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Recent popular reports from Yimaike ★ Bluebird's share price soared by more than 14%, and the latest survey results show that lentiviral vectors do not induce cancer Yimai Meng broke the news ★ Treat rare diseases in children! Lentiviral gene therapy is recognized by the FDA as an advanced therapy for regenerative medicineMedMed broke the news on March 22, 2021/eMedClub News/--Recently, Atara Biotherapeutics, a T-cell immunotherapy company, will be on March 14-17, 2021.
At the 47th European Society of Blood and Bone Marrow Transplantation (EBMT 2021) meeting held on the daily, it was announced that its lead product tab-cel® (tabelecleucel, ATA129) was used to treat Epstein-Barr virus (EBV) after hematopoietic cell transplantation (HCT).
) Comprehensive analysis of 3 phase 2 studies of related lymphoproliferative diseases (EBV+ PTLD), and provides the latest long-term overall survival (OS) data.
The data results are positive, which will promote this "first-in-kind" allogeneic T-cell immunotherapy in the US and EU in the past two years.
Different from traditional CAR-T cell therapy, Atara's original spot-type T cell immunotherapy uses PBMCs (human peripheral blood mononuclear cells) from healthy people, and has precise targeting through genetic modification technology, and is a spot suitable for all kinds of people.
Type cytotoxic T cell therapy.
Atara's platform has the advantages of not requiring individual preparation, rapid amplification, and better safety and effectiveness.
Recommended reading: Atara's unique immune cell therapy enters Phase III clinical trials, and is expected to become the first "off-the-shelf" T cell product approved for marketingYimaihei Technology tab-cel® is currently under Atara's research and development progress The fastest T cell immunotherapy; in addition to EBV+PTLD patients after transplantation who failed rituximab treatment, it is also planned to be used for other EBV-related hematomas and solid tumors including nasopharyngeal carcinoma.
tab-cel® has launched Phase 3 clinical studies and is expected to become the first spot-type T cell immunotherapy product approved for marketing.
▲Data analysis results of Atara's pipeline (picture source: atarabio.
com) This analysis evaluated 2 tab-cel® completed single-arm Phase 2 studies (NCT00002663; NCT01498484), and 1 multi-center extended drug gift program ( EAP-201) study (NCT02822495) treatment remission data and OS data.
A comprehensive analysis of these 3 investigator-assessed phase 2 studies shows that tab-cel® can achieve a high overall remission rate and benefit in post-transplant EBV+PTLD patients who have failed rituximab therapy The long-term survival results; and whether it is complete remission (CR) or partial remission (PR), tab-cel® can provide similar long-term overall survival benefits.
Jakob Dupont, MD, Head of Global Research and Development at Atara, said: “Rituximab refractory patients who have EBV+ PTLD after hematopoietic cell transplantation have a poor prognosis.
The median overall survival is only a few months.
Time is for this high risk.
The population is critical.
"All patients in the study received tab-cel® at a dose of 2x10^6 cells/kg on the first, eighth and fifteenth days of each course of treatment.
Each course of treatment lasts for 35 days, and patients receive a median of 2 courses (range 1-5).
The data provided by Atara in the past preliminarily indicated that patients with EBV+ PTLD after transplantation showed clinical benefit to tab-cel® treatment.
The summary data provided on EBMT 2021 showed that of the 50 post-transplant EBV+ PTLD subjects who received tab-cel® treatment, the objective response rate (PR + CR) reached 62% (31/50), and 24 patients reached CR ( n = 24), 7 patients achieved PR.
The one-year survival rates of CR and PR patients were similar, 86.
7% and 85.
7%; the two-year survival rates were 81.
6% and 85.
7%, respectively.In terms of safety, tab-cel® treatment is generally well tolerated, and there is no evidence of treatment-related graft-versus-host disease (GVHD), cytokine release syndrome (CRS) or neurotoxicity.
▲tab-cel® (picture source: atarabio.
com) In addition, Atara also provides the results of multi-omics integrated analysis for tab-cel® activation.
Each part of the evaluation contributes to the establishment of tab-cel® therapeutic activity, mechanism of action and expansion characteristics.
According to the transcription data of tab-cel®, the activation characteristics of tab-cel® at the gene expression level, TCR recognition, and TCR enrichment of EBV infection-related diseases are consistent.
Pascal Touchon, President and CEO of Atara, said: “The tab-cel® data we provide today shows that the product features are consistent and clinically relevant to unrelated T cell donors, and have a high incidence of EBV+ PTLD patients after transplantation.
Overall remission rate and favorable long-term survival results.
Atara is committed to providing services to patients with a heavy burden of diseases and unmet needs, and is expected to complete the BLA application for PTLD indications in the United States in the third quarter of 2021, and in 2021 The MAA application was submitted in Europe in the fourth quarter.
"Recommended reading: The new "off-the-shelf" CAR-T is showing potential for the treatment of solid tumors, and the allogeneic strategy is the future development trend.
Yimai Meng broke the news of the Biopharmaceutical Innovation Technology Conference ( BPIT) will kick off in Shanghai from April 9th to 10th, 2021.
The four major conference venues will be exciting (click to view the focus topics).
Participants who successfully registered for the Shanghai 2021 BPIT conference will receive a limited edition of "CAR-T Cell Therapy Industry Research Report" 2021.
V3.
1 produced by Xingyao Research Institute under Medical Media.
At the 47th European Society of Blood and Bone Marrow Transplantation (EBMT 2021) meeting held on the daily, it was announced that its lead product tab-cel® (tabelecleucel, ATA129) was used to treat Epstein-Barr virus (EBV) after hematopoietic cell transplantation (HCT).
) Comprehensive analysis of 3 phase 2 studies of related lymphoproliferative diseases (EBV+ PTLD), and provides the latest long-term overall survival (OS) data.
The data results are positive, which will promote this "first-in-kind" allogeneic T-cell immunotherapy in the US and EU in the past two years.
Different from traditional CAR-T cell therapy, Atara's original spot-type T cell immunotherapy uses PBMCs (human peripheral blood mononuclear cells) from healthy people, and has precise targeting through genetic modification technology, and is a spot suitable for all kinds of people.
Type cytotoxic T cell therapy.
Atara's platform has the advantages of not requiring individual preparation, rapid amplification, and better safety and effectiveness.
Recommended reading: Atara's unique immune cell therapy enters Phase III clinical trials, and is expected to become the first "off-the-shelf" T cell product approved for marketingYimaihei Technology tab-cel® is currently under Atara's research and development progress The fastest T cell immunotherapy; in addition to EBV+PTLD patients after transplantation who failed rituximab treatment, it is also planned to be used for other EBV-related hematomas and solid tumors including nasopharyngeal carcinoma.
tab-cel® has launched Phase 3 clinical studies and is expected to become the first spot-type T cell immunotherapy product approved for marketing.
▲Data analysis results of Atara's pipeline (picture source: atarabio.
com) This analysis evaluated 2 tab-cel® completed single-arm Phase 2 studies (NCT00002663; NCT01498484), and 1 multi-center extended drug gift program ( EAP-201) study (NCT02822495) treatment remission data and OS data.
A comprehensive analysis of these 3 investigator-assessed phase 2 studies shows that tab-cel® can achieve a high overall remission rate and benefit in post-transplant EBV+PTLD patients who have failed rituximab therapy The long-term survival results; and whether it is complete remission (CR) or partial remission (PR), tab-cel® can provide similar long-term overall survival benefits.
Jakob Dupont, MD, Head of Global Research and Development at Atara, said: “Rituximab refractory patients who have EBV+ PTLD after hematopoietic cell transplantation have a poor prognosis.
The median overall survival is only a few months.
Time is for this high risk.
The population is critical.
"All patients in the study received tab-cel® at a dose of 2x10^6 cells/kg on the first, eighth and fifteenth days of each course of treatment.
Each course of treatment lasts for 35 days, and patients receive a median of 2 courses (range 1-5).
The data provided by Atara in the past preliminarily indicated that patients with EBV+ PTLD after transplantation showed clinical benefit to tab-cel® treatment.
The summary data provided on EBMT 2021 showed that of the 50 post-transplant EBV+ PTLD subjects who received tab-cel® treatment, the objective response rate (PR + CR) reached 62% (31/50), and 24 patients reached CR ( n = 24), 7 patients achieved PR.
The one-year survival rates of CR and PR patients were similar, 86.
7% and 85.
7%; the two-year survival rates were 81.
6% and 85.
7%, respectively.In terms of safety, tab-cel® treatment is generally well tolerated, and there is no evidence of treatment-related graft-versus-host disease (GVHD), cytokine release syndrome (CRS) or neurotoxicity.
▲tab-cel® (picture source: atarabio.
com) In addition, Atara also provides the results of multi-omics integrated analysis for tab-cel® activation.
Each part of the evaluation contributes to the establishment of tab-cel® therapeutic activity, mechanism of action and expansion characteristics.
According to the transcription data of tab-cel®, the activation characteristics of tab-cel® at the gene expression level, TCR recognition, and TCR enrichment of EBV infection-related diseases are consistent.
Pascal Touchon, President and CEO of Atara, said: “The tab-cel® data we provide today shows that the product features are consistent and clinically relevant to unrelated T cell donors, and have a high incidence of EBV+ PTLD patients after transplantation.
Overall remission rate and favorable long-term survival results.
Atara is committed to providing services to patients with a heavy burden of diseases and unmet needs, and is expected to complete the BLA application for PTLD indications in the United States in the third quarter of 2021, and in 2021 The MAA application was submitted in Europe in the fourth quarter.
"Recommended reading: The new "off-the-shelf" CAR-T is showing potential for the treatment of solid tumors, and the allogeneic strategy is the future development trend.
Yimai Meng broke the news of the Biopharmaceutical Innovation Technology Conference ( BPIT) will kick off in Shanghai from April 9th to 10th, 2021.
The four major conference venues will be exciting (click to view the focus topics).
Participants who successfully registered for the Shanghai 2021 BPIT conference will receive a limited edition of "CAR-T Cell Therapy Industry Research Report" 2021.
V3.
1 produced by Xingyao Research Institute under Medical Media.
