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We should be familiar with the strategy of using the tumor patient's own immune system to treat cancer, and the emergence of PD-1 monoclonal antibody therapy and Car-T therapy in previous years has given countless medical workers and cancer patients a shot in the arm, and its effect is so good that many patients with advanced cancer have an extra way
to survive when they are helpless.
However, with the deepening of research, it has been found that traditional monoclonal antibody drugs will be limited in therapeutic effect, the scope of application is narrow, and there is a possibility
of off-target effect.
In addition, the mechanism of tumor occurrence is very complex, and blocking multiple targets at the same time often has a better therapeutic effect, so bispecific antibodies have emerged
.
What are bispecific antibodies? Bispecific antibody, BsAb, abbreviated as biantibody, refers to artificial antibodies
that can specifically bind two antigens or epitopes at the same time.
Simply put, it is like a bridge connecting 2 antigens (epitopes), it is precisely because of this characteristic that its sensitivity and specificity are significantly better than traditional monoclonal antibody drugs, and to a certain extent, the side effects of off-target are reduced, it can be said that bispecific antibody therapy is a very potential tumor treatment
.
On December 13, 2022, the New England Journal of Medicine (NEJM) reported a new research advance in which researchers used a new treatment that allows the immune system to kill bone marrow cancer cells in a worldwide clinical trial, the results showed It has been successful in as many as 73% of patients, and the drug used in this study is the bispecific antibody Talquetamab
.
Multiple myeloma treated with Talquetamab is an incurable blood cancer that affects plasma cells
in the bone marrow.
When the tumor is malignant, these plasma cells spread rapidly and replace normal cells
in the bone marrow.
In 2020, an estimated 176,000 people worldwide were diagnosed with multiple myeloma
.
Some people diagnosed with multiple myeloma do not initially have any symptoms, and because the cancer is a progressive neoplastic disease, it is often accompanied by symptoms such as multiple osteolytic damage, hypercalcemia, and anemia as the disease progresses
.
Talquetamab is a T cell redirecting bispecific antibody that targets GPRC5D and CD3
.
CD3 is involved in activating T cells, while GPRC5D is highly expressed
on multiple myeloma cells.
The results of preclinical studies in mouse models showed that talquetamab induced T cell-mediated killing of GPRC5D-expressing multiple myeloma cells by recruiting and activating CD3-positive T cells and inhibited tumor formation and growth
.
In this study, the research team administered intravenous or subcutaneous injection of Talquetama to 232 patients, and as shown in Table 1, the characteristics of the patients' conditions were similar
.
At the same time, the results of the trial were very encouraging:
70% of patients receiving the dose level of 405 μg had a response, 57% had a very good partial response, and 23% had a complete response; Among patients receiving a dose level of 800 μg, 64% had a response, 52% had a very good partial response, and 23% had a complete response; The results are shown
in Figure 1.
Of the patients who received the most effective subcutaneous dose, 68% responded
.
Of the patients who received the most effective intravenous dose, 72% responded
.
Table 1: Patient characteristics Figure 3: Response to Talquetamab therapy in patients with relapsed or refractory multiple myeloma3
The median time to response was 0.
9 months in patients receiving a dose level of 405 μg and 1.
2 months
in patients receiving a dose level of 800 μg.
The median time to complete response or better was 9.
3 months in patients receiving a dose level of 405 μg and 2.
3 months
in patients receiving a dose level of 800 μg.
Most patients' responses deepen over time, and the results are shown
in Figure 2.
Figure II: Response over time in patients receiving the recommended dose of the Talquetamab Phase 2 study3Further,
the researchers studied the pharmacokinetics of the drug, Compared to intravenous injection, the concentration-time curve after subcutaneous injection shows fewer fluctuations and a longer lasting pattern with a lower peak-to-valley ratio (Figure 3).
Both doses recommended for the Phase 2 study had similar pharmacokinetic profiles at steady state, and serum exposure remained above the 90% maximum effective concentration in in vitro cytotoxicity assays, and these findings supported
both dose schedules.
Figure 3: Pharmacokinetics of Talquetamab3At
the same time, the research team also verified the safety of this new drug, and at the recommended dose in the Phase 2 study, discontinuation of treatment due to adverse events was rare Only one patient who received a dose of 800 μg of talquetamab reported discontinuation of treatment
.
The researchers believe that this withdrawal event is not related
to talquetamab.
Overall, Talquetamab is a new, readily available bispecific antibody against the novel target GPRC5D with substantial antitumor effects in patients with relapsed or refractory multiple myeloma who have undergone extensive pretreatment
。 On June 29 this year, the US FDA has granted the dual-specific antibody talquetab breakthrough therapy designation for the treatment of patients with relapsed or refractory multiple myeloma, as Dr.
Sen Zhuang, vice president of clinical research and development of Janssen, said: "Although there are other approved therapies for multiple myeloma, due to the heterogeneity of the disease affecting the treatment response of patients, the development of new targets and therapies is still very needed
.
" 。 Our goal is to cure diseases and try to give patients the best treatment, which is our unwavering mission
as we move towards scientific progress and the development of new treatments.
"
References: 1.
SONG Shuo,QIAN Yimin,WANG Ruonan,et al.
Structure-based design and mechanism of action of bispecific antibody products[J].
China Journal of Pharmaceutical Industry,2021,52(2):170-179.
) 2.
Rajkumar SV.
Multiple myeloma: 2020 update on diagnosis, risk-stratification and management.
Am J Hematol.
2020; 95(5):548-5672020; 95(5):548-567.
3.
Chari A, Minnema MC, Berdeja JG, et al.
Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma [published online ahead of print, 2022 Dec 10].
N Engl J Med.
2022; 10.
1056 Written by | Edited by | CICI
The articles reprinted by the "Yaodu" public account come from other public account platforms, and the main purpose is to share industry-related knowledge and transmit the latest information
.
The copyright of pictures and articles belongs to the original author, if there is any infringement, please inform in time, we will delete the relevant information
within 24 hours.
to survive when they are helpless.
However, with the deepening of research, it has been found that traditional monoclonal antibody drugs will be limited in therapeutic effect, the scope of application is narrow, and there is a possibility
of off-target effect.
In addition, the mechanism of tumor occurrence is very complex, and blocking multiple targets at the same time often has a better therapeutic effect, so bispecific antibodies have emerged
.
What are bispecific antibodies? Bispecific antibody, BsAb, abbreviated as biantibody, refers to artificial antibodies
that can specifically bind two antigens or epitopes at the same time.
Simply put, it is like a bridge connecting 2 antigens (epitopes), it is precisely because of this characteristic that its sensitivity and specificity are significantly better than traditional monoclonal antibody drugs, and to a certain extent, the side effects of off-target are reduced, it can be said that bispecific antibody therapy is a very potential tumor treatment
.
On December 13, 2022, the New England Journal of Medicine (NEJM) reported a new research advance in which researchers used a new treatment that allows the immune system to kill bone marrow cancer cells in a worldwide clinical trial, the results showed It has been successful in as many as 73% of patients, and the drug used in this study is the bispecific antibody Talquetamab
.
Multiple myeloma treated with Talquetamab is an incurable blood cancer that affects plasma cells
in the bone marrow.
When the tumor is malignant, these plasma cells spread rapidly and replace normal cells
in the bone marrow.
In 2020, an estimated 176,000 people worldwide were diagnosed with multiple myeloma
.
Some people diagnosed with multiple myeloma do not initially have any symptoms, and because the cancer is a progressive neoplastic disease, it is often accompanied by symptoms such as multiple osteolytic damage, hypercalcemia, and anemia as the disease progresses
.
Talquetamab is a T cell redirecting bispecific antibody that targets GPRC5D and CD3
.
CD3 is involved in activating T cells, while GPRC5D is highly expressed
on multiple myeloma cells.
The results of preclinical studies in mouse models showed that talquetamab induced T cell-mediated killing of GPRC5D-expressing multiple myeloma cells by recruiting and activating CD3-positive T cells and inhibited tumor formation and growth
.
In this study, the research team administered intravenous or subcutaneous injection of Talquetama to 232 patients, and as shown in Table 1, the characteristics of the patients' conditions were similar
.
At the same time, the results of the trial were very encouraging:
70% of patients receiving the dose level of 405 μg had a response, 57% had a very good partial response, and 23% had a complete response; Among patients receiving a dose level of 800 μg, 64% had a response, 52% had a very good partial response, and 23% had a complete response; The results are shown
in Figure 1.
Of the patients who received the most effective subcutaneous dose, 68% responded
.
Of the patients who received the most effective intravenous dose, 72% responded
.
Table 1: Patient characteristics Figure 3: Response to Talquetamab therapy in patients with relapsed or refractory multiple myeloma3
The median time to response was 0.
9 months in patients receiving a dose level of 405 μg and 1.
2 months
in patients receiving a dose level of 800 μg.
The median time to complete response or better was 9.
3 months in patients receiving a dose level of 405 μg and 2.
3 months
in patients receiving a dose level of 800 μg.
Most patients' responses deepen over time, and the results are shown
in Figure 2.
Figure II: Response over time in patients receiving the recommended dose of the Talquetamab Phase 2 study3Further,
the researchers studied the pharmacokinetics of the drug, Compared to intravenous injection, the concentration-time curve after subcutaneous injection shows fewer fluctuations and a longer lasting pattern with a lower peak-to-valley ratio (Figure 3).
Both doses recommended for the Phase 2 study had similar pharmacokinetic profiles at steady state, and serum exposure remained above the 90% maximum effective concentration in in vitro cytotoxicity assays, and these findings supported
both dose schedules.
Figure 3: Pharmacokinetics of Talquetamab3At
the same time, the research team also verified the safety of this new drug, and at the recommended dose in the Phase 2 study, discontinuation of treatment due to adverse events was rare Only one patient who received a dose of 800 μg of talquetamab reported discontinuation of treatment
.
The researchers believe that this withdrawal event is not related
to talquetamab.
Overall, Talquetamab is a new, readily available bispecific antibody against the novel target GPRC5D with substantial antitumor effects in patients with relapsed or refractory multiple myeloma who have undergone extensive pretreatment
。 On June 29 this year, the US FDA has granted the dual-specific antibody talquetab breakthrough therapy designation for the treatment of patients with relapsed or refractory multiple myeloma, as Dr.
Sen Zhuang, vice president of clinical research and development of Janssen, said: "Although there are other approved therapies for multiple myeloma, due to the heterogeneity of the disease affecting the treatment response of patients, the development of new targets and therapies is still very needed
.
" 。 Our goal is to cure diseases and try to give patients the best treatment, which is our unwavering mission
as we move towards scientific progress and the development of new treatments.
"
References: 1.
SONG Shuo,QIAN Yimin,WANG Ruonan,et al.
Structure-based design and mechanism of action of bispecific antibody products[J].
China Journal of Pharmaceutical Industry,2021,52(2):170-179.
) 2.
Rajkumar SV.
Multiple myeloma: 2020 update on diagnosis, risk-stratification and management.
Am J Hematol.
2020; 95(5):548-5672020; 95(5):548-567.
3.
Chari A, Minnema MC, Berdeja JG, et al.
Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma [published online ahead of print, 2022 Dec 10].
N Engl J Med.
2022; 10.
1056 Written by | Edited by | CICI
disclaimer
The articles reprinted by the "Yaodu" public account come from other public account platforms, and the main purpose is to share industry-related knowledge and transmit the latest information
.
The copyright of pictures and articles belongs to the original author, if there is any infringement, please inform in time, we will delete the relevant information
within 24 hours.
