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News from May 16, 2021 /bioon.
com" target="_blank">/ --Tessa Therapeutics is an international biotechnology company headquartered in Singapore, dedicated to the development of next-generation cell therapies for the treatment of cancer.
Recently, the company announced the early clinical results of "universal" T cell therapy (TT11X) at the 24th American Society for Gene and Cell Therapy Annual Meeting (ASGCT 2021) in 2021 .
bioon.com" target="_blank">/ --Tessa Therapeutics is an international biotechnology company headquartered in Singapore, dedicated to the development of next-generation cell therapies for the treatment of cancer.
Recently, the company announced the early clinical results of "universal" T cell therapy (TT11X) at the 24th American Society for Gene and Cell Therapy Annual Meeting (ASGCT 2021) in 2021 .
com" target="_blank">"Universal" T cell therapy (TT11X)
TT11X is an allogeneic, CD30 chimeric antigen receptor, and Epstein-Barr virus-specific T cell therapy (allogeneic CD30-CAR EBVST) , which is being jointly developed by Baylor College of Medicine in the United States and Tesha Biology.
Data released at the meeting From an ongoing Phase 1 dose escalation study (NCT04288726).
The study is evaluating TT11X for the treatment of patients with CD30-positive (CD30+) lymphoma.
TT11X is an allogeneic, CD30 chimeric antigen receptor, EB virus specific T cell therapy (allogeneic CD30-CAR EBVST)Data released at the meeting From an ongoing Phase 1 dose escalation study (NCT04288726).
The study is evaluating TT11X for the treatment of patients with CD30-positive (CD30+) lymphoma.
The data of 6 patients treated with TT11X were announced at the meeting.
The results showed that TT11X showed good safety in patients with relapsed or refractory (R/R) CD30+ lymphoma who had been heavily pre-treated (that is, had previously received multiple therapies), even at low doses The level also shows encouraging clinical activity.
The data set includes 3 cases receiving the lowest dose level (4 × 10E7 CD30-CAR EBVST) and 3 cases receiving the second dose level (1 × 10E8 CD30-CAR EBVST).
The results showed that TT11X showed good safety in patients with relapsed or refractory (R/R) CD30+ lymphoma who had been heavily pre-treated (that is, had previously received multiple therapies), even at low doses The level also shows encouraging clinical activity.
The data set includes 3 cases receiving the lowest dose level (4 × 10E7 CD30-CAR EBVST) and 3 cases receiving the second dose level (1 × 10E8 CD30-CAR EBVST).
png" target="_blank">
png" target="_blank">"Universal" allogeneic CD30-CAR EBVST cell therapy
The main findings are summarized as follows: (1) No serious adverse events or dose-limiting toxicity , including no evidence of graft-versus-host disease (GVHD), cytokine release syndrome (CRS) or neurotoxic syndrome.
(2) Among the 5 patients with evaluable efficacy, 3 patients have observed disease control and all have partial remission, that is, the overall remission rate (ORR) is 60% (3/5) .
No serious adverse events or dose-limiting toxicity overall response rate (ORR) is 60% (3/5)(2) Among the 5 patients with evaluable efficacy, 3 patients have observed disease control and all have partial remission, that is, the overall remission rate (ORR) is 60% (3/5) .
This phase 1 study aims to enroll 12-18 patients into 3 dose-escalation levels (4 × 10E7, 1 × 10E8, 4 × 10E8 CD30-CAR EBVST), and the last group is the same as those used in Tessa’s autologous CD30 project.
The dose levels are roughly equivalent.
It is expected to report the full results of the study by the end of 2021.
The dose levels are roughly equivalent.
It is expected to report the full results of the study by the end of 2021.
Dr.
Carlos Ramos, the lead investigator of the study and professor of the Cell and bioon.
com/genetherapy/" target="_blank">Gene Therapy Center at Baylor College of Medicine , said: "We are encouraged by the early data generated by this study.
TT11X is well tolerated and there is no evidence of GVHD or any serious adverse events.
The clinical activity is encouraging.
Although these are preliminary results, the data collected from the first 5 patients indicate that the allogeneic CD30-CAR EBVST may be able to overcome the common safety and tolerability challenges of allogeneic cell therapy.
We look forward to it.
We will complete the enrollment of this trial and further develop our understanding of this potential new bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor treatment platform.
"
bioon. Carlos Ramos, the lead investigator of the study and professor of the Cell and bioon.
com/genetherapy/" target="_blank">Gene Therapy Center at Baylor College of Medicine , said: "We are encouraged by the early data generated by this study.
TT11X is well tolerated and there is no evidence of GVHD or any serious adverse events.
The clinical activity is encouraging.
Although these are preliminary results, the data collected from the first 5 patients indicate that the allogeneic CD30-CAR EBVST may be able to overcome the common safety and tolerability challenges of allogeneic cell therapy.
We look forward to it.
We will complete the enrollment of this trial and further develop our understanding of this potential new bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor treatment platform.
"
com/genetherapy/" target="_blank">Gene therapy bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor
Jeffrey H.
Buchalter, President and Chief Executive Officer of Tesa Biology, said: "This is early but very important data to support Tesa Biology's development of'universal' allogeneic cell therapy.
We believe that our allogeneic CD30 -The CAR EBVST platform has great potential.
We are still committed to our long-term plan to develop this platform to address the major needs in the field of hematological malignancies and solid bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors .
"
bioon. Buchalter, President and Chief Executive Officer of Tesa Biology, said: "This is early but very important data to support Tesa Biology's development of'universal' allogeneic cell therapy.
We believe that our allogeneic CD30 -The CAR EBVST platform has great potential.
We are still committed to our long-term plan to develop this platform to address the major needs in the field of hematological malignancies and solid bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors .
"
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
Malcolm K.
Brenner, the scientific co-founder of Tessa Biotech, is a member of the American Academy of Medical Sciences and the founding leader of the Baylor College of Medicine (BCM) Cell and bioon.
com/genetherapy/" target="_blank">Gene Therapy Center (CAGT).
Based on the research and development of the unique characteristics of Virus Specific T-cell (VST) by Dr.
Malcolm Brenner and the Baylor College of Medicine team for decades , tesa is developing a proprietary allogeneic cell therapy platform .
bioon. Brenner, the scientific co-founder of Tessa Biotech, is a member of the American Academy of Medical Sciences and the founding leader of the Baylor College of Medicine (BCM) Cell and bioon.
com/genetherapy/" target="_blank">Gene Therapy Center (CAGT).
Based on the research and development of the unique characteristics of Virus Specific T-cell (VST) by Dr.
Malcolm Brenner and the Baylor College of Medicine team for decades , tesa is developing a proprietary allogeneic cell therapy platform .
com/genetherapy/" target="_blank">Gene therapy virus specific T-cell (Virus Specific T-cell, VST)
VST is a highly specialized T cell that has the ability to recognize and kill infected cells, while activating other parts of the immune system to coordinate responses.
The allogeneic VST without any form of genetic modification showed strong safety and effectiveness in early trials, and showed a minimized risk of GVHD.
Preclinical studies have further proved that targeting CD30 has the potential to help increase the expansion and persistence of allogeneic cells.
Through this platform approach, tesa's goal is to overcome the current challenges faced by allogeneic cell therapy and create a more effective, reliable and scalable treatment method for a wide range of cancers.
VST is a highly specialized T cell that has the ability to recognize and kill infected cells, while activating other parts of the immune system to coordinate responses. The allogeneic VST without any form of genetic modification showed strong safety and effectiveness in early trials, and showed a minimized risk of GVHD.
Preclinical studies have further proved that targeting CD30 has the potential to help increase the expansion and persistence of allogeneic cells.
Through this platform approach, tesa's goal is to overcome the current challenges faced by allogeneic cell therapy and create a more effective, reliable and scalable treatment method for a wide range of cancers.
png" target="_blank">
png" target="_blank">Autologous CD30 CAR-T cell therapy
In addition to allogeneic cell therapy, Tesha Biology is also developing a number of autologous therapies.
The lead asset in the company’s pipeline, TT11, is an autologous CD30 CAR-T cell therapy that is currently being developed for the treatment of relapsed or refractory classic Hodgkin’s lymphoma (cHL, phase 1 clinical) and CD30-positive non-Hodgkin’s lymphoma Lymphoma (NHL, Phase 2 clinical).
Prior to this, TT11 has been granted the bioon.
com/course_video/zai-sheng-yi-xue-qi-guan-yi-zhi-fei-zhan199245.
html">regenerative medicine advanced therapy (RMAT) qualification by the US bioon.
com/fda/" target="_blank">FDA and the priority drug qualification (PRIME) by the European Union EMA.
bioon.
com/course_video/zai-sheng-yi-xue-qi-guan-yi-zhi-fei-zhan199245.
html">
bioon. The lead asset in the company’s pipeline, TT11, is an autologous CD30 CAR-T cell therapy that is currently being developed for the treatment of relapsed or refractory classic Hodgkin’s lymphoma (cHL, phase 1 clinical) and CD30-positive non-Hodgkin’s lymphoma Lymphoma (NHL, Phase 2 clinical).
Prior to this, TT11 has been granted the bioon.
com/course_video/zai-sheng-yi-xue-qi-guan-yi-zhi-fei-zhan199245.
html">regenerative medicine advanced therapy (RMAT) qualification by the US bioon.
com/fda/" target="_blank">FDA and the priority drug qualification (PRIME) by the European Union EMA.
bioon.
com/course_video/zai-sheng-yi-xue-qi-guan-yi-zhi-fei-zhan199245.
html">
com/fda/" target="_blank">FDA bioon.
com/course_video/zai-sheng-yi-xue-qi-guan-yi-zhi-fei-zhan199245.
html">Regenerative Medicine
In bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials , TT11 has significant efficacy, good safety, and very limited toxicity in R/R cHL patients who have previously received multiple regimens, and can meaningfully solve the current treatment of R/R cHL.
Unmet medical needs.
bioon. com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials , TT11 has significant efficacy, good safety, and very limited toxicity in R/R cHL patients who have previously received multiple regimens, and can meaningfully solve the current treatment of R/R cHL.
Unmet medical needs.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials
Data from two phase 1/2 bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials (NCT02917083, NCT02690545) showed that in patients with R/R cHL who had previously received multiple regimens of treatment, at the highest dose level, about 60% of the bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors disappeared completely.
In addition, TT11 has good safety, very limited toxicity, and does not have the serious toxicity associated with several other CAR-T cell therapies that have been marketed.
TT11 has the potential to meaningfully solve the current unmet medical needs in the treatment of R/R cHL.
()
bioon. com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials (NCT02917083, NCT02690545) showed that in patients with R/R cHL who had previously received multiple regimens of treatment, at the highest dose level, about 60% of the bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors disappeared completely.
In addition, TT11 has good safety, very limited toxicity, and does not have the serious toxicity associated with several other CAR-T cell therapies that have been marketed.
TT11 has the potential to meaningfully solve the current unmet medical needs in the treatment of R/R cHL.
()
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical trial bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor
Original source: Tessa Therapeutics Announces Positive, Topline Data from Ongoing Phase 1 Trial of Allogeneic, “Off-the-Shelf” Cell Therapy, in Patients with Relapsed or Refractory CD30-Positive Lymphoma
