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As of May 8, 2021, a total of 44 patients have been enrolled, who have received at least one KN026 and/or KN046 treatment, and 36 patients have received at least one tumor assessment.
Among them, the objective response rate (ORR) of HER2-positive patients is 51.
9%.
The duration of response (DOR) was 11.
2 months; the objective response rate (ORR) was 71.
4% for first-line patients who did not undergo systemic treatment; and 18.
2% of patients had TRAE ≥ grade 3
.
September 17, 2021, Suzhou, China-Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that KN026 combined with KN046 for the treatment of HER2-positive/mutated/low-expressing malignant gastrointestinal tumors (GI) Phase Ib clinical study data (Study No.
: KN046-IST-02), which will be announced at the 2021 European Society of Medical Oncology (ESMO 2021) annual meeting in the form of a poster
.
KN026 is a bispecific antibody that targets different extracellular domains II (pertuzumab binding site) and IV (trastuzumab binding site) of HER2.
KN046 recognizes PD-L1 at the same time.
And CTLA-4 two target bispecific antibodies
.
KN046-IST-02 is a phase Ib clinical study initiated by investigators in China to explore the safety and effectiveness of KN026 combined with KN046 (no chemotherapy regimen) in the treatment of HER2-positive/mutation/low expression advanced GI, as of May 2021 The preliminary research results on August 8 (mainly the effectiveness data for HER2 positive GI and the safety data of KN026 and KN046) will be announced in the form of a poster at the ESMO 2021 annual meeting on September 16.
The electronic poster is available on the company's website www.
Check it out on alphamabonc.
com
.
Poster topic: Preliminary efficacy and safety of KN026 combined with KN046 in the treatment of patients with HER2-positive gastrointestinal tumors Poster number: 1377P First author: Gong Jifang, Beijing Cancer Hospital This is a phase Ib clinical study in China and was included in the group These are patients with metastatic or locally advanced gastrointestinal tumors with HER2 positive/mutation/low expression confirmed by histology or cytology, regardless of whether they have received systemic treatment in the past
.
This study includes a dose expansion phase and a dose escalation phase.
Patients in the dose escalation phase receive four dose groups of KN026 combined with KN046 treatment.
The investigator can expand patients into the selected dose group
.
Tumor evaluations were performed on the enrolled patients according to RECIST 1.
1 every 8 weeks
.
The primary endpoint of the dose escalation phase is dose-limiting toxicity (DLT), and the primary endpoint of the dose extension phase is the objective response rate (ORR), duration of response (DOR) and safety
.
As of May 8, 2021, a total of 44 patients were enrolled, the median age (range) was 56 (29,74) years, 39 patients had an ECOG PS score of 1, 34 patients were HER2 positive, of which 24 patients were HER2 positive Among GC/GEJ patients, 10 patients had previously received trastuzumab therapy
.
90.
9% of the patients in this study had at least one study drug-related adverse event (TRAE) during the treatment period, and the common ones were anemia (38.
6%), infusion-related reactions (36.
4%), elevated AST (27.
3%), and diarrhea (27.
3) %), the ALT increased (25.
0%), rash (20.
5%) and the like
.
18.
2% of patients had at least one TRAE ≥3 grade, the most common being anemia (4.
5%)
.
Among the 44 patients, 36 patients underwent at least one tumor assessment, the ORR was 38.
9%, and the median DOR was 11.
2 months
.
Among the 27 HER2-positive patients who underwent tumor evaluation, the ORR was 51.
9% and the median DOR was 11.
2 months.
Among the 21 GC/GEJ patients, 7 had not received systemic treatment before, the ORR was 71.
4%, and 14 had previous After receiving systemic treatment, the ORR was 42.
9%, and 10 patients had previously received trastuzumab treatment, and the ORR was 40.
0%
.
The main investigator of the clinical trial, Professor Lin Shen from Peking University Cancer Hospital, said: "Currently, chemotherapy is still the main treatment for advanced gastrointestinal tumors, but chemotherapy has serious side effects and is prone to drug resistance
.
We are very pleased to see that.
KN026 combined with KN046, a combination of chemotherapy-free treatment, has shown good therapeutic effects in HER2-positive advanced gastrointestinal tumors, especially for first-line HER2-positive gastric cancer/gastroesophageal junction cancer patients, with an objective remission rate of up to 71.
4%
.
Currently HER2 positive The first-line standard treatment for gastric cancer/gastroesophageal junction cancer is trastuzumab combined with chemotherapy, with an objective response rate of only 40% to 50%
.
We look forward to further exploring this de-chemotherapy combination in HER2-positive gastrointestinal tumors in follow-up clinical studies The great value of the Chinese Academy of Sciences brings new hope for the treatment of patients with advanced gastrointestinal tumors
.
"About KN026KN026 is an anti-HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can bind to two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than trastuzumab or pertuzumab alone, achieving the effect of trastuzumab and pertuzumab combined , If it exhibits higher affinity, it has a superior tumor suppressor effect in HER2-positive tumor cell lines
.
At the same time, KN026 also has an inhibitory effect on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.
KN026 has been approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) in 2018.
A number of Phase I/II clinical trials are currently underway in China, and phase I clinical trials are being promoted in the United States.
.
The results of phase I clinical trials showed that KN026 is well tolerated and safe, and still exhibits significant anti-tumor activity in HER2-positive breast cancer patients who have progressed after multi-line anti-HER2 treatment
.
About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes: the fusion of CTLA-4 and PD-L1 single domain antibodies with different mechanisms; it can be targeted to enrich PD -The tumor microenvironment with high expression of L1 and the elimination of Treg that inhibit tumor immunity
.
KN046 has carried out nearly 20 clinical trials of different stages covering more than 10 types of tumors including non-small cell lung cancer, thymic cancer, pancreatic cancer, liver cancer, esophageal squamous cell carcinoma, triple negative breast cancer, etc.
in Australia and China.
The test results show that patients have survived.
Benefits
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter Phase II clinical trials in the United States, and granted KN046 the orphan drug designation for the treatment of thymic epithelial tumors in September 2020
.
Four key registered clinical trials of KN046 are currently in progress
.
About Corning Jereh Biopharmaceuticals Corning Jereh Biopharmaceuticals focuses on the research and development, production and commercialization of innovative anti-tumor drugs
.
On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange, stock code: 9966
.
Corning Jereh Biopharmaceuticals has a discovery, R&D, and manufacturing platform for the entire industry chain in bispecific antibody and protein engineering
.
The company's product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly double antibodies, and a Covid-19 multifunctional antibody, four of which are in China, the United States, Japan, and Australia It is in clinical phase I~III
.
The marketing application of Envolimab Injection (KN035) has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review
.
The company has a number of technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that meet the cGMP standards of China, the United States and the European Union, and have passed a complete quality system including multiple audits of the European Union QP.
.
The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
.
Welcome to the company website
.
Among them, the objective response rate (ORR) of HER2-positive patients is 51.
9%.
The duration of response (DOR) was 11.
2 months; the objective response rate (ORR) was 71.
4% for first-line patients who did not undergo systemic treatment; and 18.
2% of patients had TRAE ≥ grade 3
.
September 17, 2021, Suzhou, China-Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that KN026 combined with KN046 for the treatment of HER2-positive/mutated/low-expressing malignant gastrointestinal tumors (GI) Phase Ib clinical study data (Study No.
: KN046-IST-02), which will be announced at the 2021 European Society of Medical Oncology (ESMO 2021) annual meeting in the form of a poster
.
KN026 is a bispecific antibody that targets different extracellular domains II (pertuzumab binding site) and IV (trastuzumab binding site) of HER2.
KN046 recognizes PD-L1 at the same time.
And CTLA-4 two target bispecific antibodies
.
KN046-IST-02 is a phase Ib clinical study initiated by investigators in China to explore the safety and effectiveness of KN026 combined with KN046 (no chemotherapy regimen) in the treatment of HER2-positive/mutation/low expression advanced GI, as of May 2021 The preliminary research results on August 8 (mainly the effectiveness data for HER2 positive GI and the safety data of KN026 and KN046) will be announced in the form of a poster at the ESMO 2021 annual meeting on September 16.
The electronic poster is available on the company's website www.
Check it out on alphamabonc.
com
.
Poster topic: Preliminary efficacy and safety of KN026 combined with KN046 in the treatment of patients with HER2-positive gastrointestinal tumors Poster number: 1377P First author: Gong Jifang, Beijing Cancer Hospital This is a phase Ib clinical study in China and was included in the group These are patients with metastatic or locally advanced gastrointestinal tumors with HER2 positive/mutation/low expression confirmed by histology or cytology, regardless of whether they have received systemic treatment in the past
.
This study includes a dose expansion phase and a dose escalation phase.
Patients in the dose escalation phase receive four dose groups of KN026 combined with KN046 treatment.
The investigator can expand patients into the selected dose group
.
Tumor evaluations were performed on the enrolled patients according to RECIST 1.
1 every 8 weeks
.
The primary endpoint of the dose escalation phase is dose-limiting toxicity (DLT), and the primary endpoint of the dose extension phase is the objective response rate (ORR), duration of response (DOR) and safety
.
As of May 8, 2021, a total of 44 patients were enrolled, the median age (range) was 56 (29,74) years, 39 patients had an ECOG PS score of 1, 34 patients were HER2 positive, of which 24 patients were HER2 positive Among GC/GEJ patients, 10 patients had previously received trastuzumab therapy
.
90.
9% of the patients in this study had at least one study drug-related adverse event (TRAE) during the treatment period, and the common ones were anemia (38.
6%), infusion-related reactions (36.
4%), elevated AST (27.
3%), and diarrhea (27.
3) %), the ALT increased (25.
0%), rash (20.
5%) and the like
.
18.
2% of patients had at least one TRAE ≥3 grade, the most common being anemia (4.
5%)
.
Among the 44 patients, 36 patients underwent at least one tumor assessment, the ORR was 38.
9%, and the median DOR was 11.
2 months
.
Among the 27 HER2-positive patients who underwent tumor evaluation, the ORR was 51.
9% and the median DOR was 11.
2 months.
Among the 21 GC/GEJ patients, 7 had not received systemic treatment before, the ORR was 71.
4%, and 14 had previous After receiving systemic treatment, the ORR was 42.
9%, and 10 patients had previously received trastuzumab treatment, and the ORR was 40.
0%
.
The main investigator of the clinical trial, Professor Lin Shen from Peking University Cancer Hospital, said: "Currently, chemotherapy is still the main treatment for advanced gastrointestinal tumors, but chemotherapy has serious side effects and is prone to drug resistance
.
We are very pleased to see that.
KN026 combined with KN046, a combination of chemotherapy-free treatment, has shown good therapeutic effects in HER2-positive advanced gastrointestinal tumors, especially for first-line HER2-positive gastric cancer/gastroesophageal junction cancer patients, with an objective remission rate of up to 71.
4%
.
Currently HER2 positive The first-line standard treatment for gastric cancer/gastroesophageal junction cancer is trastuzumab combined with chemotherapy, with an objective response rate of only 40% to 50%
.
We look forward to further exploring this de-chemotherapy combination in HER2-positive gastrointestinal tumors in follow-up clinical studies The great value of the Chinese Academy of Sciences brings new hope for the treatment of patients with advanced gastrointestinal tumors
.
"About KN026KN026 is an anti-HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can bind to two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than trastuzumab or pertuzumab alone, achieving the effect of trastuzumab and pertuzumab combined , If it exhibits higher affinity, it has a superior tumor suppressor effect in HER2-positive tumor cell lines
.
At the same time, KN026 also has an inhibitory effect on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.
KN026 has been approved by the National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) in 2018.
A number of Phase I/II clinical trials are currently underway in China, and phase I clinical trials are being promoted in the United States.
.
The results of phase I clinical trials showed that KN026 is well tolerated and safe, and still exhibits significant anti-tumor activity in HER2-positive breast cancer patients who have progressed after multi-line anti-HER2 treatment
.
About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes: the fusion of CTLA-4 and PD-L1 single domain antibodies with different mechanisms; it can be targeted to enrich PD -The tumor microenvironment with high expression of L1 and the elimination of Treg that inhibit tumor immunity
.
KN046 has carried out nearly 20 clinical trials of different stages covering more than 10 types of tumors including non-small cell lung cancer, thymic cancer, pancreatic cancer, liver cancer, esophageal squamous cell carcinoma, triple negative breast cancer, etc.
in Australia and China.
The test results show that patients have survived.
Benefits
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter Phase II clinical trials in the United States, and granted KN046 the orphan drug designation for the treatment of thymic epithelial tumors in September 2020
.
Four key registered clinical trials of KN046 are currently in progress
.
About Corning Jereh Biopharmaceuticals Corning Jereh Biopharmaceuticals focuses on the research and development, production and commercialization of innovative anti-tumor drugs
.
On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange, stock code: 9966
.
Corning Jereh Biopharmaceuticals has a discovery, R&D, and manufacturing platform for the entire industry chain in bispecific antibody and protein engineering
.
The company's product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly double antibodies, and a Covid-19 multifunctional antibody, four of which are in China, the United States, Japan, and Australia It is in clinical phase I~III
.
The marketing application of Envolimab Injection (KN035) has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review
.
The company has a number of technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that meet the cGMP standards of China, the United States and the European Union, and have passed a complete quality system including multiple audits of the European Union QP.
.
The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
.
Welcome to the company website
.
