-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
December 31, 2021/eMedClub News/--Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson Group, submitted to the U.
S.
Food and Drug Administration (FDA) its biologics license for subcutaneous injection of bi-antibody therapy teclistamab Application (BLA)
.
The drug targets B cell maturation antigen (BCMA) and CD3, and is being developed for the treatment of relapsed or refractory (r/r) multiple myeloma
.
Multiple myeloma (MM) is the second most common hematological malignancy after non-Hodgkin's lymphoma and cannot be cured
.
In this disease, clonal plasma cells in the bone marrow deteriorate and abnormally proliferate.
Malignant plasma cells can replace normal blood cells in the body, leading to anemia and uncontrollable bleeding
.
It can also cause bone density and strength problems, and increase the risk of infection by reducing the body's immune response
.
In recent years, despite great progress in chemotherapy, proteasome inhibitors, and immunomodulator thalidomide derivatives, almost all patients will eventually relapse
.
Therefore, there is an urgent need for new treatment options
.
With the in-depth research on the disease biology and therapeutic targets of MM, some targeted therapies have shown good therapeutic effects
.
BCMA (B cell maturation antigen) is one of the important markers on the surface of mature B cells.
It is highly expressed on all MM cells and is not expressed in other normal tissues (except plasma cells).
Therefore, it has become a new treatment strategy for MM patients.
A very hot target in the middle
.
Teclistamab is a bispecific antibody developed using Genmab DuoBody® technology that can simultaneously target T cell CD3 and multiple myeloma (MM) cell BCMA
.
The role of Teclistamab is to make T cells with tumor-killing effect gather around MM cells expressing BCMA, so that T cells can be activated and redirected to kill BCMA-positive cancer cells
.
▲The mechanism of action of teclistamab (picture source: Janssen official website) BCMxCD3 double antibody has excellent overall remission rate To evaluate the safety and effectiveness of drugs in multiple myeloma
.
The latest clinical results published by ASH showed that among severely pretreated patients who received subcutaneous injection of teclistamab, the overall response rate (ORR) reached 62% (n=93/150), and the patients who achieved partial response (PR) were 58%, strictly speaking, 21% of patients achieved complete remission (CR)
.
At a median follow-up time of 9 months, 59% of patients had no disease progression after remission, and the cellular response deepened over time
.
“The deep expertise, creativity and perseverance of the entire Janssen R&D organization enable teclistamab to rapidly advance the treatment of multiple myeloma,” said Dr.
Mathai Mammen, global head of Janssen R&D at Johnson & Johnson.
“Today’s submission is our commitment to patients.
Another important step to bring truly transformative drugs, these drugs will have a profound impact on their health
.
"The double antibodies against BCMA cannot be ignored in the strategy of treating MM against the target of BCMA, CAR-T and ADC drugs They are already at the forefront and have entered the market
.
In the field of bispecific antibodies targeting BCMA, most of them are currently in the clinical development stage, but more and more data have also released a key signal.
The potential of bispecific antibodies should not be underestimated.
The ASH annual meeting in December last year The data shown above shows that bispecific antibodies can avoid some of the serious toxicity of CAR-T therapy, and by avoiding the need for continuous administration and hospitalization, it provides a more convenient dosage than the first-generation bispecific antibodies, or Become a competitor of CAR-T that cannot be ignored
.
Therefore, in the development of strategies for targeting BCMA to treat patients with MM, several BCMA/CD3 bispecific antibodies being developed by major companies are also very attractive, such as Pfizer, Amgen, Johnson & Johnson, AbbVie, and Regeneron Pharmaceutical factories have products under development
.
On February 11, 2019, American biotechnology giant AbbVie, TeneoBio and its subsidiary TeneoOne jointly announced that they will jointly develop the global development of the targeted BCMA/CD3 bispecific antibody TNB-383B for the treatment of multiple myeloma
.
Recommended reading: AbbVie raged $90 million to develop the BCMA/CD3 bispecific antibody.
Are you optimistic about it? | Yimaimeng broke the news in February 2021 that Pfizer's bispecific antibody PF-06863135 that targets BCMA and CD3 will start a key phase 2 trial.
The drug has been granted fast track by the U.
S.
Food and Drug Administration (FDA) Qualification (FTD)
.
The domestic layout of BCMA/CD3 double antibodies is not deserted.
Many companies report clinical progress or research trends: On August 17, 2020, Amgen/BeiGene CD3/BCMA bispecific antibody-AMG 701 was obtained in China Approved clinically for the treatment of relapsed/refractory multiple myeloma
.
On March 1, 2021, the clinical trial application of "Recombinant Humanized Anti-BCMA/CD3 Bispecific Antibody for Injection" declared by Shandong New Times Pharmaceutical Co.
, Ltd.
, a subsidiary of Lunan Pharmaceutical Group, was accepted
.
Recommended reading: The first domestic BCMA/CD3 bi-antibody clinical trial application is accepted, and the field of bi-antibody is dynamic Yimai Meng broke the news on June 3, 2021, a bi-antibody targeting CD3 and BCMA "EMB-06 injection" "The clinical trial application was accepted.
This is based on the double antibody produced by the proprietary FIT-Ig® (Fabs-In-Tandem immunoglobulin) technology of Anmai Biotechnology, which has been approved to initiate clinical trials in Australia
.
Recommended reading: The application for clinical trial of BCMA/CD3 double antibody of Anmai Bio has been accepted.
Yimai Meng broke the news that Connoa Bio CM336 injection recruits immune T cells to the target by specifically binding BCMA positive target cells and CD3 positive T cells Around the cell, T cells are activated, and T cell-mediated tumor cell killing (TDCC) is induced to kill target cells
.
According to the company's disclosure, CM336 has a higher affinity for tumor cells and has a stronger activity of inducing T cells to kill tumor cells
.
Reference materials: 1.
https:// -patients-with-relapsed-or-refractory-multiple-myeloma/2.
https:// /
S.
Food and Drug Administration (FDA) its biologics license for subcutaneous injection of bi-antibody therapy teclistamab Application (BLA)
.
The drug targets B cell maturation antigen (BCMA) and CD3, and is being developed for the treatment of relapsed or refractory (r/r) multiple myeloma
.
Multiple myeloma (MM) is the second most common hematological malignancy after non-Hodgkin's lymphoma and cannot be cured
.
In this disease, clonal plasma cells in the bone marrow deteriorate and abnormally proliferate.
Malignant plasma cells can replace normal blood cells in the body, leading to anemia and uncontrollable bleeding
.
It can also cause bone density and strength problems, and increase the risk of infection by reducing the body's immune response
.
In recent years, despite great progress in chemotherapy, proteasome inhibitors, and immunomodulator thalidomide derivatives, almost all patients will eventually relapse
.
Therefore, there is an urgent need for new treatment options
.
With the in-depth research on the disease biology and therapeutic targets of MM, some targeted therapies have shown good therapeutic effects
.
BCMA (B cell maturation antigen) is one of the important markers on the surface of mature B cells.
It is highly expressed on all MM cells and is not expressed in other normal tissues (except plasma cells).
Therefore, it has become a new treatment strategy for MM patients.
A very hot target in the middle
.
Teclistamab is a bispecific antibody developed using Genmab DuoBody® technology that can simultaneously target T cell CD3 and multiple myeloma (MM) cell BCMA
.
The role of Teclistamab is to make T cells with tumor-killing effect gather around MM cells expressing BCMA, so that T cells can be activated and redirected to kill BCMA-positive cancer cells
.
▲The mechanism of action of teclistamab (picture source: Janssen official website) BCMxCD3 double antibody has excellent overall remission rate To evaluate the safety and effectiveness of drugs in multiple myeloma
.
The latest clinical results published by ASH showed that among severely pretreated patients who received subcutaneous injection of teclistamab, the overall response rate (ORR) reached 62% (n=93/150), and the patients who achieved partial response (PR) were 58%, strictly speaking, 21% of patients achieved complete remission (CR)
.
At a median follow-up time of 9 months, 59% of patients had no disease progression after remission, and the cellular response deepened over time
.
“The deep expertise, creativity and perseverance of the entire Janssen R&D organization enable teclistamab to rapidly advance the treatment of multiple myeloma,” said Dr.
Mathai Mammen, global head of Janssen R&D at Johnson & Johnson.
“Today’s submission is our commitment to patients.
Another important step to bring truly transformative drugs, these drugs will have a profound impact on their health
.
"The double antibodies against BCMA cannot be ignored in the strategy of treating MM against the target of BCMA, CAR-T and ADC drugs They are already at the forefront and have entered the market
.
In the field of bispecific antibodies targeting BCMA, most of them are currently in the clinical development stage, but more and more data have also released a key signal.
The potential of bispecific antibodies should not be underestimated.
The ASH annual meeting in December last year The data shown above shows that bispecific antibodies can avoid some of the serious toxicity of CAR-T therapy, and by avoiding the need for continuous administration and hospitalization, it provides a more convenient dosage than the first-generation bispecific antibodies, or Become a competitor of CAR-T that cannot be ignored
.
Therefore, in the development of strategies for targeting BCMA to treat patients with MM, several BCMA/CD3 bispecific antibodies being developed by major companies are also very attractive, such as Pfizer, Amgen, Johnson & Johnson, AbbVie, and Regeneron Pharmaceutical factories have products under development
.
On February 11, 2019, American biotechnology giant AbbVie, TeneoBio and its subsidiary TeneoOne jointly announced that they will jointly develop the global development of the targeted BCMA/CD3 bispecific antibody TNB-383B for the treatment of multiple myeloma
.
Recommended reading: AbbVie raged $90 million to develop the BCMA/CD3 bispecific antibody.
Are you optimistic about it? | Yimaimeng broke the news in February 2021 that Pfizer's bispecific antibody PF-06863135 that targets BCMA and CD3 will start a key phase 2 trial.
The drug has been granted fast track by the U.
S.
Food and Drug Administration (FDA) Qualification (FTD)
.
The domestic layout of BCMA/CD3 double antibodies is not deserted.
Many companies report clinical progress or research trends: On August 17, 2020, Amgen/BeiGene CD3/BCMA bispecific antibody-AMG 701 was obtained in China Approved clinically for the treatment of relapsed/refractory multiple myeloma
.
On March 1, 2021, the clinical trial application of "Recombinant Humanized Anti-BCMA/CD3 Bispecific Antibody for Injection" declared by Shandong New Times Pharmaceutical Co.
, Ltd.
, a subsidiary of Lunan Pharmaceutical Group, was accepted
.
Recommended reading: The first domestic BCMA/CD3 bi-antibody clinical trial application is accepted, and the field of bi-antibody is dynamic Yimai Meng broke the news on June 3, 2021, a bi-antibody targeting CD3 and BCMA "EMB-06 injection" "The clinical trial application was accepted.
This is based on the double antibody produced by the proprietary FIT-Ig® (Fabs-In-Tandem immunoglobulin) technology of Anmai Biotechnology, which has been approved to initiate clinical trials in Australia
.
Recommended reading: The application for clinical trial of BCMA/CD3 double antibody of Anmai Bio has been accepted.
Yimai Meng broke the news that Connoa Bio CM336 injection recruits immune T cells to the target by specifically binding BCMA positive target cells and CD3 positive T cells Around the cell, T cells are activated, and T cell-mediated tumor cell killing (TDCC) is induced to kill target cells
.
According to the company's disclosure, CM336 has a higher affinity for tumor cells and has a stronger activity of inducing T cells to kill tumor cells
.
Reference materials: 1.
https:// -patients-with-relapsed-or-refractory-multiple-myeloma/2.
https:// /
