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Recent popular reports from Yimaike ★ Milestone cooperation in gene therapy in China, viral vector CDMO Paizhen Biotechnology cooperates with Pall to develop gene therapy production technologyYimai Meng broke the news ★ It will be launched in March, the first BCMA CAR-T therapy submitted for marketing is released.
Phase II research dataMedClub New Observation February 28, 2021/MedClub News/--Nanjing Beiheng Biotechnology Co.
, Ltd.
and the First Affiliated Hospital of Zhejiang University School of Medicine jointly published the first article based on CRISPR/Cas9 gene The edited CD19/CD22 dual target universal CAR-T cell product CTA101 for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) clinical research paper.
The research results were published online in the medical journal Clinical Cancer Research on February 24, 2021.
Professor Huang He and Dr.
Jiangtao Ren are the co-corresponding authors of the paper.
The research is a clinical research (IIT) initiated by the researcher.
The main researcher is Professor Huang He from the First Affiliated Hospital of Zhejiang University School of Medicine.
The study released the treatment of 6 patients with r/r B-ALL.
The 6 patients had received severe treatment in the past, of which 3 had hyperleukocytic leukemia before enrollment, 1 had severe lymphocyte deficiency, and 1 had recurrence within 3 months after autologous CD22 CAR-T treatment.
All enrolled patients successfully received the infusion, and the interval from enrollment to infusion was no more than 8 days.
Image source: Clinical Cancer Research results show that no dose-limiting toxicity (DLTs), graft-versus-host disease (GvHD) or neurotoxicity events have occurred, and no replication-competent lentivirus and CRISPR/Cas9 genome editing-related adverse events have been detected (AEs).
CRS is mainly mild to moderate.
Only one of the 6 patients with CRS experienced CRS above grade 3 (grade 3).
This patient was relieved after tocilizumab and glucocorticoid treatment.
During the study, no AEs related to CTA101 treatment leading to early withdrawal or death occurred.
Shows that CTA101 has better safety characteristics.
Preliminary verification of CTA101's powerful anti-tumor efficacy and its ability to expand in vivo.
Five patients (83%) got CR/CRi, and all got MRD-.
To the median follow-up time of 4.
3 months, 3 of the 5 patients with CR/CRi still maintained MRD-.
The peripheral blood qPCR and flow cytometry of 5 responding patients all detected significant amplification of CTA101.
The results of this study show that CTA101 has controllable safety and significant anti-leukemia activity in the treatment of relapsed/refractory B-ALL, which preliminarily proves the safety and feasibility of CRISPR/Cas9 gene-edited universal CAR-T cell products.
The "off-the-shelf" universal CAR-T cell products have a low shedding rate before infusion, a short waiting time for infusion, and a wide range of applications, which provide more choices for patients with relapsed/refractory B-ALL.
About CTA101 CTA101 is a standardized and mass-produced CD19/CD22 dual-target universal CAR-T cell injection developed by Nanjing Beiheng Biotechnology based on the company's first-generation universal technology platform, which has realized "off-the-shelf supply" and does not require HLA matching.
The T cells needed for preparation are from healthy donors, and a single batch of production can meet the needs of one hundred people.
The use of CRISPR/Cas9 high-efficiency gene editing technology can effectively avoid GvHD and the patient's immune rejection of the infused CAR-T cells.
About Beiheng BioNanjing Beiheng Biotechnology Co.
, Ltd.
was established in 2017.
It is an innovative biomedical company focusing on the development and commercialization of disease treatment products.
It was co-founded by doctors from top universities at home and abroad and an experienced operating team.
The business covers areas such as immunotherapy and gene therapy. Beiheng Biotechnology now has a high-standard clinical transformation center and GMP production workshop of 7,500 square meters, covering plasmid virus production, cell amplification and quality control, etc.
, in line with the strict standards of FDA and NMPA for cell therapy products supervision.
Nanjing Beiheng Biotechnology has successively received more than 100 million investments from Simcere Pharmaceutical, Decheng Capital and Peking University Medical.
As of the end of 2020, the company has applied for 34 core patents, and has been selected into the Jiangsu "Double Innovation Talent" Program, Nanjing High-level Entrepreneur Talent Introduction Program, Nanjing Expert Studio, etc.
; it has obtained the national technology-based small and medium-sized enterprises, intellectual property management system Certification enterprise, Nanjing municipal engineering research and development center and other honors.
The fifth-generation "off-the-shelf" universal CAR-T cell therapy product developed by Beiheng Biological has the international leading level of research and development, and is expected to fundamentally solve the current CAR-T therapy "high cost, long time, difficult production, and individualization" The dilemma of realizing the affordability and accessibility of immune cell therapy.
Build a bridge between life and health, and let every patient get a chance to heal.
Data source: https://clincancerres.
aacrjournals.
org/content/early/2021/02/23/1078-0432.
CCR-20-3863.
Clincancerres has always been committed to cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs According to original news reports, all-media high-end matrix users reached 160,000+, among which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
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.
Phase II research dataMedClub New Observation February 28, 2021/MedClub News/--Nanjing Beiheng Biotechnology Co.
, Ltd.
and the First Affiliated Hospital of Zhejiang University School of Medicine jointly published the first article based on CRISPR/Cas9 gene The edited CD19/CD22 dual target universal CAR-T cell product CTA101 for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) clinical research paper.
The research results were published online in the medical journal Clinical Cancer Research on February 24, 2021.
Professor Huang He and Dr.
Jiangtao Ren are the co-corresponding authors of the paper.
The research is a clinical research (IIT) initiated by the researcher.
The main researcher is Professor Huang He from the First Affiliated Hospital of Zhejiang University School of Medicine.
The study released the treatment of 6 patients with r/r B-ALL.
The 6 patients had received severe treatment in the past, of which 3 had hyperleukocytic leukemia before enrollment, 1 had severe lymphocyte deficiency, and 1 had recurrence within 3 months after autologous CD22 CAR-T treatment.
All enrolled patients successfully received the infusion, and the interval from enrollment to infusion was no more than 8 days.
Image source: Clinical Cancer Research results show that no dose-limiting toxicity (DLTs), graft-versus-host disease (GvHD) or neurotoxicity events have occurred, and no replication-competent lentivirus and CRISPR/Cas9 genome editing-related adverse events have been detected (AEs).
CRS is mainly mild to moderate.
Only one of the 6 patients with CRS experienced CRS above grade 3 (grade 3).
This patient was relieved after tocilizumab and glucocorticoid treatment.
During the study, no AEs related to CTA101 treatment leading to early withdrawal or death occurred.
Shows that CTA101 has better safety characteristics.
Preliminary verification of CTA101's powerful anti-tumor efficacy and its ability to expand in vivo.
Five patients (83%) got CR/CRi, and all got MRD-.
To the median follow-up time of 4.
3 months, 3 of the 5 patients with CR/CRi still maintained MRD-.
The peripheral blood qPCR and flow cytometry of 5 responding patients all detected significant amplification of CTA101.
The results of this study show that CTA101 has controllable safety and significant anti-leukemia activity in the treatment of relapsed/refractory B-ALL, which preliminarily proves the safety and feasibility of CRISPR/Cas9 gene-edited universal CAR-T cell products.
The "off-the-shelf" universal CAR-T cell products have a low shedding rate before infusion, a short waiting time for infusion, and a wide range of applications, which provide more choices for patients with relapsed/refractory B-ALL.
About CTA101 CTA101 is a standardized and mass-produced CD19/CD22 dual-target universal CAR-T cell injection developed by Nanjing Beiheng Biotechnology based on the company's first-generation universal technology platform, which has realized "off-the-shelf supply" and does not require HLA matching.
The T cells needed for preparation are from healthy donors, and a single batch of production can meet the needs of one hundred people.
The use of CRISPR/Cas9 high-efficiency gene editing technology can effectively avoid GvHD and the patient's immune rejection of the infused CAR-T cells.
About Beiheng BioNanjing Beiheng Biotechnology Co.
, Ltd.
was established in 2017.
It is an innovative biomedical company focusing on the development and commercialization of disease treatment products.
It was co-founded by doctors from top universities at home and abroad and an experienced operating team.
The business covers areas such as immunotherapy and gene therapy. Beiheng Biotechnology now has a high-standard clinical transformation center and GMP production workshop of 7,500 square meters, covering plasmid virus production, cell amplification and quality control, etc.
, in line with the strict standards of FDA and NMPA for cell therapy products supervision.
Nanjing Beiheng Biotechnology has successively received more than 100 million investments from Simcere Pharmaceutical, Decheng Capital and Peking University Medical.
As of the end of 2020, the company has applied for 34 core patents, and has been selected into the Jiangsu "Double Innovation Talent" Program, Nanjing High-level Entrepreneur Talent Introduction Program, Nanjing Expert Studio, etc.
; it has obtained the national technology-based small and medium-sized enterprises, intellectual property management system Certification enterprise, Nanjing municipal engineering research and development center and other honors.
The fifth-generation "off-the-shelf" universal CAR-T cell therapy product developed by Beiheng Biological has the international leading level of research and development, and is expected to fundamentally solve the current CAR-T therapy "high cost, long time, difficult production, and individualization" The dilemma of realizing the affordability and accessibility of immune cell therapy.
Build a bridge between life and health, and let every patient get a chance to heal.
Data source: https://clincancerres.
aacrjournals.
org/content/early/2021/02/23/1078-0432.
CCR-20-3863.
Clincancerres has always been committed to cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs According to original news reports, all-media high-end matrix users reached 160,000+, among which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.
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.
