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Recent popular reports from Yimicike ★ Dialogue with Sartorius Wang Xuyu | Behind the new application service center, Sartorius’s innovation philosophy ★ Teflon Medical Equipment meets you at the 2021 Shanghai (Minhang) Biomedical Industry Innovation Summit October 12, 2021/ EMedClub News/--In recent years, CAR-T cell therapy has become more and more known to the public, and a large number of biopharmaceutical companies have joined the team of CAR-T cell immunotherapy
.
Recently, another indication for Gilead's cancer cell therapy Tecartus has been approved by the US FDA for the treatment of adult elderly acute lymphoblastic leukemia
.
The CAR-T drug Kymriah approved by Novartis in 2017 mainly treats children and young patients under 25 years of age with acute lymphoblastic leukemia (ALL)
.
In 2017, the FDA awarded Tecartus the title of breakthrough therapy for the treatment of relapsed or refractory adult precursor B-cell ALL
.
On July 27, 2020, it was approved by the FDA for marketing in the United States, becoming the world's first and only CAR-T cell therapy product approved for the treatment of MCL
.
In October 2020, Tecartus was approved for EU CHMP support
.
In addition, Gilead’s other CAR-T cell therapy, Yescarta, was approved by the FDA in the fall of 2017.
It is the world’s second CAR-T product approved for marketing after Novartis’ KYMRIAH® (tisagenlecleucel), and it is also the world’s first.
Approved for CAR-T products for non-Hodgkin's lymphoma
.
In February 2019, Health Canada approved Yescarta's listing in Canada
.
In December 2020, the Canadian province of Ontario has included the CAR-T product Yescarta of Gilead Sciences’ company Kite Pharma in its medical insurance for relapsed or refractory large B-cell lymphomas after second-line or above systemic treatment, including diffuse large B Cell lymphoma (DLBCL) non-specific, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL
.
In March 2021, the US FDA approved Yescarta's second indication, which is mainly used for second-line or above treatment of adult patients with relapsed/refractory follicular lymphoma (FL)
.
Various signs indicate that Gilead’s Kite company is expanding in an orderly manner in CAR-T therapy
.
CAR-T therapy with the same target CD19 has always been the hotter target of CD19.
CAR-T cells targeting CD19 have impressive anti-tumor effects, which also promotes CAR-T in tumor treatment.
The speed of research and development
.
In August 2017, Novartis’ first CAR-T drug Kymriah was approved by the U.
S.
FDA and became the world’s first CAR-T therapy for the treatment of children and young patients under 25 years of age with acute lymphoblastic leukemia (ALL).
The first indication of the drug
.
On October 30, 2019, the CDE official website announced that Novartis Biomedical Research Co.
, Ltd.
submitted a CTL019 drug Kymriah for CAR-T therapy in China in August and obtained implied approval in a clinical trial application.
The indication is recurrent.
Or refractory aggressive B-cell non-Hodgkin lymphoma
.
On March 9, 2021, Novartis announced that under the new cell, tissue, and gene therapy product (CTGTP) regulatory framework, the Singapore Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) for the treatment of the drug.
The two approved indications are ALL and DLBCL
.
Recommended reading: Following Japan, Novartis CAR-T cells are approved for listing in Singapore! CAR-T cell therapy boom is about to sweep AsiaYimai Meng broke the news.
In September 2021, Autolus Therapeutics, a clinical-stage biopharmaceutical company, announced that it will publish Obe-cel (AUTO1) Phase 1 ALLCAR19 adult relapse/difficulty in the Journal of Clinical Oncology Therapeutic B-ALL data
.
Obe-cel is a CAR-T therapy that targets CD19 with a fast target binding and dissociation rate, which aims to reduce toxicity and improve implantation
.
Recommended reading: Phase 1 clinical data is encouraging! "Serial killer" CD19 CAR-T reappearsYimai Meng broke the news.
In April 2021, Ziopharm Oncology announced that its TriArm Therapeutics (hereinafter referred to as TriArm) joint venture company Eden BioCell Limited carried out "RPM anti-CD19 autologous CAR-T cell infusion".
In the phase 1 clinical study of "Injection", the first patient was successfully administered, mainly for patients with CD19+ leukemia and lymphoma recurrence Dosing in TaiwanMedical Meng broke the news.
In January 2021, Precision BioSciences, headquartered in North Carolina, USA, announced that the US FDA has accepted the IND application for PBCAR19B
.
PBCAR19B is an allogeneic CD19 CAR-T cell product candidate for the treatment of relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL)
.
In order to improve the persistence of allogeneic CAR-T cells after infusion, PBCAR19B is designed to prevent rejection of T cells and NK cells
.
Recommended reading: Allogeneic "invisible" CD19 CAR-T cells that will not be detected by T cells and NK cellsYiMike broke the news.
This issue of YiMike will join hands with ProteinSimple to launch a live event on October 13th with the theme "iCE3" & Maurice Global Multi-center Comparative Research" live online course, invited ProteinSimple Marketing Manager Hao Dianming; Shanghai Fuhong Henlius Bioanalysis and Development Department Senior Director of Physical and Chemical Analysis Jing Ye; ProteinSimple Technical Support Manager Dr.
Du Yingying, to bring the audience ProteinSimple full column imaging capillary technology research data, and capillary electrophoresis technology to simplify the drug development process experience sharing
.
Help scientists in the fields of biopharmaceuticals, cell therapy, biomedicine, and life sciences solve protein analysis problems, and deeply analyze the relationship between protein and disease
.
Scan the QR code to register now, and watch the live medical course for free.
Topic: iCE3 & Maurice Global Multi-center Comparative Research Live Time: October 13, 2021 15:00-16:20 Course topic: ProteinSimple full-column imaging capillary technology Past, present and future course summary ➤ The history of the development of a new generation of full-column imaging capillary electrophoresis technology ➤ The evolutionary history of products based on the full-column imaging capillary technology: Maurice VS ICE3 ➤ The development direction of the future full-column imaging capillary technology ➤ The CE-SDS analysis mode of Maurice antibody drugs Course topic: Summary of a global multi-center collaborative research course on the comparability of iCE3 and Maurice charge heterogeneity analysis data ➤ The precision and robustness of the isoelectric focusing electrophoresis method for a NIST monoclonal antibody and a fusion protein ➤ iCE and Maurice two instruments ➤ Participants will learn about the precision and robustness results of iCE3 and Maurice for monoclonal antibodies and fusion proteins
.
Course topic: Capillary electrophoresis technology simplifies your drug development process Course summary ➤ The development of protein drugs and gene therapy products requires reliable analysis tools to be able to quickly and comprehensively characterize these complex molecules ➤ The development of protein drugs and gene therapy products requires Reliable analysis tools that can quickly and comprehensively characterize these complex molecules ➤ Participants will learn how Maurice's charge and molecular weight analysis supports the development and characterization of protein drugs and gene therapy products
.
The content is exciting, so please sign up! Reference materials: 1.
https://
.
Recently, another indication for Gilead's cancer cell therapy Tecartus has been approved by the US FDA for the treatment of adult elderly acute lymphoblastic leukemia
.
The CAR-T drug Kymriah approved by Novartis in 2017 mainly treats children and young patients under 25 years of age with acute lymphoblastic leukemia (ALL)
.
In 2017, the FDA awarded Tecartus the title of breakthrough therapy for the treatment of relapsed or refractory adult precursor B-cell ALL
.
On July 27, 2020, it was approved by the FDA for marketing in the United States, becoming the world's first and only CAR-T cell therapy product approved for the treatment of MCL
.
In October 2020, Tecartus was approved for EU CHMP support
.
In addition, Gilead’s other CAR-T cell therapy, Yescarta, was approved by the FDA in the fall of 2017.
It is the world’s second CAR-T product approved for marketing after Novartis’ KYMRIAH® (tisagenlecleucel), and it is also the world’s first.
Approved for CAR-T products for non-Hodgkin's lymphoma
.
In February 2019, Health Canada approved Yescarta's listing in Canada
.
In December 2020, the Canadian province of Ontario has included the CAR-T product Yescarta of Gilead Sciences’ company Kite Pharma in its medical insurance for relapsed or refractory large B-cell lymphomas after second-line or above systemic treatment, including diffuse large B Cell lymphoma (DLBCL) non-specific, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and follicular lymphoma transformed DLBCL
.
In March 2021, the US FDA approved Yescarta's second indication, which is mainly used for second-line or above treatment of adult patients with relapsed/refractory follicular lymphoma (FL)
.
Various signs indicate that Gilead’s Kite company is expanding in an orderly manner in CAR-T therapy
.
CAR-T therapy with the same target CD19 has always been the hotter target of CD19.
CAR-T cells targeting CD19 have impressive anti-tumor effects, which also promotes CAR-T in tumor treatment.
The speed of research and development
.
In August 2017, Novartis’ first CAR-T drug Kymriah was approved by the U.
S.
FDA and became the world’s first CAR-T therapy for the treatment of children and young patients under 25 years of age with acute lymphoblastic leukemia (ALL).
The first indication of the drug
.
On October 30, 2019, the CDE official website announced that Novartis Biomedical Research Co.
, Ltd.
submitted a CTL019 drug Kymriah for CAR-T therapy in China in August and obtained implied approval in a clinical trial application.
The indication is recurrent.
Or refractory aggressive B-cell non-Hodgkin lymphoma
.
On March 9, 2021, Novartis announced that under the new cell, tissue, and gene therapy product (CTGTP) regulatory framework, the Singapore Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) for the treatment of the drug.
The two approved indications are ALL and DLBCL
.
Recommended reading: Following Japan, Novartis CAR-T cells are approved for listing in Singapore! CAR-T cell therapy boom is about to sweep AsiaYimai Meng broke the news.
In September 2021, Autolus Therapeutics, a clinical-stage biopharmaceutical company, announced that it will publish Obe-cel (AUTO1) Phase 1 ALLCAR19 adult relapse/difficulty in the Journal of Clinical Oncology Therapeutic B-ALL data
.
Obe-cel is a CAR-T therapy that targets CD19 with a fast target binding and dissociation rate, which aims to reduce toxicity and improve implantation
.
Recommended reading: Phase 1 clinical data is encouraging! "Serial killer" CD19 CAR-T reappearsYimai Meng broke the news.
In April 2021, Ziopharm Oncology announced that its TriArm Therapeutics (hereinafter referred to as TriArm) joint venture company Eden BioCell Limited carried out "RPM anti-CD19 autologous CAR-T cell infusion".
In the phase 1 clinical study of "Injection", the first patient was successfully administered, mainly for patients with CD19+ leukemia and lymphoma recurrence Dosing in TaiwanMedical Meng broke the news.
In January 2021, Precision BioSciences, headquartered in North Carolina, USA, announced that the US FDA has accepted the IND application for PBCAR19B
.
PBCAR19B is an allogeneic CD19 CAR-T cell product candidate for the treatment of relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL)
.
In order to improve the persistence of allogeneic CAR-T cells after infusion, PBCAR19B is designed to prevent rejection of T cells and NK cells
.
Recommended reading: Allogeneic "invisible" CD19 CAR-T cells that will not be detected by T cells and NK cellsYiMike broke the news.
This issue of YiMike will join hands with ProteinSimple to launch a live event on October 13th with the theme "iCE3" & Maurice Global Multi-center Comparative Research" live online course, invited ProteinSimple Marketing Manager Hao Dianming; Shanghai Fuhong Henlius Bioanalysis and Development Department Senior Director of Physical and Chemical Analysis Jing Ye; ProteinSimple Technical Support Manager Dr.
Du Yingying, to bring the audience ProteinSimple full column imaging capillary technology research data, and capillary electrophoresis technology to simplify the drug development process experience sharing
.
Help scientists in the fields of biopharmaceuticals, cell therapy, biomedicine, and life sciences solve protein analysis problems, and deeply analyze the relationship between protein and disease
.
Scan the QR code to register now, and watch the live medical course for free.
Topic: iCE3 & Maurice Global Multi-center Comparative Research Live Time: October 13, 2021 15:00-16:20 Course topic: ProteinSimple full-column imaging capillary technology Past, present and future course summary ➤ The history of the development of a new generation of full-column imaging capillary electrophoresis technology ➤ The evolutionary history of products based on the full-column imaging capillary technology: Maurice VS ICE3 ➤ The development direction of the future full-column imaging capillary technology ➤ The CE-SDS analysis mode of Maurice antibody drugs Course topic: Summary of a global multi-center collaborative research course on the comparability of iCE3 and Maurice charge heterogeneity analysis data ➤ The precision and robustness of the isoelectric focusing electrophoresis method for a NIST monoclonal antibody and a fusion protein ➤ iCE and Maurice two instruments ➤ Participants will learn about the precision and robustness results of iCE3 and Maurice for monoclonal antibodies and fusion proteins
.
Course topic: Capillary electrophoresis technology simplifies your drug development process Course summary ➤ The development of protein drugs and gene therapy products requires reliable analysis tools to be able to quickly and comprehensively characterize these complex molecules ➤ The development of protein drugs and gene therapy products requires Reliable analysis tools that can quickly and comprehensively characterize these complex molecules ➤ Participants will learn how Maurice's charge and molecular weight analysis supports the development and characterization of protein drugs and gene therapy products
.
The content is exciting, so please sign up! Reference materials: 1.
https://
