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As of January 15, 2021, 9 patients received at least one tumor assessment and entered the efficacy analysis data set, and 17 patients entered the safety analysis data set
.
The objective response rate (ORR) was 55.
6%, and the disease control rate (DCR) was 88.
9%
.
The updated data of this phase II clinical trial will be released at an academic conference this year; the phase III clinical study of KN046 combined with chemotherapy for the first-line treatment of pancreatic cancer will be launched in 2021
.
Suzhou, China, June 5, 2021 - Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that KN046 combined with albumin paclitaxel/gemcitabine for the first-line treatment of pancreatic ductal adenocarcinoma (PDAC) Phase II clinical study data (study Number: KN046-IST-04), which will be announced at the 2021 American Society of Clinical Oncology (ASCO 2021) annual meeting in the form of a poster
.
Pancreatic cancer is recognized as the "king of cancer" in the medical field.
About 90% of pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC), which is difficult to detect, progresses quickly, and has a high fatality rate.
The patients have no obvious symptoms in the early stage.
There is no indication for surgery, there is a lack of effective treatment methods in clinic, and there is a huge unmet clinical need
.
KN046-IST-04 is a phase II clinical study initiated by the investigator in China.
As of January 15, 2021, the preliminary results of the study have been presented at the ASCO 2021 online annual meeting on June 4, US Eastern Time.
The poster form is announced, and the electronic poster can be viewed on the company's website
.
Poster topic: Efficacy and safety of KN046 combined with albumin paclitaxel/gemcitabine as the first-line treatment of unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) Poster number: 198868 Session title: Gastrointestinal tumors-Gastroesophagus, Pancreas, Liver and Gallbladder First Author: Professor Jin Gang, the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) This is a phase II clinical study in China, which is included in the group of unresectable locally advanced or metastases confirmed by histology or cytology Patients with pancreatic ductal adenocarcinoma (PDAC) have an ECOG PS of 0-1 and have not received systemic treatment for unresectable locally advanced or metastatic disease
.
Patients received KN046 combined with albumin paclitaxel and gemcitabine for 4-6 cycles, and then received KN046 (5mpk, Q2W) maintenance treatment
.
Tumor evaluation was performed according to RECIST 1.
1 every 8 weeks
.
The primary research endpoint is the objective response rate (ORR) assessed by the investigator, and the secondary research endpoints are disease control rate (DCR), duration of response (DOR), time to disease progression (TTP), progression-free survival (PFS), total Lifetime (OS) and safety
.
As of January 15, 2021, a total of 17 patients were enrolled, the median age (range) was 56 (36-75) years, 9 patients had an ECOG PS score of 1, and 7 patients had liver metastases at baseline
.
The median exposure time of KN046 was 9.
5 weeks
.
Among them, 9 patients received at least one tumor assessment and entered the efficacy analysis data set, and 17 patients entered the safety analysis data set
.
Partial response (PR) was 55.
6% (5/9), stable disease (SD) was 33.
3% (3/9); objective response rate (ORR) was 55.
6% (95% CI: 21.
2-86.
3), disease control rate (DCR) was 88.
9% (95% CI: 51.
8-99.
7)
.
The incidence of treatment-related adverse events (TRAE) was 64.
7%, and grade 3 and above accounted for 29.
4%
.
The most common (≥10%) TRAEs are: elevated alanine aminotransferase (n=5, 29.
4%), nausea (n=3, 17.
6%), skin rash (n=3, 17.
6%), aspartame Elevated acid transaminase (n=2, 11.
8%), diarrhea (n=2, 11.
8%), hyperphosphatemia (n=2, 11.
8%), fever (n=2, 11.
8%), vomiting (n= 2, 11.
8%)
.
The main investigator of the clinical trial, Professor Jin Gang from the First Affiliated Hospital of Naval Military Medical University, said: “Pancreatic cancer is one of the common malignant tumors of the digestive system in China, with a high degree of malignancy and a very poor prognosis
.
From
2015 to 2020, China New cases of pancreatic cancer increased by about 31.
6%, and death cases increased by about 43.
5%.
New cases and deaths of patients were almost the same, and an effective treatment plan was urgently needed
.
At present, domestic and foreign guidelines recommend albumin paclitaxel combined with gemcitabine (AG plan) as The first-line treatment of advanced PDAC, but the curative effect is limited and chemotherapy resistance is unavoidable
.
The synergistic effect of immune checkpoint inhibitors combined with chemotherapy may be a new direction for the treatment of pancreatic cancer
.
We are very happy to see the PD-L1/CTLA-4 dual The anti-KN046 combined with AG regimen achieved an objective response rate of 55.
6% in patients with advanced pancreatic ductal adenocarcinoma, which is more than double the historical ORR of AG regimen chemotherapy
.
We look forward to continuing to explore its great value in subsequent clinical studies.
Advanced pancreatic cancer patients bring new hope for treatment
.
" Dr.
Xu Ting, Chairman and President of Corning Jerry, said: "We are very pleased to see that KN046 has demonstrated exciting clinical data in pancreatic cancer research, which once again validates this innovation.
The great potential of medicine
.
Thanks to the experts who initiated and participated in this study, and the patients who participated in the clinical trial together
.
The updated data of this clinical study, including the evaluable results of more patients, will be released at an academic conference held this year; based on these data, we plan to initiate a phase III clinical study of KN046 combined with chemotherapy for first-line pancreatic cancer this year to further evaluate KN046 Aiming at the curative effect of pancreatic cancer, we will bring urgently needed treatment programs to more patients as soon as possible
.
"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 enriched in The tumor microenvironment with high PD-L1 expression and the elimination of Tregs that inhibit tumor immunity
.
KN046 has been launched in Australia and China to cover more than 10 types of non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, thymic cancer, liver cancer, pancreatic cancer, etc.
There are nearly 20 clinical trials in different stages of cancer, and the trial results show that patients have the advantage of survival benefit
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter the phase II clinical trial in the United States, and in September 2020 KN046 month awarded for the treatment of thymic epithelial tumors orphan status
.
currently KN046 four pivotal registration clinical trials are underway
.
AboutNingjie Rui biopharmaceutical focused on the development, production and commercialization of innovative anticancer drugs
.
2019 December 12, the company listed on Hong Kong stock Exchange, stock code: 9966
.
Corning Jerry biopharmaceuticals have found the whole industry chain, R & D and manufacturing platform in the 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
.
.
The objective response rate (ORR) was 55.
6%, and the disease control rate (DCR) was 88.
9%
.
The updated data of this phase II clinical trial will be released at an academic conference this year; the phase III clinical study of KN046 combined with chemotherapy for the first-line treatment of pancreatic cancer will be launched in 2021
.
Suzhou, China, June 5, 2021 - Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that KN046 combined with albumin paclitaxel/gemcitabine for the first-line treatment of pancreatic ductal adenocarcinoma (PDAC) Phase II clinical study data (study Number: KN046-IST-04), which will be announced at the 2021 American Society of Clinical Oncology (ASCO 2021) annual meeting in the form of a poster
.
Pancreatic cancer is recognized as the "king of cancer" in the medical field.
About 90% of pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC), which is difficult to detect, progresses quickly, and has a high fatality rate.
The patients have no obvious symptoms in the early stage.
There is no indication for surgery, there is a lack of effective treatment methods in clinic, and there is a huge unmet clinical need
.
KN046-IST-04 is a phase II clinical study initiated by the investigator in China.
As of January 15, 2021, the preliminary results of the study have been presented at the ASCO 2021 online annual meeting on June 4, US Eastern Time.
The poster form is announced, and the electronic poster can be viewed on the company's website
.
Poster topic: Efficacy and safety of KN046 combined with albumin paclitaxel/gemcitabine as the first-line treatment of unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) Poster number: 198868 Session title: Gastrointestinal tumors-Gastroesophagus, Pancreas, Liver and Gallbladder First Author: Professor Jin Gang, the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) This is a phase II clinical study in China, which is included in the group of unresectable locally advanced or metastases confirmed by histology or cytology Patients with pancreatic ductal adenocarcinoma (PDAC) have an ECOG PS of 0-1 and have not received systemic treatment for unresectable locally advanced or metastatic disease
.
Patients received KN046 combined with albumin paclitaxel and gemcitabine for 4-6 cycles, and then received KN046 (5mpk, Q2W) maintenance treatment
.
Tumor evaluation was performed according to RECIST 1.
1 every 8 weeks
.
The primary research endpoint is the objective response rate (ORR) assessed by the investigator, and the secondary research endpoints are disease control rate (DCR), duration of response (DOR), time to disease progression (TTP), progression-free survival (PFS), total Lifetime (OS) and safety
.
As of January 15, 2021, a total of 17 patients were enrolled, the median age (range) was 56 (36-75) years, 9 patients had an ECOG PS score of 1, and 7 patients had liver metastases at baseline
.
The median exposure time of KN046 was 9.
5 weeks
.
Among them, 9 patients received at least one tumor assessment and entered the efficacy analysis data set, and 17 patients entered the safety analysis data set
.
Partial response (PR) was 55.
6% (5/9), stable disease (SD) was 33.
3% (3/9); objective response rate (ORR) was 55.
6% (95% CI: 21.
2-86.
3), disease control rate (DCR) was 88.
9% (95% CI: 51.
8-99.
7)
.
The incidence of treatment-related adverse events (TRAE) was 64.
7%, and grade 3 and above accounted for 29.
4%
.
The most common (≥10%) TRAEs are: elevated alanine aminotransferase (n=5, 29.
4%), nausea (n=3, 17.
6%), skin rash (n=3, 17.
6%), aspartame Elevated acid transaminase (n=2, 11.
8%), diarrhea (n=2, 11.
8%), hyperphosphatemia (n=2, 11.
8%), fever (n=2, 11.
8%), vomiting (n= 2, 11.
8%)
.
The main investigator of the clinical trial, Professor Jin Gang from the First Affiliated Hospital of Naval Military Medical University, said: “Pancreatic cancer is one of the common malignant tumors of the digestive system in China, with a high degree of malignancy and a very poor prognosis
.
From
2015 to 2020, China New cases of pancreatic cancer increased by about 31.
6%, and death cases increased by about 43.
5%.
New cases and deaths of patients were almost the same, and an effective treatment plan was urgently needed
.
At present, domestic and foreign guidelines recommend albumin paclitaxel combined with gemcitabine (AG plan) as The first-line treatment of advanced PDAC, but the curative effect is limited and chemotherapy resistance is unavoidable
.
The synergistic effect of immune checkpoint inhibitors combined with chemotherapy may be a new direction for the treatment of pancreatic cancer
.
We are very happy to see the PD-L1/CTLA-4 dual The anti-KN046 combined with AG regimen achieved an objective response rate of 55.
6% in patients with advanced pancreatic ductal adenocarcinoma, which is more than double the historical ORR of AG regimen chemotherapy
.
We look forward to continuing to explore its great value in subsequent clinical studies.
Advanced pancreatic cancer patients bring new hope for treatment
.
" Dr.
Xu Ting, Chairman and President of Corning Jerry, said: "We are very pleased to see that KN046 has demonstrated exciting clinical data in pancreatic cancer research, which once again validates this innovation.
The great potential of medicine
.
Thanks to the experts who initiated and participated in this study, and the patients who participated in the clinical trial together
.
The updated data of this clinical study, including the evaluable results of more patients, will be released at an academic conference held this year; based on these data, we plan to initiate a phase III clinical study of KN046 combined with chemotherapy for first-line pancreatic cancer this year to further evaluate KN046 Aiming at the curative effect of pancreatic cancer, we will bring urgently needed treatment programs to more patients as soon as possible
.
"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 enriched in The tumor microenvironment with high PD-L1 expression and the elimination of Tregs that inhibit tumor immunity
.
KN046 has been launched in Australia and China to cover more than 10 types of non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, thymic cancer, liver cancer, pancreatic cancer, etc.
There are nearly 20 clinical trials in different stages of cancer, and the trial results show that patients have the advantage of survival benefit
.
Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter the phase II clinical trial in the United States, and in September 2020 KN046 month awarded for the treatment of thymic epithelial tumors orphan status
.
currently KN046 four pivotal registration clinical trials are underway
.
AboutNingjie Rui biopharmaceutical focused on the development, production and commercialization of innovative anticancer drugs
.
2019 December 12, the company listed on Hong Kong stock Exchange, stock code: 9966
.
Corning Jerry biopharmaceuticals have found the whole industry chain, R & D and manufacturing platform in the 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
.
