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Recent popular reports from Yimaike★ Hot nucleic acid drugs! Come and see what types of nucleic acid drugs are availableYimai Meng broke the news May Nanjing2021 nucleic acid drug development forum is about to open May 5, 2021 / Yimaike News eMedClub News/--Gliomas are among all current tumors One of the most difficult malignant tumors to conquer, the prognosis is extremely poor, seriously endangering life and health.
Recently, it was learned from Professor Huang Yulun, the chief physician of neurosurgery of the First Affiliated Hospital of Soochow University and the director of neurosurgery of Soochow University Medical Center (Suzhou University Dushu Lake Hospital): With the joint efforts and cooperation of Huang Yulun’s team and cooperating units, after more than two years The investigators initiated a clinical trial.
Recently, three patients with relapsed advanced glioblastoma showed a 100% objective response rate.
Through 2-6 courses of new CAR-T cell therapy, MRI showed that: 1 patient showed complete response (CR), that is, the tumor disappeared completely.
As of the date of publication, CR has lasted for 5 and a half months.
Two patients showed partial response (PR), with tumor shrinkage between 40% and 80%.
The longest enrolled patient has survived more than 22 months after recurrence (the average survival time of patients with recurrent glioma is about 6 months), and is currently in good condition.
These research results have brought dawn to patients with advanced recurrent glioma, and also represent an important milestone.
After receiving the new CAR-T cell treatment of Suzhou Maoxing Biotechnology, three patients only developed symptoms such as fever and vomiting that lasted for 3-6 days, and no side effects of grade 3 or above were seen.
They obtained excellent curative effects and demonstrated good safety.
.
It is understood that the earliest and most clinical research institution using CAR-T cells for glioma is City of Hope Hospital in the United States.
IL13Rα2 targeting CAR-T cells is the first clinical trial of City of Hope for the treatment of malignant glioma.
The first-generation IL13-zetakine CD8 T cell clone used autologous (NCT00730613, 3 cases) and allogeneic (NCT 01082926, 6 cases) engineered T cells in two clinical trials authorized by the FDA for resectable and unresectable T cells.
Recurrent GBM.
In 2015, City of Hope initiated another phase of clinical trial to evaluate second-generation IL13Rα2-targeted, 4-1BB co-stimulated CAR-T cells (NCT02208362) for patients with relapsed/refractory IL13Rα2+ malignant glioma.
The third clinical study reported a successful case of multiple infusions of CAR-T cells through two intracranial delivery routes in more than 220 days-infusion into the tumor cavity and into the ventricular system.
Intracranial perfusion of IL13Rα2 targeting CAR-T cells has nothing to do with any grade 3 or above toxic effects.
After CAR-T treatment, it was observed that all intracranial and spinal cord tumors subsided, accompanied by a corresponding increase in the levels of cytokines and immune cells in the cerebrospinal fluid.
This clinical response lasted for 7.
5 months after the start of CAR-T treatment.
Compared with the CAR-T cells used in the Glioma Clinical Research Institute of City of Hope Hospital in the United States, the new CAR-T cells of Huang Yulun's expert team for glioma have the following three notable features: 1) Shorter onset time, CR or PR occurred in only two treatment cycles, while CR patients in the City of Hope Hospital clinical study did not begin to show tumor regression after at least 10 treatment cycles; 2) The dose is smaller, and the clinical study of the City of Hope Hospital is in clinical research.
The maximum dosage of cells is 1x108 cells/patient, and there is one treatment cycle per week, while Yulun Huang’s expert team only uses 2-3x107 cells/patient, and the treatment cycle is one month; 3) Higher efficiency, NCT 02208362, City of Hope Hospital, USA Since the start of the clinical study, more than ten patients have been enrolled, with only 1 CR and 2 PR results.
Since the start of the new CAR-T cell therapy by Huang Yulun in 2020, only 3 patients have been enrolled.
, But achieved 1 case of CR and 2 cases of PR, 100% effective and gratifying results, and the curative effect is significantly better than the clinical research of the City of Hope Hospital in the United States. It is reported that the clinical research was conducted by Huang Yulun's expert team in cooperation with Suzhou Maoxing Biotechnology, located in the Suzhou Industrial Park.
Based on the platform of general-purpose T cells, Maoxing Biotech is committed to solving unmet clinical needs in tumors, autoimmune diseases, neurodegenerative diseases and other fields.
According to Dr.
Shang Xiaoyun, founder and CEO of Maoxing Biotechnology, the company's new CAR-T cells have achieved such breakthrough results in solid tumors, mainly due to the following three points: (1) Allogeneic universal CAR-T technology: this The core raw material of the product-T cells are collected from healthy volunteers.
Compared with T cells from tumor patients, the activity of T cells from healthy donors is thousands of times; at the same time, the company's new generation of technical solutions better solves the rejection.
Question, we have obtained excellent data on the survival of allogeneic CAR-T cells in humanized immune system mice for nearly three months; (2) Optimized T cell culture process: The optimized process can obtain more memory T cells, The early differentiation state of T cells can be maintained during the in vitro preparation process, so that the company's new CAR-T cells can obtain an ideal half-life time after entering the body; (3) Deep understanding of the indications and continuous exploration of appropriate clinical programs and administration way.
At present, the exploration of indications for solid tumors other than glioma is ongoing.
Based on the above three points, Maoxing Biotech CEO Dr.
Shang Xiaoyun believes that the company's new universal CAR-T therapy will make further breakthroughs in more solid tumor indications.
Maoxing Biotech pays special attention to original research, adhering to the concept of "in China, for Global", and insisting on developing innovative products with global strategies.
As Dr.
Shang Xiaoyun said: "Under the background of centralized national procurement, early start-up companies such as Maoxing Biotechnology will have no way to survive without global innovation.
" The company is preparing the first and second product pipelines in the US The two places apply for clinical registration, and it is expected that a global multi-center clinical study will be launched at the end of 2022.
It is expected that glioma-related pipeline products will be quickly introduced to the market, and the products will be launched in the next 4-5 years, so that patients with glioma will benefit as soon as possible.
In addition to the planning and layout of product pipelines, in terms of business, since the new universal T cell mastered by Maoxing is a platform technology, Maoxing Bioplans to establish cooperation with internationally renowned large pharmaceutical companies in the next few years to expand more pipelines and joint ventures.
Develop the global market.
Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, of which industrial users accounted for more than 50%, and scientific research and clinical users accounted for about 30%.
More than 5% of users of investment institutions.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
Recently, it was learned from Professor Huang Yulun, the chief physician of neurosurgery of the First Affiliated Hospital of Soochow University and the director of neurosurgery of Soochow University Medical Center (Suzhou University Dushu Lake Hospital): With the joint efforts and cooperation of Huang Yulun’s team and cooperating units, after more than two years The investigators initiated a clinical trial.
Recently, three patients with relapsed advanced glioblastoma showed a 100% objective response rate.
Through 2-6 courses of new CAR-T cell therapy, MRI showed that: 1 patient showed complete response (CR), that is, the tumor disappeared completely.
As of the date of publication, CR has lasted for 5 and a half months.
Two patients showed partial response (PR), with tumor shrinkage between 40% and 80%.
The longest enrolled patient has survived more than 22 months after recurrence (the average survival time of patients with recurrent glioma is about 6 months), and is currently in good condition.
These research results have brought dawn to patients with advanced recurrent glioma, and also represent an important milestone.
After receiving the new CAR-T cell treatment of Suzhou Maoxing Biotechnology, three patients only developed symptoms such as fever and vomiting that lasted for 3-6 days, and no side effects of grade 3 or above were seen.
They obtained excellent curative effects and demonstrated good safety.
.
It is understood that the earliest and most clinical research institution using CAR-T cells for glioma is City of Hope Hospital in the United States.
IL13Rα2 targeting CAR-T cells is the first clinical trial of City of Hope for the treatment of malignant glioma.
The first-generation IL13-zetakine CD8 T cell clone used autologous (NCT00730613, 3 cases) and allogeneic (NCT 01082926, 6 cases) engineered T cells in two clinical trials authorized by the FDA for resectable and unresectable T cells.
Recurrent GBM.
In 2015, City of Hope initiated another phase of clinical trial to evaluate second-generation IL13Rα2-targeted, 4-1BB co-stimulated CAR-T cells (NCT02208362) for patients with relapsed/refractory IL13Rα2+ malignant glioma.
The third clinical study reported a successful case of multiple infusions of CAR-T cells through two intracranial delivery routes in more than 220 days-infusion into the tumor cavity and into the ventricular system.
Intracranial perfusion of IL13Rα2 targeting CAR-T cells has nothing to do with any grade 3 or above toxic effects.
After CAR-T treatment, it was observed that all intracranial and spinal cord tumors subsided, accompanied by a corresponding increase in the levels of cytokines and immune cells in the cerebrospinal fluid.
This clinical response lasted for 7.
5 months after the start of CAR-T treatment.
Compared with the CAR-T cells used in the Glioma Clinical Research Institute of City of Hope Hospital in the United States, the new CAR-T cells of Huang Yulun's expert team for glioma have the following three notable features: 1) Shorter onset time, CR or PR occurred in only two treatment cycles, while CR patients in the City of Hope Hospital clinical study did not begin to show tumor regression after at least 10 treatment cycles; 2) The dose is smaller, and the clinical study of the City of Hope Hospital is in clinical research.
The maximum dosage of cells is 1x108 cells/patient, and there is one treatment cycle per week, while Yulun Huang’s expert team only uses 2-3x107 cells/patient, and the treatment cycle is one month; 3) Higher efficiency, NCT 02208362, City of Hope Hospital, USA Since the start of the clinical study, more than ten patients have been enrolled, with only 1 CR and 2 PR results.
Since the start of the new CAR-T cell therapy by Huang Yulun in 2020, only 3 patients have been enrolled.
, But achieved 1 case of CR and 2 cases of PR, 100% effective and gratifying results, and the curative effect is significantly better than the clinical research of the City of Hope Hospital in the United States. It is reported that the clinical research was conducted by Huang Yulun's expert team in cooperation with Suzhou Maoxing Biotechnology, located in the Suzhou Industrial Park.
Based on the platform of general-purpose T cells, Maoxing Biotech is committed to solving unmet clinical needs in tumors, autoimmune diseases, neurodegenerative diseases and other fields.
According to Dr.
Shang Xiaoyun, founder and CEO of Maoxing Biotechnology, the company's new CAR-T cells have achieved such breakthrough results in solid tumors, mainly due to the following three points: (1) Allogeneic universal CAR-T technology: this The core raw material of the product-T cells are collected from healthy volunteers.
Compared with T cells from tumor patients, the activity of T cells from healthy donors is thousands of times; at the same time, the company's new generation of technical solutions better solves the rejection.
Question, we have obtained excellent data on the survival of allogeneic CAR-T cells in humanized immune system mice for nearly three months; (2) Optimized T cell culture process: The optimized process can obtain more memory T cells, The early differentiation state of T cells can be maintained during the in vitro preparation process, so that the company's new CAR-T cells can obtain an ideal half-life time after entering the body; (3) Deep understanding of the indications and continuous exploration of appropriate clinical programs and administration way.
At present, the exploration of indications for solid tumors other than glioma is ongoing.
Based on the above three points, Maoxing Biotech CEO Dr.
Shang Xiaoyun believes that the company's new universal CAR-T therapy will make further breakthroughs in more solid tumor indications.
Maoxing Biotech pays special attention to original research, adhering to the concept of "in China, for Global", and insisting on developing innovative products with global strategies.
As Dr.
Shang Xiaoyun said: "Under the background of centralized national procurement, early start-up companies such as Maoxing Biotechnology will have no way to survive without global innovation.
" The company is preparing the first and second product pipelines in the US The two places apply for clinical registration, and it is expected that a global multi-center clinical study will be launched at the end of 2022.
It is expected that glioma-related pipeline products will be quickly introduced to the market, and the products will be launched in the next 4-5 years, so that patients with glioma will benefit as soon as possible.
In addition to the planning and layout of product pipelines, in terms of business, since the new universal T cell mastered by Maoxing is a platform technology, Maoxing Bioplans to establish cooperation with internationally renowned large pharmaceutical companies in the next few years to expand more pipelines and joint ventures.
Develop the global market.
Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reached 160,000+, of which industrial users accounted for more than 50%, and scientific research and clinical users accounted for about 30%.
More than 5% of users of investment institutions.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
