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Recently, Bristol Myers Squibb (Bristol Myers Squibb) and Bluebird Bio jointly announced that the CAR-T cell therapy Abecma jointly developed by the two parties has been approved by the U.
S.
Food and Drug Administration (FDA) for marketing.
Adult patients with relapsed/refractory multiple myeloma (r/r MM) on therapy.
This is the second CAR-T cell therapy brought by the company after BMS brought the company’s first and fourth CAR-T therapy Breyanzi last month, and the first targeted B cell maturation approved by the FDA Antigen (BCMA) CAR-T cell therapy.
So far, BMS has become the only company that has achieved the approval and listing of two CAR T cell therapies "CD19 and BCMA".
Multiple myeloma is a type of plasma cell malignant tumor.
According to statistics, as the second most common tumor in the blood system, there are approximately 160,000 new cases worldwide each year.
However, traditional treatment methods based on protease inhibitors (PI) and immunomodulators (IMID) cannot fundamentally solve the problems of high patient recurrence rate and low effective drug clearance rate, and can only prolong the patient’s 13-month period.
Survival period, so the development of new technologies is imminent.
BCMA (B cell maturation antigen) is a member of the tumor necrosis factor receptor (TNF) superfamily.
It is mainly expressed in mature B lymphocytes and plasma cells.
One of the biggest features is that it is found in all multiple myeloma (MM) cells expression.
As a candidate antigen for immunotherapy of multiple myeloma, it will activate a series of signaling pathways in cells such as p38 and EIk when combined with ligands, and plays an important role in autoimmunity and humoral immunity.
Therefore, targeted BCMA therapy has gradually entered the public's field of vision.
The therapy is mainly divided into antibody-drug conjugates (ADC), bispecific antibodies (BsAb) and chimeric antigen receptor T cell immunotherapy (CAR-T).
Among them, CAR-T cell therapy is the most popular therapy at the moment.
It is a method of modifying the T cells of patients or healthy people through genetic engineering in vitro, and then purifying and amplifying them and returning them to the patient's body to eliminate tumor cells.
A new type of immunotherapy.
The approval of Abecma is based on a phase 2 clinical trial called KarMMa.
The trial included data on 100 patients with r/r MM who had previously undergone three or more therapies.
After receiving a one-time injection of 300 to 460 x 106 CAR-positive T cells, the overall response rate (ORR) of participants was 72%, 28% of patients achieved complete remission, and approximately 65% of these patients achieved complete remission lasted for approximately 65% of remission.
For at least 12 months.
Image source: businesswire In terms of adverse reactions, Abecma mainly has two problems that lead to low levels of cytokine release syndrome (CRS) and neurotoxicity (NT).
Among them, the incidence of CRS grade 3 and above adverse reactions was 9%, and the incidence of neurotoxic grade 3 and above adverse reactions was 4%.
During the experiment, these adverse reactions could be detected and alleviated early.
At present, there are more than 60 BCMA-targeting therapies in the world that are being promoted globally.
In my country, there are more than 10 CAR-T therapies targeting BCMA that are in the clinical development stage.
They come from Legendary Biologics, Keji Biologics, Reindeer Medical/Cinda , Genxi Biological, Sibiman Biological and other companies.
End reference materials: [1] BMS official website and related media reports
S.
Food and Drug Administration (FDA) for marketing.
Adult patients with relapsed/refractory multiple myeloma (r/r MM) on therapy.
This is the second CAR-T cell therapy brought by the company after BMS brought the company’s first and fourth CAR-T therapy Breyanzi last month, and the first targeted B cell maturation approved by the FDA Antigen (BCMA) CAR-T cell therapy.
So far, BMS has become the only company that has achieved the approval and listing of two CAR T cell therapies "CD19 and BCMA".
Multiple myeloma is a type of plasma cell malignant tumor.
According to statistics, as the second most common tumor in the blood system, there are approximately 160,000 new cases worldwide each year.
However, traditional treatment methods based on protease inhibitors (PI) and immunomodulators (IMID) cannot fundamentally solve the problems of high patient recurrence rate and low effective drug clearance rate, and can only prolong the patient’s 13-month period.
Survival period, so the development of new technologies is imminent.
BCMA (B cell maturation antigen) is a member of the tumor necrosis factor receptor (TNF) superfamily.
It is mainly expressed in mature B lymphocytes and plasma cells.
One of the biggest features is that it is found in all multiple myeloma (MM) cells expression.
As a candidate antigen for immunotherapy of multiple myeloma, it will activate a series of signaling pathways in cells such as p38 and EIk when combined with ligands, and plays an important role in autoimmunity and humoral immunity.
Therefore, targeted BCMA therapy has gradually entered the public's field of vision.
The therapy is mainly divided into antibody-drug conjugates (ADC), bispecific antibodies (BsAb) and chimeric antigen receptor T cell immunotherapy (CAR-T).
Among them, CAR-T cell therapy is the most popular therapy at the moment.
It is a method of modifying the T cells of patients or healthy people through genetic engineering in vitro, and then purifying and amplifying them and returning them to the patient's body to eliminate tumor cells.
A new type of immunotherapy.
The approval of Abecma is based on a phase 2 clinical trial called KarMMa.
The trial included data on 100 patients with r/r MM who had previously undergone three or more therapies.
After receiving a one-time injection of 300 to 460 x 106 CAR-positive T cells, the overall response rate (ORR) of participants was 72%, 28% of patients achieved complete remission, and approximately 65% of these patients achieved complete remission lasted for approximately 65% of remission.
For at least 12 months.
Image source: businesswire In terms of adverse reactions, Abecma mainly has two problems that lead to low levels of cytokine release syndrome (CRS) and neurotoxicity (NT).
Among them, the incidence of CRS grade 3 and above adverse reactions was 9%, and the incidence of neurotoxic grade 3 and above adverse reactions was 4%.
During the experiment, these adverse reactions could be detected and alleviated early.
At present, there are more than 60 BCMA-targeting therapies in the world that are being promoted globally.
In my country, there are more than 10 CAR-T therapies targeting BCMA that are in the clinical development stage.
They come from Legendary Biologics, Keji Biologics, Reindeer Medical/Cinda , Genxi Biological, Sibiman Biological and other companies.
End reference materials: [1] BMS official website and related media reports
