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Recently (November 13th, 2021), CG Oncology disclosed the data of its dazzling Phase II clinical trial of its oncolytic virus drug CG0070 combined with K drug
.
The results of the test showed that among the 9 non-muscular invasive bladder cancer (NMIBC) patients who did not respond to BCG vaccine (BCG), all patients achieved complete remission (CR) at 3 months.
In addition, they reached 6 The CR rate of patients at the monthly evaluation node and the 9-month evaluation node also maintained 100%
.
NMIBC urgently needs new treatments Bladder cancer is one of the common malignant tumors of the urinary system (NMIBC accounts for 70% to 80% of bladder cancer), which has the characteristics of easy invasion, easy recurrence, easy drug resistance, and multicenter
.
In China, the incidence of bladder cancer has continued to increase year by year
.
According to Frost & Sullivan data, the number of new cases of bladder cancer in China in 2020 is 85,700, and it is expected to reach 101,100 and 117,600 in 2025 and 2030, respectively
.
The compound annual growth rate from 2020 to 2025 is 3.
4%, and the compound annual growth rate from 2025 to 2030 is 3.
1%
.
At present, the treatment methods for NMIBC are very limited.
The most commonly used treatment option is transurethral bladder tumor resection, and then according to the recurrence after surgery, intravesical perfusion treatment is adopted
.
Patients receiving this type of treatment will have up to 60% of recurrences, of which only more than 60% of patients can receive BCG (a live bacteria used to treat bladder cancer) treatment.
If BCG is ineffective/recurring, it is recommended The treatment plan is to completely remove the bladder (cystectomy), and the life after the bladder is removed is to carry a urine bag for life
.
For high-risk NMIBC patients with BCG ineffective/relapsed, new treatment options are urgently needed
.
Single-agent CR is significantly better than K drug CG0070 is an engineered adenovirus type 5 (Ad5) oncolytic virus drug developed by CG Oncology
.
Two coding genes are embedded in CG0070-tumor selective promoter E2F-1 and human granulocyte macrophage colony stimulating factor (GM-CSF) gene.
The modified Ad5 can selectively regulate defective Rb It replicates in tumor cells and finally lyses tumor cells
.
The ruptured cancer cells will further release tumor antigens and GM-CSF, stimulate the systemic anti-tumor immune response, and then reflect the dual tumor-killing effect of oncolytic viruses
.
Previously, CG Oncology has disclosed the dazzling data of the phase II clinical trial (BOND II) of a single drug of CG0070
.
The results showed that CG0070 showed a strong efficacy and good safety in highly malignant NMIBC patients who had failed BCG treatment
.
In the BOND2 trial, CG0070 achieved a significantly better CR than the K drug.
The 3-month CR rate of CG0070 was 46.
2% (40.
6% in the K drug group), and the 12-month CR rate was 29.
2% (the K drug group was 18.
7%)
.
The CR rate of combined K drugs is as high as 100%.
In addition to single drugs, CG0070 is also trying to use the combined effect of immune checkpoint inhibitors
.
Previously, CG Oncology, Merck, Roche, etc.
have reached a clinical cooperation development agreement to evaluate the potential synergistic efficacy of CG0070 and PD-1/PD-L1 inhibitors in tumors, to further improve the therapeutic effect of the drug and broaden the scope of indications
.
The clinical data of CG0070 combined with K drug released this time is also amazing
.
As of November 8, 2021, all patients who reached the 3-month assessment point (n=9) had achieved complete remission, and among the patients who reached the 6-month assessment point (n=6), all patients also maintained complete remission.
The complete remission rate of patients who reached the 9-month assessment point was still 100% (n=3)
.
CG-007 has shown extraordinary efficacy in high-risk NMIBC patients who do not respond to BCG, whether it is a single drug or a combination drug.
At present, this product has carried out a phase III clinical study for NMIBC in the United States, and it is expected to be brought to this type of patients as soon as possible.
A new and effective treatment plan
.
Domestic Lepu Biotech has the authorization for the development, manufacturing and commercialization of this product in China
.
A few days ago (November 12, 2021), Lepu Biotech has also obtained domestic clinical approval and has been approved to conduct clinical trials for non-muscle invasive bladder cancer
.
Lepu Biologics currently plans to initiate a clinical trial of CG0070 in combination with its core product HX008 for patients with advanced NMIBC.
The marketing application for new drugs for the treatment of melanoma and MSI-H/dMMR solid tumors has been accepted by the State Food and Drug Administration.
The listing application for MSI-H/dMMR solid tumors was officially included in the priority review by CDE on November 4, 2021 )
.
In addition to bladder cancer, Lepu Biotech also plans to further develop other indications such as colorectal cancer, liver cancer and breast cancer for CG0070
.
The editor concludes that as an important method in the field of tumor immunotherapy, the therapeutic potential of oncolytic virus drugs in malignant tumors and other diseases has been paid more and more attention by the scientific research community and the industry
.
According to incomplete statistics, there are about 180 oncolytic virus projects in the world.
Among them, Aglatimagene besadenovec and CG-0070 are progressing rapidly, and both are in the phase III clinical stage
.
(CG0070 is the world's first and only oncolytic virus product in the phase III clinical stage for the treatment of NMIBC).
Thanks to the advancement of genetic engineering technology, China is also increasingly active in the field of oncolytic virus development.
There are currently more than ten companies.
The oncolytic virus products of pharmaceutical companies have started clinical trials
.
As an important player in this field, Lepu Bio will also take a stake in Wuhan Binhui Bio to expand its deployment in the field of oncolytic viruses in addition to the CG0070 project
.
At present, the recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection of Binhui Biology has entered the phase II clinical trial phase, and the clinical trial of the combination drug with HX008 has also started
.
Reference source 1.
https:// AE-pembrolizumab-in-Non-Muscle-Invasive-Bladder-Cancer-Unresponsive-to-Bacillus-Calmette-Guerin 2.
Lepu Bio-Prospectus 3.
Happy Life Team compiled according to public information
.
The results of the test showed that among the 9 non-muscular invasive bladder cancer (NMIBC) patients who did not respond to BCG vaccine (BCG), all patients achieved complete remission (CR) at 3 months.
In addition, they reached 6 The CR rate of patients at the monthly evaluation node and the 9-month evaluation node also maintained 100%
.
NMIBC urgently needs new treatments Bladder cancer is one of the common malignant tumors of the urinary system (NMIBC accounts for 70% to 80% of bladder cancer), which has the characteristics of easy invasion, easy recurrence, easy drug resistance, and multicenter
.
In China, the incidence of bladder cancer has continued to increase year by year
.
According to Frost & Sullivan data, the number of new cases of bladder cancer in China in 2020 is 85,700, and it is expected to reach 101,100 and 117,600 in 2025 and 2030, respectively
.
The compound annual growth rate from 2020 to 2025 is 3.
4%, and the compound annual growth rate from 2025 to 2030 is 3.
1%
.
At present, the treatment methods for NMIBC are very limited.
The most commonly used treatment option is transurethral bladder tumor resection, and then according to the recurrence after surgery, intravesical perfusion treatment is adopted
.
Patients receiving this type of treatment will have up to 60% of recurrences, of which only more than 60% of patients can receive BCG (a live bacteria used to treat bladder cancer) treatment.
If BCG is ineffective/recurring, it is recommended The treatment plan is to completely remove the bladder (cystectomy), and the life after the bladder is removed is to carry a urine bag for life
.
For high-risk NMIBC patients with BCG ineffective/relapsed, new treatment options are urgently needed
.
Single-agent CR is significantly better than K drug CG0070 is an engineered adenovirus type 5 (Ad5) oncolytic virus drug developed by CG Oncology
.
Two coding genes are embedded in CG0070-tumor selective promoter E2F-1 and human granulocyte macrophage colony stimulating factor (GM-CSF) gene.
The modified Ad5 can selectively regulate defective Rb It replicates in tumor cells and finally lyses tumor cells
.
The ruptured cancer cells will further release tumor antigens and GM-CSF, stimulate the systemic anti-tumor immune response, and then reflect the dual tumor-killing effect of oncolytic viruses
.
Previously, CG Oncology has disclosed the dazzling data of the phase II clinical trial (BOND II) of a single drug of CG0070
.
The results showed that CG0070 showed a strong efficacy and good safety in highly malignant NMIBC patients who had failed BCG treatment
.
In the BOND2 trial, CG0070 achieved a significantly better CR than the K drug.
The 3-month CR rate of CG0070 was 46.
2% (40.
6% in the K drug group), and the 12-month CR rate was 29.
2% (the K drug group was 18.
7%)
.
The CR rate of combined K drugs is as high as 100%.
In addition to single drugs, CG0070 is also trying to use the combined effect of immune checkpoint inhibitors
.
Previously, CG Oncology, Merck, Roche, etc.
have reached a clinical cooperation development agreement to evaluate the potential synergistic efficacy of CG0070 and PD-1/PD-L1 inhibitors in tumors, to further improve the therapeutic effect of the drug and broaden the scope of indications
.
The clinical data of CG0070 combined with K drug released this time is also amazing
.
As of November 8, 2021, all patients who reached the 3-month assessment point (n=9) had achieved complete remission, and among the patients who reached the 6-month assessment point (n=6), all patients also maintained complete remission.
The complete remission rate of patients who reached the 9-month assessment point was still 100% (n=3)
.
CG-007 has shown extraordinary efficacy in high-risk NMIBC patients who do not respond to BCG, whether it is a single drug or a combination drug.
At present, this product has carried out a phase III clinical study for NMIBC in the United States, and it is expected to be brought to this type of patients as soon as possible.
A new and effective treatment plan
.
Domestic Lepu Biotech has the authorization for the development, manufacturing and commercialization of this product in China
.
A few days ago (November 12, 2021), Lepu Biotech has also obtained domestic clinical approval and has been approved to conduct clinical trials for non-muscle invasive bladder cancer
.
Lepu Biologics currently plans to initiate a clinical trial of CG0070 in combination with its core product HX008 for patients with advanced NMIBC.
The marketing application for new drugs for the treatment of melanoma and MSI-H/dMMR solid tumors has been accepted by the State Food and Drug Administration.
The listing application for MSI-H/dMMR solid tumors was officially included in the priority review by CDE on November 4, 2021 )
.
In addition to bladder cancer, Lepu Biotech also plans to further develop other indications such as colorectal cancer, liver cancer and breast cancer for CG0070
.
The editor concludes that as an important method in the field of tumor immunotherapy, the therapeutic potential of oncolytic virus drugs in malignant tumors and other diseases has been paid more and more attention by the scientific research community and the industry
.
According to incomplete statistics, there are about 180 oncolytic virus projects in the world.
Among them, Aglatimagene besadenovec and CG-0070 are progressing rapidly, and both are in the phase III clinical stage
.
(CG0070 is the world's first and only oncolytic virus product in the phase III clinical stage for the treatment of NMIBC).
Thanks to the advancement of genetic engineering technology, China is also increasingly active in the field of oncolytic virus development.
There are currently more than ten companies.
The oncolytic virus products of pharmaceutical companies have started clinical trials
.
As an important player in this field, Lepu Bio will also take a stake in Wuhan Binhui Bio to expand its deployment in the field of oncolytic viruses in addition to the CG0070 project
.
At present, the recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection of Binhui Biology has entered the phase II clinical trial phase, and the clinical trial of the combination drug with HX008 has also started
.
Reference source 1.
https:// AE-pembrolizumab-in-Non-Muscle-Invasive-Bladder-Cancer-Unresponsive-to-Bacillus-Calmette-Guerin 2.
Lepu Bio-Prospectus 3.
Happy Life Team compiled according to public information
