN026 10mg/kg QW (5 cases), 20mg/kg Q2W (4 cases), and 30mg/kg Q3W (18 cases).
Nearly half (41%) of the 27 patients with HER2 expression had previously received ≥ line 2 therapy, and approximately 60% had previously received trastuzumab
。 Twenty-five patients underwent at least one tumor imaging evaluation, of which 14 were assessed as partial response (PR), 5 as stable disease (SD), 5 as disease progression (PD), and 1 without assessment, with an objective response rate (ORR) of 56% and long-term disease remission, with a median duration of response (DOR) of 9.
7 months and median PFS and OS of 8.
3 months and 16.
3 months
, respectively.
For 14 patients who progressed after previous treatment with trastuzumb, there was still an excellent treatment effect
.
All 45 patients were included in the safety analysis, and the common drug-related adverse events (TRAEs) were AST (27%), ALT (20%), rash (16%), anemia (16%) and infusion-related reactions (16%), mainly mild to moderate (CTCAE grade 1-2), only 4 patients (8.
9%) developed CTCAE grade 3 TRAE, and none patients developed CTCAE grade 4 and trae
that led to death.
The results showed that KN026 had excellent efficacy and good safety in
patients with gastric cancer with high expression of HER2/gastroesophageal junction cancer.
Currently, a registration clinical study of KN026 in combination with chemotherapy for the treatment of HER2-positive gastric cancer (including gastro-esophageal junction adenocarcinoma) is well underway to evaluate the efficacy and safety
of HER2-positive gastric cancer (including gas-esophageal junction adenocarcinoma) that has failed first-line therapy.
About KN026 KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights, which can bind to two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than the combination of trastuzumab and pertuzumab, such as showing higher affinity, and has a potent tumor suppressor effect in HER2-positive tumor cell lines
。 At the same time, KN026 also has inhibitory effect
on HER2 low-expression tumors and trastuzumab-resistant cell lines.
KN026 has been approved by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) in 2018, and is currently conducting a number of clinical trials in different stages in China and the United States, including breast cancer, gastric cancer/gastroesophageal junction cancer, etc.
, KN026 combined with chemotherapy and KN026 combined with KN046 no chemotherapy for gastric cancer
。 The trial results showed that KN026 had good efficacy and safety, and still showed significant antitumor activity
in patients with HER2-positive breast cancer who progressed after multi-line anti-HER2 therapy.
In August 2021, Corning Jerry signed a license agreement
for the development and commercialization of KN02 Chinese mainland 6 with Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Biotechnology"), a wholly-owned subsidiary of CSPC Pharmaceutical Group.
According to the terms of the agreement, Zimante Biotech will obtain the exclusive development and exclusive commercialization license of KN026 in Chinese mainland (excluding Hong Kong, Macau and Taiwan) for breast and gastric cancer indications
.
About Corning Jerry Corning Jerry Biopharmaceuticals was founded in 2015, the company with the mission of "making tumors a controllable and treatable disease", focusing on the research and development, production and commercialization
of innovative tumor macromolecule drugs.
On December 12, 2019, Corning Jereh Biopharmaceuticals was listed on the main board of the Hong Kong Stock Exchange with stock code: 9966.
HK
。
The company has brought together a professional R&D team led by top scientists who have returned to China, has a complete industrial chain from early research and development, process development, commercial production to clinical research of innovative drugs, and independently developed protein/antibody engineering, antibody screening and multi-functional antibody platforms
.
The company has declared 80 invention patents and authorized 26.
Corning Jerry's product pipeline consists of new anti-tumor drugs such as single-domain antibodies, bispecific antibodies and antibody conjugates with global competitiveness and differentiation, of which 2 varieties have been selected as the national "Major New Drug Creation" special project, and 3 varieties have been granted 4 orphan drug qualifications
by the US FDA.
The world's first subcutaneous injection of PD-L1 inhibitor Envolimab injection (R&D code: KN035, trade name: Envida ®) has been approved for marketing, and more than 30 clinical studies have been carried out in 6 varieties in China, the United States and Australia, of which 3 varieties and 8 studies have entered the key clinical research stage
in China and the United States.
"Kangda Patients, Ruiji Wanjia", Corning Jereh has always been guided by clinical value and patient needs, adhered to the strategy of internationalization and differentiation, and focused on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world
.
Welcome to the company's website: www.
alphamabonc.
com
About CSPC Pharmaceutical Group CSPC is a national innovative enterprise
with strong strength in the research and development, production and marketing of innovative drugs 。 Listed on the Hong Kong Stock Exchange (stock code: 1093), CSPC was selected as a constituent of the Hang Seng Index in 2018, making it the first pharmaceutical sector constituent
since its launch.
Currently, it is a
constituent of the Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Chinese mainland Healthcare Index, Hang Seng Hong Kong Stock Connect Index, Hang Seng China (Hong Kong) 100 Index and Hang Seng China Enterprises Index.
At present, CSPC has total assets of more than RMB 50 billion and more than 23,000 employees
.
CSPC has a top R&D team in China, with R&D bases in Shijiazhuang, Shanghai, Beijing and the United States, focusing on the discovery, research and development
of small molecule targeted drugs, nanomedicines, monoclonal antibody drugs, bispecific antibody drugs, antibody conjugate drugs, mRNA vaccines, oligonucleotide drugs and biological drugs in the field of immunity.
