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One year has passed since the concept of "one molecule a year" was put forward at the JPMorgan Chase Medical and Health Annual Conference last year.
What kind of new thinking did Kewang bring to this conference? Extended reading Kewang: One Molecule a Year | JPM 2021 Dr.
Ji Xiaohui, the co-founder and CEO of Kewang Medicine, as a speaker, introduced Kewang's distinctive positioning: through the development of a new generation, differentiation, and curative effect "Global new" or "best-in-class" tumor immunotherapy, turning "cold tumors" into "hot tumors", for those about 70% who do not respond to PD-1/PD-L1 inhibitors, or develop resistance of cancer patients worldwide with new treatment strategies
.
Kewang also has end-to-end R&D capabilities, as well as strong trust and support from investors
.
When introducing the team of scientists, Dr.
Ji Xiaohui said: "Our scientists are full of enthusiasm for making new drugs
.
They develop new therapeutic drugs on differentiated targets to meet the urgent needs of patients
.
" The difference between "cold tumor" and "hot tumor" Human immune cells are the most common type of normal cells that coexist with cancer cells.
If there are many immune cells around the cancer cells, the tumor is a hot tumor, otherwise, it is a cold tumor
.
There are many factors in cold tumors that suppress the immune response, so that immune cells are either eliminated or inhibited from attacking tumor cells
.
Turning Cold Tumors into Hot Tumors and Activating the Immune System "Turning a cold tumor into a hot tumor is not a new concept, but Kewan has given it new meaning
,
" Ji Xiaohui said
.
So, how to improve the microenvironment of cold tumors and make immune cells more active? Specifically, Dr.
Hongtao Lu, Chief Scientific Officer of Kewang Pharmaceuticals, said in an interview with Guanlan Pharmaceuticals that in the view of Kewang Pharmaceuticals, innate immune regulation is the next breakthrough in the development of anti-tumor immunotherapy
.
Especially in the process of turning "cold tumors" into "hot tumors", innate immunity plays a key role
.
Using a Dual Approach to Regulate the Tumor Microenvironment We want to focus on innate immunity and tumor microenvironment regulation using a dual approach: one is to deactivate immunosuppressive factors in the tumor microenvironment, and the other is to reactivate exhausted T cells
.
These two distinct R&D strategies make Kewan unique
.
Kewan has two R&D strategies, one is to deactivate immunosuppressive factors in the tumor microenvironment, and the other is to reactivate exhausted T cells
.
In the first mode, its next-generation anti-angiogenic dual-antibody drug ES104 inhibited Treg cells and protected Teff cells
.
In addition, ES002, ES014 including inhibitory adenosine, ES014 is also an inhibitory transforming growth factor beta, and ES004 and ES028 developed based on the "don't eat me" signaling pathway in macrophages
.
The typical "representative" in reactivating exhausted T cell function is ES101
.
This is a tetravalent bispecific antibody containing 4 binding domains, two of which target PD-L1 and the other two target 4-1BB
.
ES101 can conditionally activate 4-1BB in the tumor microenvironment while effectively and persistently blocking PD-L1, thereby enhancing the anti-tumor killing function of immune cells
.
Beautiful pipeline of research products Kewang's pipeline of products under research includes 9 new immunotherapies, and 4 products ES104, ES002, ES101 and ES102 have entered the clinical research stage
.
Kewang's product pipeline and research progress.
Among them, ES104, ES101, and ES102 have Greater China rights, and 6 products have global rights
.
Cowan has conducted extensive research on the innate immune system with encouraging results
.
These varieties are developed based on the concept of turning "cold tumors" into "hot tumors"
.
Among them, self-developed "global new" innovative drugs, including SIPRα double antibody and CD39 double antibody, have not yet been approved for the same target drugs, and only a few companies are developing drugs
.
Kewan's four mainstay products, ES104: is a bispecific antibody that simultaneously blocks the VEGF and DLL4 signaling pathways that play important roles in angiogenesis and tumor vascularization
.
ES104 as a monotherapy has observed sustained PR responses in patients with tumors that have undergone multi-line therapy and are resistant to existing approved VEGF therapy, which is its biggest highlight.
The indications are colorectal cancer, biliary tract tumor, gastric cancer , ovarian and esophageal cancer
.
The preliminary data of ES104ES104 Phase II/a clinical trial enrolled 17 patients with unresectable advanced, metastatic or recurrent biliary tract tumors who have received one or two systemic therapy in the recommended dose (RP2D) Phase II/a clinical trial In the test, the CBR of ES104 reached 100%, and the ORR reached 29%
.
"For patients with recurrent biliary tract tumors, it is a great news
.
" Ji Xiaohui said
.
ES002: It is a monoclonal antibody that blocks the ATPase activity of CD39 protein
.
Blocking the ATPase activity of CD39 on the one hand reduces the production of adenosine, maintains the ATP level in the tumor microenvironment, and further promotes the activation of T cells by DC cells
.
On the other hand, blocking the activity of CD39 can reduce the immunosuppressive function of regulatory T cells and reactivate exhausted T cells, which has a strong potential for antitumor activity
.
ES002 In preclinical studies, ES002 demonstrated a favorable safety profile, and intraperitoneal administration of ES002 demonstrated significant antitumor activity in two cell line-derived xenograft (CDX) models
.
ES002 is currently undergoing Phase I human clinical trials in the United States, and China's IND filing was also implicitly approved in November last year for non-small cell lung cancer, colorectal cancer, gastric cancer and pancreatic ductal adenocarcinoma
.
ES014: Its highlight is that it is the world's first bispecific antibody targeting both CD39 and TGFβ.
It is a bifunctional molecule designed by fusing the TGF-β receptor to an antibody targeting CD39, which not only inhibits immunosuppressive gonads The production of glycosides promotes the production of immunostimulatory ATP, and can also create a "hot" tumor microenvironment that is favorable for immune responses by neutralizing the immunosuppressive factor TGF-β
.
Studies have shown that ES014 effectively blocks the differentiation of Treg cells and promotes the survival and function of effector T cells
.
Currently, ES014 will submit an IND application in the United States in the first quarter of 2022 for the indications of pancreatic ductal adenocarcinoma, liver cancer and pancreatic ductal adenocarcinoma
.
ES014 targets both CD39 and TGFβ ES004: ES004 is an innovative drug independently developed based on the "don't eat me" signaling pathway in macrophages.
It is an antibody targeting the CD47-SIRPα signaling pathway
.
ES004 targets SIRPα antibody, blocks the "don't eat me" signal of CD47-SIRPα, and then stimulates the phagocytic function of macrophages, triggers an adaptive immune response, and activates the killing ability of T cells
.
ES004 plans to submit an IND application for the drug in the United States in the first quarter of 2023, and IND and clinical studies in China will also be launched as soon as possible
.
Indications are head and neck squamous cell carcinoma, colorectal cancer, gastric cancer and breast cancer
.
ES004 Kewan created BiME (Bispecific Macrophage Engager), the world's first macrophage activation coupling platform, designed to simultaneously bind to inhibitory receptors (such as SIRPα) on macrophages and specific antigens on tumor cells, Direct activation of macrophages to destroy tumor cells
.
SIRPα antibodies block the "don't eat me" signal, while antibodies to tumor-specific antigens are linked through Fc receptors to send "eat me" signals
.
Together, they can greatly activate the phagocytosis of macrophages to directly kill tumor cells
.
The macrophage tumor cross-linking platform BiME talked about the future market.
Ji Xiaohui said that the incidence of cancer in China will reach 4.
6 million in 2020, and the Chinese oncology drug market is expected to reach US$100 billion in 2023
.
While benefiting from the huge unmet clinical needs in China, Chinese biotech companies are uniquely positioned to drive global innovation in immuno-oncology
.
In the future, Kewang will join hands with clinical research experts in China and the United States to conduct international multi-center clinical trials, maintain smooth exchanges with drug regulatory agencies in China and the United States, and benefit patients around the world with scientific innovation
.
Looking back and looking forward to the past year, Ji Xiaohui summed up several major events, one is to complete the C round of financing with an amount of 105 million US dollars, the other is to promote various clinical research progress; the third is to carry out ES104 with TRIGR/ The exclusive licensing transaction in China; Fourth, its process development and pilot production base in Suzhou was officially launched on May 18 last year, and on the last day of 2021, Kewang held an area of about 4,000 square meters in Shanghai.
The housewarming celebration of the Innovation Center
.
In the past 5 years, Ji Xiaohui and his colleagues have devoted a lot of enthusiasm and hard work to Kewang.
When an R&D client interviewed him in 2018, he asked Xiaohui whether he wanted Kewang to be a biotechnology company or a biotech company.
When the pharmaceutical factory covers the whole chain from R&D to production and sales, he uses the metaphor of sending his children (products) to (transferring) "Harvard University" (pharmaceutical factory) for further study
.
Extended reading Kewang: Taking biology as the lead, focusing on science, creating hope | Jianghu However, at this conference, he said, "The company has grown to nearly 200 people, and we have developed systematically according to the management model of a large pharmaceutical factory.
, while maintaining the scientific truth-seeking and exploratory spirit of biotechnology companies, as well as flexible operation methods, and have a key promotion plan for each product
.
At present, we are making every effort to promote important candidate molecules into the clinic, and realize the research and development of one molecule a year.
Goal
.
” “In 2021, which has experienced challenges such as the ravages of the new crown epidemic, the tightening of capital market policies, serious industry influx, and the cold biomedical capital market, I still believe that the future of the biomedical industry is bright
.
The
country has borders, and there is no disease.
National borders
.
We insist on biology-led scientific innovation to create good news for cancer patients around the world
.
" Dr.
Ji Xiaohui said in an interview with R&D guests after the JPM conference
.
What kind of new thinking did Kewang bring to this conference? Extended reading Kewang: One Molecule a Year | JPM 2021 Dr.
Ji Xiaohui, the co-founder and CEO of Kewang Medicine, as a speaker, introduced Kewang's distinctive positioning: through the development of a new generation, differentiation, and curative effect "Global new" or "best-in-class" tumor immunotherapy, turning "cold tumors" into "hot tumors", for those about 70% who do not respond to PD-1/PD-L1 inhibitors, or develop resistance of cancer patients worldwide with new treatment strategies
.
Kewang also has end-to-end R&D capabilities, as well as strong trust and support from investors
.
When introducing the team of scientists, Dr.
Ji Xiaohui said: "Our scientists are full of enthusiasm for making new drugs
.
They develop new therapeutic drugs on differentiated targets to meet the urgent needs of patients
.
" The difference between "cold tumor" and "hot tumor" Human immune cells are the most common type of normal cells that coexist with cancer cells.
If there are many immune cells around the cancer cells, the tumor is a hot tumor, otherwise, it is a cold tumor
.
There are many factors in cold tumors that suppress the immune response, so that immune cells are either eliminated or inhibited from attacking tumor cells
.
Turning Cold Tumors into Hot Tumors and Activating the Immune System "Turning a cold tumor into a hot tumor is not a new concept, but Kewan has given it new meaning
,
" Ji Xiaohui said
.
So, how to improve the microenvironment of cold tumors and make immune cells more active? Specifically, Dr.
Hongtao Lu, Chief Scientific Officer of Kewang Pharmaceuticals, said in an interview with Guanlan Pharmaceuticals that in the view of Kewang Pharmaceuticals, innate immune regulation is the next breakthrough in the development of anti-tumor immunotherapy
.
Especially in the process of turning "cold tumors" into "hot tumors", innate immunity plays a key role
.
Using a Dual Approach to Regulate the Tumor Microenvironment We want to focus on innate immunity and tumor microenvironment regulation using a dual approach: one is to deactivate immunosuppressive factors in the tumor microenvironment, and the other is to reactivate exhausted T cells
.
These two distinct R&D strategies make Kewan unique
.
Kewan has two R&D strategies, one is to deactivate immunosuppressive factors in the tumor microenvironment, and the other is to reactivate exhausted T cells
.
In the first mode, its next-generation anti-angiogenic dual-antibody drug ES104 inhibited Treg cells and protected Teff cells
.
In addition, ES002, ES014 including inhibitory adenosine, ES014 is also an inhibitory transforming growth factor beta, and ES004 and ES028 developed based on the "don't eat me" signaling pathway in macrophages
.
The typical "representative" in reactivating exhausted T cell function is ES101
.
This is a tetravalent bispecific antibody containing 4 binding domains, two of which target PD-L1 and the other two target 4-1BB
.
ES101 can conditionally activate 4-1BB in the tumor microenvironment while effectively and persistently blocking PD-L1, thereby enhancing the anti-tumor killing function of immune cells
.
Beautiful pipeline of research products Kewang's pipeline of products under research includes 9 new immunotherapies, and 4 products ES104, ES002, ES101 and ES102 have entered the clinical research stage
.
Kewang's product pipeline and research progress.
Among them, ES104, ES101, and ES102 have Greater China rights, and 6 products have global rights
.
Cowan has conducted extensive research on the innate immune system with encouraging results
.
These varieties are developed based on the concept of turning "cold tumors" into "hot tumors"
.
Among them, self-developed "global new" innovative drugs, including SIPRα double antibody and CD39 double antibody, have not yet been approved for the same target drugs, and only a few companies are developing drugs
.
Kewan's four mainstay products, ES104: is a bispecific antibody that simultaneously blocks the VEGF and DLL4 signaling pathways that play important roles in angiogenesis and tumor vascularization
.
ES104 as a monotherapy has observed sustained PR responses in patients with tumors that have undergone multi-line therapy and are resistant to existing approved VEGF therapy, which is its biggest highlight.
The indications are colorectal cancer, biliary tract tumor, gastric cancer , ovarian and esophageal cancer
.
The preliminary data of ES104ES104 Phase II/a clinical trial enrolled 17 patients with unresectable advanced, metastatic or recurrent biliary tract tumors who have received one or two systemic therapy in the recommended dose (RP2D) Phase II/a clinical trial In the test, the CBR of ES104 reached 100%, and the ORR reached 29%
.
"For patients with recurrent biliary tract tumors, it is a great news
.
" Ji Xiaohui said
.
ES002: It is a monoclonal antibody that blocks the ATPase activity of CD39 protein
.
Blocking the ATPase activity of CD39 on the one hand reduces the production of adenosine, maintains the ATP level in the tumor microenvironment, and further promotes the activation of T cells by DC cells
.
On the other hand, blocking the activity of CD39 can reduce the immunosuppressive function of regulatory T cells and reactivate exhausted T cells, which has a strong potential for antitumor activity
.
ES002 In preclinical studies, ES002 demonstrated a favorable safety profile, and intraperitoneal administration of ES002 demonstrated significant antitumor activity in two cell line-derived xenograft (CDX) models
.
ES002 is currently undergoing Phase I human clinical trials in the United States, and China's IND filing was also implicitly approved in November last year for non-small cell lung cancer, colorectal cancer, gastric cancer and pancreatic ductal adenocarcinoma
.
ES014: Its highlight is that it is the world's first bispecific antibody targeting both CD39 and TGFβ.
It is a bifunctional molecule designed by fusing the TGF-β receptor to an antibody targeting CD39, which not only inhibits immunosuppressive gonads The production of glycosides promotes the production of immunostimulatory ATP, and can also create a "hot" tumor microenvironment that is favorable for immune responses by neutralizing the immunosuppressive factor TGF-β
.
Studies have shown that ES014 effectively blocks the differentiation of Treg cells and promotes the survival and function of effector T cells
.
Currently, ES014 will submit an IND application in the United States in the first quarter of 2022 for the indications of pancreatic ductal adenocarcinoma, liver cancer and pancreatic ductal adenocarcinoma
.
ES014 targets both CD39 and TGFβ ES004: ES004 is an innovative drug independently developed based on the "don't eat me" signaling pathway in macrophages.
It is an antibody targeting the CD47-SIRPα signaling pathway
.
ES004 targets SIRPα antibody, blocks the "don't eat me" signal of CD47-SIRPα, and then stimulates the phagocytic function of macrophages, triggers an adaptive immune response, and activates the killing ability of T cells
.
ES004 plans to submit an IND application for the drug in the United States in the first quarter of 2023, and IND and clinical studies in China will also be launched as soon as possible
.
Indications are head and neck squamous cell carcinoma, colorectal cancer, gastric cancer and breast cancer
.
ES004 Kewan created BiME (Bispecific Macrophage Engager), the world's first macrophage activation coupling platform, designed to simultaneously bind to inhibitory receptors (such as SIRPα) on macrophages and specific antigens on tumor cells, Direct activation of macrophages to destroy tumor cells
.
SIRPα antibodies block the "don't eat me" signal, while antibodies to tumor-specific antigens are linked through Fc receptors to send "eat me" signals
.
Together, they can greatly activate the phagocytosis of macrophages to directly kill tumor cells
.
The macrophage tumor cross-linking platform BiME talked about the future market.
Ji Xiaohui said that the incidence of cancer in China will reach 4.
6 million in 2020, and the Chinese oncology drug market is expected to reach US$100 billion in 2023
.
While benefiting from the huge unmet clinical needs in China, Chinese biotech companies are uniquely positioned to drive global innovation in immuno-oncology
.
In the future, Kewang will join hands with clinical research experts in China and the United States to conduct international multi-center clinical trials, maintain smooth exchanges with drug regulatory agencies in China and the United States, and benefit patients around the world with scientific innovation
.
Looking back and looking forward to the past year, Ji Xiaohui summed up several major events, one is to complete the C round of financing with an amount of 105 million US dollars, the other is to promote various clinical research progress; the third is to carry out ES104 with TRIGR/ The exclusive licensing transaction in China; Fourth, its process development and pilot production base in Suzhou was officially launched on May 18 last year, and on the last day of 2021, Kewang held an area of about 4,000 square meters in Shanghai.
The housewarming celebration of the Innovation Center
.
In the past 5 years, Ji Xiaohui and his colleagues have devoted a lot of enthusiasm and hard work to Kewang.
When an R&D client interviewed him in 2018, he asked Xiaohui whether he wanted Kewang to be a biotechnology company or a biotech company.
When the pharmaceutical factory covers the whole chain from R&D to production and sales, he uses the metaphor of sending his children (products) to (transferring) "Harvard University" (pharmaceutical factory) for further study
.
Extended reading Kewang: Taking biology as the lead, focusing on science, creating hope | Jianghu However, at this conference, he said, "The company has grown to nearly 200 people, and we have developed systematically according to the management model of a large pharmaceutical factory.
, while maintaining the scientific truth-seeking and exploratory spirit of biotechnology companies, as well as flexible operation methods, and have a key promotion plan for each product
.
At present, we are making every effort to promote important candidate molecules into the clinic, and realize the research and development of one molecule a year.
Goal
.
” “In 2021, which has experienced challenges such as the ravages of the new crown epidemic, the tightening of capital market policies, serious industry influx, and the cold biomedical capital market, I still believe that the future of the biomedical industry is bright
.
The
country has borders, and there is no disease.
National borders
.
We insist on biology-led scientific innovation to create good news for cancer patients around the world
.
" Dr.
Ji Xiaohui said in an interview with R&D guests after the JPM conference
.
