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Recent popular reports from Yimike ★ Genxi Bio will announce the pre-clinical results of CD19/CD7 dual-targeting allogeneic CAR-T candidate product GC502 in ASH2021★ Dr.
Sersch, Chief Medical Officer of Genxi Bio: Innovation never stops, just for Unlocking the shackles of lifeFengke Transcend November 20, 2021/eMedClub News/--Genxi Biotechnology Group (NASDAQ: GRCL; referred to as "Genxi Bio"), a company dedicated to development A global clinical-stage biopharmaceutical company that uses efficient and economical cell therapy for cancer treatment today announced that the U.
S.
Food and Drug Administration (FDA) has granted it the orphan of the BCMA/CD19 dual-target CAR-T cell therapy developed based on the FasTCAR technology platform Drug qualification (ODD) for the treatment of multiple myeloma
.
"GC012F is a leading candidate product developed based on Genxi Biotech's FasTCAR technology platform, which can achieve'complete production next day'.
Its unique design gives it the advantage of simultaneously targeting BCMA and CD19 two major tumor targets
.
" Genxi Biologics Chief Medical Officer Dr.
Martina Sersch said: “In a phase I clinical trial initiated by investigators in China, GC012F has shown rapid, in-depth and long-lasting treatment effects for patients with relapsed/refractory multiple myeloma, and most The enrolled patients belong to the “high-risk patients” defined by the mSMART 3.
0 standard and are generally extremely difficult to treat
.
We are very pleased that GC012F has been granted orphan drug designation by the US FDA, which marks a solid step forward in the globalization of our clinical programs step
.
Next, we will continue to be of clinical value-oriented and meet the field of multiple myeloma is not entirely the need to provide patients with deep and long-lasting effect, and help them to better prolong life
.
"During the ASCO annual meeting and EHA conference in June this year, Genxi Bio announced the long-term follow-up data of GC012F
.
Currently, this candidate product is undergoing a number of multi-center, phase I clinical trials initiated by researchers in China, including for multiple Clinical trials for new patients with myeloma
.
In the United States, the company is also steadily advancing the technology transfer with Lonza Group (Lonza) to provide production capacity guarantee for GC012F
.
The
company plans to submit a new drug clinical trial to the U.
S.
FDA in the first half of 2022 .
Trial application
.
The
certification of orphan drug qualification originated from the "Orphan Drug Act" (ODA) and was granted by the US Food and Drug Administration.
More safe and effective innovative drugs
.
In return, applicants that have been awarded orphan drug qualifications will be eligible for a series of specific drug development incentive policies, including: after the approval of the regulatory authorities, they can enjoy the market for up to 7 years franchise tax credits related to clinical trials, as well as relief prescription drug user fees and other
.
About multiple myeloma multiple myeloma is the most common in the United States the third largest hematologic malignancies, tumor cells derived from bone marrow plasma cells, A type of immune cell responsible for secreting anti-infective antibodies
.
Approximately 160,000 patients are diagnosed with multiple myeloma each year in the world; in 2020, the United States is expected to have more than 32,000 confirmed patients
.
In recent years, although the treatment of multiple myeloma has been Much progress has been made, but the clinical treatment effect is still not satisfactory, and no cure has been achieved yet
.
Standards such as the International Myeloma Working Group (IMWG) and Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines will have specific cytogenetic abnormalities or other Abnormal multiple myeloma patients are classified as high-risk patients.
This part of the population accounts for 20-30% of all multiple myeloma patients
.
High-risk patients have a high risk of early recurrence, progression-free survival, and short overall survival.
Patients with multiple myeloma are considered 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 researchers to evaluate 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 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
.
Sersch, Chief Medical Officer of Genxi Bio: Innovation never stops, just for Unlocking the shackles of lifeFengke Transcend November 20, 2021/eMedClub News/--Genxi Biotechnology Group (NASDAQ: GRCL; referred to as "Genxi Bio"), a company dedicated to development A global clinical-stage biopharmaceutical company that uses efficient and economical cell therapy for cancer treatment today announced that the U.
S.
Food and Drug Administration (FDA) has granted it the orphan of the BCMA/CD19 dual-target CAR-T cell therapy developed based on the FasTCAR technology platform Drug qualification (ODD) for the treatment of multiple myeloma
.
"GC012F is a leading candidate product developed based on Genxi Biotech's FasTCAR technology platform, which can achieve'complete production next day'.
Its unique design gives it the advantage of simultaneously targeting BCMA and CD19 two major tumor targets
.
" Genxi Biologics Chief Medical Officer Dr.
Martina Sersch said: “In a phase I clinical trial initiated by investigators in China, GC012F has shown rapid, in-depth and long-lasting treatment effects for patients with relapsed/refractory multiple myeloma, and most The enrolled patients belong to the “high-risk patients” defined by the mSMART 3.
0 standard and are generally extremely difficult to treat
.
We are very pleased that GC012F has been granted orphan drug designation by the US FDA, which marks a solid step forward in the globalization of our clinical programs step
.
Next, we will continue to be of clinical value-oriented and meet the field of multiple myeloma is not entirely the need to provide patients with deep and long-lasting effect, and help them to better prolong life
.
"During the ASCO annual meeting and EHA conference in June this year, Genxi Bio announced the long-term follow-up data of GC012F
.
Currently, this candidate product is undergoing a number of multi-center, phase I clinical trials initiated by researchers in China, including for multiple Clinical trials for new patients with myeloma
.
In the United States, the company is also steadily advancing the technology transfer with Lonza Group (Lonza) to provide production capacity guarantee for GC012F
.
The
company plans to submit a new drug clinical trial to the U.
S.
FDA in the first half of 2022 .
Trial application
.
The
certification of orphan drug qualification originated from the "Orphan Drug Act" (ODA) and was granted by the US Food and Drug Administration.
More safe and effective innovative drugs
.
In return, applicants that have been awarded orphan drug qualifications will be eligible for a series of specific drug development incentive policies, including: after the approval of the regulatory authorities, they can enjoy the market for up to 7 years franchise tax credits related to clinical trials, as well as relief prescription drug user fees and other
.
About multiple myeloma multiple myeloma is the most common in the United States the third largest hematologic malignancies, tumor cells derived from bone marrow plasma cells, A type of immune cell responsible for secreting anti-infective antibodies
.
Approximately 160,000 patients are diagnosed with multiple myeloma each year in the world; in 2020, the United States is expected to have more than 32,000 confirmed patients
.
In recent years, although the treatment of multiple myeloma has been Much progress has been made, but the clinical treatment effect is still not satisfactory, and no cure has been achieved yet
.
Standards such as the International Myeloma Working Group (IMWG) and Mayo Stratification for Myeloma and Risk-Adapted Therapy (mSMART) consensus guidelines will have specific cytogenetic abnormalities or other Abnormal multiple myeloma patients are classified as high-risk patients.
This part of the population accounts for 20-30% of all multiple myeloma patients
.
High-risk patients have a high risk of early recurrence, progression-free survival, and short overall survival.
Patients with multiple myeloma are considered 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 researchers to evaluate 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 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
.
