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Recent popular reports from Yimaike ★ Genxi Biology announced at the AACR annual meeting the long-term follow-up data of the universal allogeneic CAR-T therapy GC027 developed based on TruUCAR for r/r T-ALL.
Genxi Biology appoints the field of gene and cell therapy Senior expert Dr.
Yajin Ni is the company’s chief technology officer.
May 21, 2021/eMedClub News/--Suzhou, China; Palo Alto, California, U.
S.
, May 21, 2021-- Genxi Biotech Group (NAS DAQ: GRCL; referred to as "Genxi Bio"), a global clinical-stage biopharmaceutical company dedicated to the development of efficient and economical cell therapies for cancer treatment, recently announced that it will be in the 2021 American Society of Clinical Oncology (ASCO) year During the meeting and the European Hematology Association (EHA) conference in 2021, the latest clinical research results of a multi-center, first human trial on GC012F in the treatment of relapsed/refractory multiple myeloma will be published.
GC012F is a BCMA/CD19 dual-targeting autologous CAR-T cell therapy developed based on the FasTCAR patented technology platform of Genxi Biotech.
It has the advantage of "production can be completed the next day".
Currently, the candidate product is being evaluated in a phase I clinical trial initiated by the investigator.
As of January 12, 2021, the three dose groups of the study included a total of 19 patients with multiple myeloma, of which the highest dose level was 3×105 cells/kg body weight.
The above patients are all eligible for recurrence after multiple rounds of treatment.
Refractory standards.
Follow-up (after the ASH annual meeting in 2020) enrolled patients, all received the highest dose level of treatment.
The early objective response rate (ORR) was as high as 94.
7% (18/19), and all responses showed excellent partial response (VGPR) or even complete response (sCR) in the strict sense; data for all dose groups were presented A quick, in-depth, and long-lasting treatment effect.All patients (n=9) who received treatment in the highest dose group achieved minimal residual disease negative-strictly complete remission (MRD-sCR).
Of the 19 patients, 18 (94.
7%) belonged to the high-risk patients defined in the mSMART 3.
0 guidelines, and the median number of previous treatment lines for the patients was 5.
94.
7% (18/19) of patients had triple exposure to PI, IMiD, and at least a third treatment option, including anti-CD38 targeted therapy.
The safety of GC012F is consistent with previous observations.
The main occurrence is low-grade cytokine release syndrome (CRS) (84% of patients are grade 1/2; 11% of (n=2) patients are grade 3).
There was no grade 4 or grade 5 CRS; no immune effector cell-related neurotoxicity (ICANS) was observed in any of the 19 patients.
Adverse events (TEAEs) that occurred during treatment were mainly manifested as a decrease in blood cell count and an increase in AST.
All TEAEs were relieved after standard treatment.
The study will continue to evaluate the effectiveness and safety of GC012F in the treatment of patients.
"I am very pleased to see the mutual corroboration between the follow-up of the initial enrolled patients and the subsequent treatment effect of the enrolled patients.
It not only confirms the research results we announced at the ASH annual meeting last year, but also further clarifies the GC012F dual-targeting autologous CAR -The excellent safety and effectiveness of T cell therapy, including for high-risk patients.
" Dr.
Martina Sersch, Chief Medical Officer of Genxi Biotech, said: "High-risk patients are usually extremely difficult to treat, and all patients in the highest dose group in this study reached MRD-negative sCR status, and maintained a deep response six months or longer after receiving GC012F infusion.
The
above exciting research data is for high-risk patients (including patients who do not respond to standard treatment regimens or who do not continue to respond.
) Brings new hope.
Next, we plan to promote this research on a global scale, including promoting it as a more priority treatment option.
Looking forward to sharing more developments with you in the near future.
"The clinical research (IIT) co-lead researcher initiated by the GC012F investigator, Professor Du Juan from Shanghai Changzheng Hospital, said: "Multiple myeloma (MM) is a very difficult to treat hematological malignant tumor.
There are about 750,000 multiple myeloma patients in the world¹, and about 160,000 new patients² are newly added every year², and the trend is increasing year by year.
Among them, high-risk patients account for 20%-30%³, usually with a poor prognosis, accompanied by a higher risk of early recurrence, shorter progression-free survival and overall survival.
This time, we are pleased to see that Genxi's BCMA/CD19 dual-targeted autologous CAR-T cell therapy GC012F has shown excellent efficacy and safety in the long-term follow-up results of patients with relapsed/refractory multiple myeloma ; And thanks to the advantages of the FasTCAR platform, it significantly shortens the waiting time for clinical treatment and ignites the hope of life for more patients.
Professor Fu Weijun of Shanghai Changzheng Hospital, the co-lead investigator of the clinical study (IIT) initiated by the GC012F investigator, said: "It is great to see that we announced the first human trial data of GC012F in the form of an oral report at the ASH meeting last year.
The research has made positive progress again, and the previous results have been further verified; this also allows us to see the good application prospects of Genxi Bio's FasTCAR platform and Dual CAR technology.
With the continuous deepening of research, this innovative BCMA/CD19 dual-targeting autologous CAR-T cell therapy is continuously showing clinical benefits for patients with multiple myeloma, especially high-risk patients.
I look forward to this research.
Continue to achieve more results and strive to meet the urgent treatment needs of patients with relapsed/refractory multiple myeloma as soon as possible. "ASCO 2021EHA 2021 e-poster details are as follows: 2021 American Society of Clinical Oncology (ASCO) Annual Meeting Abstract 8014: BCMA/CD19 dual-targeting CAR-T cell therapy GC012F based on the FasTCAR platform to treat relapsed or refractory multiple Poster of the long-term follow-up results of the first multi-center human trial of myeloma patients.
Release date: June 4, 2021.
2021 European Hematology Association (EHA2021) Conference Abstract EP962: BCMA/CD19 dual-targeted CAR-T developed based on the FasTCAR platform Long-term follow-up results of the first multi-center human trial of cell therapy GC012F in the treatment of patients with relapsed or refractory multiple myeloma.
Poster release date: June 11, 2021.
Multiple myeloma (MM) is the most common in the United States The third largest hematological malignancy in China, its tumor cells originate from bone marrow plasma cells, an immune cell responsible for secreting anti-infective antibodies.
About 160,000 patients worldwide are diagnosed with multiple myeloma each year; in 2020, the United States is expected to be diagnosed There are more than 32,000 patients.
In recent years, although many advances have been made in the treatment of multiple myeloma, the clinical treatment effect is still not satisfactory.
International Myeloma Working Group (IMWG) and Mayo myeloma analysis Standards such as Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines classify patients with multiple myeloma with specific cytogenetic or other abnormalities as high-risk patients.
This part of the population has multiple occurrences in all The proportion of patients with myeloma is 20-30%.
High-risk patients have a high risk of early recurrence, progression-free survival and short overall survival.
Patients with multiple myeloma are considered to be the most difficult to treat and usually have a poor prognosis.
About GC012FGC012F is a dual-targeted autologous CAR-T therapy candidate product developed based on the FasTCAR platform.
At present, the candidate product is being evaluated in a multi-center, phase I clinical trial initiated by the investigator for its safety and effectiveness in the treatment of multiple myeloma, covering multiple domestic research centers.
GC012F simultaneously targets the sites of malignant plasma cells expressing BCMA and the sites of early progenitor cells expressing CD19, bringing rapid, in-depth and long-lasting therapeutic effects to patients with multiple myeloma.
About FasTCARFasTCAR is a technology platform of Genxi Biotech with intellectual property rights, aiming to develop high-quality autologous CAR-T cell therapy.
Pre-clinical studies have shown that CAR-T cells produced through the FasTCAR technology platform have a younger phenotype, lower exhaustion, and enhanced expansion capacity, persistence, bone marrow migration ability, and tumor cell clearance activity.
With the advantage of "complete production next day", FasTCAR platform technology can greatly improve cell production efficiency, thereby significantly reducing production costs, and enabling cell therapy to benefit more cancer patients.
About Genxi Biotech Genxi Biotechnology Group (referred to as "Genxi Bio") is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies.
Utilizing its pioneering FasTCAR and TruUCAR technology platforms, Genxi Bio is developing a number of autologous and allogeneic rich clinical-stage cancer treatment product pipelines.
These products are expected to overcome the major industry challenges that continue to exist in traditional CAR-T therapy, including long production time, poor production quality, high treatment costs, and lack of effective treatment for solid tumors.
To learn more about GracellBio, please visit www.
gracellbio.
com/Follow LinkedIn account @GracellBio.
Cautionary Statement Regarding Forward-Looking Statements The statements in this press release regarding future expectations, plans, prospects, and other non-historical facts may include those defined under the Private Securities Litigation Reform Act of 1995 "Forward-looking Statement".
These statements include, but are not limited to, statements related to the expected transaction and completion time of this issuance.
These statements may but not necessarily contain the following vocabulary and the corresponding negative or similar vocabulary: purpose, expectation, belief, estimation, prediction, prediction, plan, possibility, prospect, plan, potential, speculation, drafting, seeking, possible , Should, will.
Due to various important factors, actual results may differ materially from forward-looking statements, and there is no guarantee that any forward-looking statements will be realized.
These important factors include the factors mentioned in the "Risk Factors" section of the Form 20-F of Genxi Biotech’s recent annual report, as well as the potential risks, uncertainties and other important factors in the subsequent submission of Genxi Biologics to the US Securities Regulatory Commission.
Discussion of factors.
Any forward-looking statements in this statement only reflect current expectations, and Genxi Biotech is not responsible for publicly updating or reviewing any forward-looking statements, whether based on new information, future events or other reasons.
Readers are requested not to rely on forward-looking statements after the publication date of this press release.
[1]https://imf-d8-prod.
s3.
us-west-1.
wasabisys.
com/resource/patient-handbook.
pdf[2]Ludwig H, et al.
Oncologist.
2020 Sep;25(9) :e1406-e1413[3]Management of Newly Diagnosed Symptomatic Multiple Myeloma: updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) Consensus Guidelines
Genxi Biology appoints the field of gene and cell therapy Senior expert Dr.
Yajin Ni is the company’s chief technology officer.
May 21, 2021/eMedClub News/--Suzhou, China; Palo Alto, California, U.
S.
, May 21, 2021-- Genxi Biotech Group (NAS DAQ: GRCL; referred to as "Genxi Bio"), a global clinical-stage biopharmaceutical company dedicated to the development of efficient and economical cell therapies for cancer treatment, recently announced that it will be in the 2021 American Society of Clinical Oncology (ASCO) year During the meeting and the European Hematology Association (EHA) conference in 2021, the latest clinical research results of a multi-center, first human trial on GC012F in the treatment of relapsed/refractory multiple myeloma will be published.
GC012F is a BCMA/CD19 dual-targeting autologous CAR-T cell therapy developed based on the FasTCAR patented technology platform of Genxi Biotech.
It has the advantage of "production can be completed the next day".
Currently, the candidate product is being evaluated in a phase I clinical trial initiated by the investigator.
As of January 12, 2021, the three dose groups of the study included a total of 19 patients with multiple myeloma, of which the highest dose level was 3×105 cells/kg body weight.
The above patients are all eligible for recurrence after multiple rounds of treatment.
Refractory standards.
Follow-up (after the ASH annual meeting in 2020) enrolled patients, all received the highest dose level of treatment.
The early objective response rate (ORR) was as high as 94.
7% (18/19), and all responses showed excellent partial response (VGPR) or even complete response (sCR) in the strict sense; data for all dose groups were presented A quick, in-depth, and long-lasting treatment effect.All patients (n=9) who received treatment in the highest dose group achieved minimal residual disease negative-strictly complete remission (MRD-sCR).
Of the 19 patients, 18 (94.
7%) belonged to the high-risk patients defined in the mSMART 3.
0 guidelines, and the median number of previous treatment lines for the patients was 5.
94.
7% (18/19) of patients had triple exposure to PI, IMiD, and at least a third treatment option, including anti-CD38 targeted therapy.
The safety of GC012F is consistent with previous observations.
The main occurrence is low-grade cytokine release syndrome (CRS) (84% of patients are grade 1/2; 11% of (n=2) patients are grade 3).
There was no grade 4 or grade 5 CRS; no immune effector cell-related neurotoxicity (ICANS) was observed in any of the 19 patients.
Adverse events (TEAEs) that occurred during treatment were mainly manifested as a decrease in blood cell count and an increase in AST.
All TEAEs were relieved after standard treatment.
The study will continue to evaluate the effectiveness and safety of GC012F in the treatment of patients.
"I am very pleased to see the mutual corroboration between the follow-up of the initial enrolled patients and the subsequent treatment effect of the enrolled patients.
It not only confirms the research results we announced at the ASH annual meeting last year, but also further clarifies the GC012F dual-targeting autologous CAR -The excellent safety and effectiveness of T cell therapy, including for high-risk patients.
" Dr.
Martina Sersch, Chief Medical Officer of Genxi Biotech, said: "High-risk patients are usually extremely difficult to treat, and all patients in the highest dose group in this study reached MRD-negative sCR status, and maintained a deep response six months or longer after receiving GC012F infusion.
The
above exciting research data is for high-risk patients (including patients who do not respond to standard treatment regimens or who do not continue to respond.
) Brings new hope.
Next, we plan to promote this research on a global scale, including promoting it as a more priority treatment option.
Looking forward to sharing more developments with you in the near future.
"The clinical research (IIT) co-lead researcher initiated by the GC012F investigator, Professor Du Juan from Shanghai Changzheng Hospital, said: "Multiple myeloma (MM) is a very difficult to treat hematological malignant tumor.
There are about 750,000 multiple myeloma patients in the world¹, and about 160,000 new patients² are newly added every year², and the trend is increasing year by year.
Among them, high-risk patients account for 20%-30%³, usually with a poor prognosis, accompanied by a higher risk of early recurrence, shorter progression-free survival and overall survival.
This time, we are pleased to see that Genxi's BCMA/CD19 dual-targeted autologous CAR-T cell therapy GC012F has shown excellent efficacy and safety in the long-term follow-up results of patients with relapsed/refractory multiple myeloma ; And thanks to the advantages of the FasTCAR platform, it significantly shortens the waiting time for clinical treatment and ignites the hope of life for more patients.
Professor Fu Weijun of Shanghai Changzheng Hospital, the co-lead investigator of the clinical study (IIT) initiated by the GC012F investigator, said: "It is great to see that we announced the first human trial data of GC012F in the form of an oral report at the ASH meeting last year.
The research has made positive progress again, and the previous results have been further verified; this also allows us to see the good application prospects of Genxi Bio's FasTCAR platform and Dual CAR technology.
With the continuous deepening of research, this innovative BCMA/CD19 dual-targeting autologous CAR-T cell therapy is continuously showing clinical benefits for patients with multiple myeloma, especially high-risk patients.
I look forward to this research.
Continue to achieve more results and strive to meet the urgent treatment needs of patients with relapsed/refractory multiple myeloma as soon as possible. "ASCO 2021EHA 2021 e-poster details are as follows: 2021 American Society of Clinical Oncology (ASCO) Annual Meeting Abstract 8014: BCMA/CD19 dual-targeting CAR-T cell therapy GC012F based on the FasTCAR platform to treat relapsed or refractory multiple Poster of the long-term follow-up results of the first multi-center human trial of myeloma patients.
Release date: June 4, 2021.
2021 European Hematology Association (EHA2021) Conference Abstract EP962: BCMA/CD19 dual-targeted CAR-T developed based on the FasTCAR platform Long-term follow-up results of the first multi-center human trial of cell therapy GC012F in the treatment of patients with relapsed or refractory multiple myeloma.
Poster release date: June 11, 2021.
Multiple myeloma (MM) is the most common in the United States The third largest hematological malignancy in China, its tumor cells originate from bone marrow plasma cells, an immune cell responsible for secreting anti-infective antibodies.
About 160,000 patients worldwide are diagnosed with multiple myeloma each year; in 2020, the United States is expected to be diagnosed There are more than 32,000 patients.
In recent years, although many advances have been made in the treatment of multiple myeloma, the clinical treatment effect is still not satisfactory.
International Myeloma Working Group (IMWG) and Mayo myeloma analysis Standards such as Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines classify patients with multiple myeloma with specific cytogenetic or other abnormalities as high-risk patients.
This part of the population has multiple occurrences in all The proportion of patients with myeloma is 20-30%.
High-risk patients have a high risk of early recurrence, progression-free survival and short overall survival.
Patients with multiple myeloma are considered to be the most difficult to treat and usually have a poor prognosis.
About GC012FGC012F is a dual-targeted autologous CAR-T therapy candidate product developed based on the FasTCAR platform.
At present, the candidate product is being evaluated in a multi-center, phase I clinical trial initiated by the investigator for its safety and effectiveness in the treatment of multiple myeloma, covering multiple domestic research centers.
GC012F simultaneously targets the sites of malignant plasma cells expressing BCMA and the sites of early progenitor cells expressing CD19, bringing rapid, in-depth and long-lasting therapeutic effects to patients with multiple myeloma.
About FasTCARFasTCAR is a technology platform of Genxi Biotech with intellectual property rights, aiming to develop high-quality autologous CAR-T cell therapy.
Pre-clinical studies have shown that CAR-T cells produced through the FasTCAR technology platform have a younger phenotype, lower exhaustion, and enhanced expansion capacity, persistence, bone marrow migration ability, and tumor cell clearance activity.
With the advantage of "complete production next day", FasTCAR platform technology can greatly improve cell production efficiency, thereby significantly reducing production costs, and enabling cell therapy to benefit more cancer patients.
About Genxi Biotech Genxi Biotechnology Group (referred to as "Genxi Bio") is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies.
Utilizing its pioneering FasTCAR and TruUCAR technology platforms, Genxi Bio is developing a number of autologous and allogeneic rich clinical-stage cancer treatment product pipelines.
These products are expected to overcome the major industry challenges that continue to exist in traditional CAR-T therapy, including long production time, poor production quality, high treatment costs, and lack of effective treatment for solid tumors.
To learn more about GracellBio, please visit www.
gracellbio.
com/Follow LinkedIn account @GracellBio.
Cautionary Statement Regarding Forward-Looking Statements The statements in this press release regarding future expectations, plans, prospects, and other non-historical facts may include those defined under the Private Securities Litigation Reform Act of 1995 "Forward-looking Statement".
These statements include, but are not limited to, statements related to the expected transaction and completion time of this issuance.
These statements may but not necessarily contain the following vocabulary and the corresponding negative or similar vocabulary: purpose, expectation, belief, estimation, prediction, prediction, plan, possibility, prospect, plan, potential, speculation, drafting, seeking, possible , Should, will.
Due to various important factors, actual results may differ materially from forward-looking statements, and there is no guarantee that any forward-looking statements will be realized.
These important factors include the factors mentioned in the "Risk Factors" section of the Form 20-F of Genxi Biotech’s recent annual report, as well as the potential risks, uncertainties and other important factors in the subsequent submission of Genxi Biologics to the US Securities Regulatory Commission.
Discussion of factors.
Any forward-looking statements in this statement only reflect current expectations, and Genxi Biotech is not responsible for publicly updating or reviewing any forward-looking statements, whether based on new information, future events or other reasons.
Readers are requested not to rely on forward-looking statements after the publication date of this press release.
[1]https://imf-d8-prod.
s3.
us-west-1.
wasabisys.
com/resource/patient-handbook.
pdf[2]Ludwig H, et al.
Oncologist.
2020 Sep;25(9) :e1406-e1413[3]Management of Newly Diagnosed Symptomatic Multiple Myeloma: updated Mayo Stratification of Myeloma and Risk-Adapted Therapy (mSMART) Consensus Guidelines
