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Recent popular reports of Yimaike Science and technological progress are the best weapons to deal with the new crown infectious diseaseYimaike New Observation January 13, 2022 / Yimaike News eMedClub News/--Sibiman Biotechnology (Part 2) "CBMG" or the "Company"), a biopharmaceutical company focused on developing innovative cell therapies for the treatment of cancer and degenerative diseases, announced on January 11, 2022 that the U.
S.
Food and Drug Administration (FDA) awarded the Company Cellular Therapeutic product C-CAR039 (a novel autologous bispecific CAR-T therapy targeting CD19 and CD20 antigens) regenerative medicine advanced therapy (RMAT) qualification and fast track (FT) qualification for the treatment of relapsed or refractory and diffuse large B-cell lymphoma (r/r DLBCL)
.
Tony (Bizuo) Liu, Chairman and CEO of CBMG, said: "Today's FDA granting of C-CAR039 Regenerative Medicine Advanced Therapy (RMAT) designation and (FT) Fast Track designation is a great addition to C-CAR039 for CBMG.
Another exciting news after the IND approval! The designation is based on the product's ability to effectively improve objective and complete response rates in the treatment of relapsed or refractory and diffuse large B-cell lymphoma (r/r DLBCL).
Potential
.
The data obtained by the company's clinical trials in China also once again proved that C-CAR039 has the potential to become the current best therapy for patients with this indication
.
CBMG will start the Phase 1b/2 clinical trial of C-CAR039 in the United States as soon as possible
.
We will cooperate with The FDA is working closely to get the drug to patients in the U.
S.
and EU as early as possible through the best route
.
"About C-CAR039C-CAR039 is a novel second-generation 4-1BB dual-target CAR-T with an in-house developed, patent-protected and optimized bispecific antigen-binding domain that can simultaneously act on both CD19 and CD20 C-CAR039 can effectively clear CD19/CD20 single-positive or double-positive tumor cells in vivo and in vitro
.
Early clinical results of an investigator-initiated clinical study (IIT) currently underway in China have demonstrated that C-CAR039 is effective in relapsed or refractory patients.
Encouraging efficacy and favorable safety profile in B-cell non-Hodgkin lymphoma trials
.
As of April 20, 2021, 34 patients have received C-CAR039 infusions
.
Of these, 28 patients have received For safety assessment, efficacy was assessed in 27 patients
.
The median age of the patients was 55.
5 years, the median number of previous lines of therapy was 3, and 75% of the patients were An Arbor stage III/IV, 5 patients Patients (17.
9%) received bridging therapy
.
Cytokine release syndrome (CRS) occurred in 92% (26/28) of patients, and of these 26 patients, 25 patients had grade 1 or 2 CRS, and only 1 Grade 3 CRS occurred in 2 patients
.
Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2 patients, and no grade ≥ 2 ICANS occurred
.
The overall response rate (ORR) was 92.
6%, including complete response (CR) The median time to response was 1.
0 months
.
After a median follow-up of 7 months, 74.
1% of patients remained in CR .
The 6-month progression-free survival rate was 83.
2% (95% confidence interval, 69.
1-100.
0 ) . Sibeman will continue to follow up and evaluate patients long-term
.
(NCT04317885, NCT04655677, NCT04696432, NCT04693676) In addition, in June 2021, C-CAR039 has been granted Orphan Drug Designation (ODD) by the U.
S.
Food and Drug Administration (FDA) for the treatment of follicular lymphoma, a Indolent form of non-Hodgkin lymphoma
.
On December 10 of the same year, the FDA officially approved the IND application for C-CAR039
.
About Sibiman Biotechnology Sibiman Biosciences has been developing proprietary cell therapies for the treatment of cancer and degenerative diseases
.
To enhance global R&D capabilities and support the clinical development of multicellular therapy platform technologies, the company operates a state-of-the-art R&D center with five GMP product lines in Rockville, Maryland
.
In China, the company operates a GMP facility consisting of 12 independent cell production lines, which are designed and managed in compliance with Chinese and US GMP standards
.
The company's cell therapy technology platform covers both hematological tumors, solid tumors and stem cell therapies: the company's research in CAR-T treatment of blood cancers, including the potential best-in-class C-CAR039 (treatment of relapsed or refractory B cell non-Hodge) Novel CD19/CD20 dual-target CAR-T cell product for gold lymphoma (r/r B-cell NHL) and C-CAR088 (B-cell maturation antigen (BCMA) for multiple myeloma) using the latest digital production system specific CAR-T products); the company's solid tumor therapy cell therapy platform, including T-cell receptor therapy (TCRT) and tumor-infiltrating lymphocyte (TIL) technologies, will be launched in China and the United States simultaneously in 2022 targeting solid tumors Clinical study of TIL therapy
.
In terms of stem cell therapy, the Phase II Chinese clinical trial of AlloJoin-allogeneic adipose-derived mesenchymal stem cells (haMPC) for the treatment of KOA has been completed and a registrational Phase III clinical trial will be launched in early 2022, Re-join human autologous adipose-derived mesenchymal stem cells Phase II clinical trials of progenitor cells for the treatment of knee osteoarthritis (KOA) are also underway
.
S.
Food and Drug Administration (FDA) awarded the Company Cellular Therapeutic product C-CAR039 (a novel autologous bispecific CAR-T therapy targeting CD19 and CD20 antigens) regenerative medicine advanced therapy (RMAT) qualification and fast track (FT) qualification for the treatment of relapsed or refractory and diffuse large B-cell lymphoma (r/r DLBCL)
.
Tony (Bizuo) Liu, Chairman and CEO of CBMG, said: "Today's FDA granting of C-CAR039 Regenerative Medicine Advanced Therapy (RMAT) designation and (FT) Fast Track designation is a great addition to C-CAR039 for CBMG.
Another exciting news after the IND approval! The designation is based on the product's ability to effectively improve objective and complete response rates in the treatment of relapsed or refractory and diffuse large B-cell lymphoma (r/r DLBCL).
Potential
.
The data obtained by the company's clinical trials in China also once again proved that C-CAR039 has the potential to become the current best therapy for patients with this indication
.
CBMG will start the Phase 1b/2 clinical trial of C-CAR039 in the United States as soon as possible
.
We will cooperate with The FDA is working closely to get the drug to patients in the U.
S.
and EU as early as possible through the best route
.
"About C-CAR039C-CAR039 is a novel second-generation 4-1BB dual-target CAR-T with an in-house developed, patent-protected and optimized bispecific antigen-binding domain that can simultaneously act on both CD19 and CD20 C-CAR039 can effectively clear CD19/CD20 single-positive or double-positive tumor cells in vivo and in vitro
.
Early clinical results of an investigator-initiated clinical study (IIT) currently underway in China have demonstrated that C-CAR039 is effective in relapsed or refractory patients.
Encouraging efficacy and favorable safety profile in B-cell non-Hodgkin lymphoma trials
.
As of April 20, 2021, 34 patients have received C-CAR039 infusions
.
Of these, 28 patients have received For safety assessment, efficacy was assessed in 27 patients
.
The median age of the patients was 55.
5 years, the median number of previous lines of therapy was 3, and 75% of the patients were An Arbor stage III/IV, 5 patients Patients (17.
9%) received bridging therapy
.
Cytokine release syndrome (CRS) occurred in 92% (26/28) of patients, and of these 26 patients, 25 patients had grade 1 or 2 CRS, and only 1 Grade 3 CRS occurred in 2 patients
.
Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2 patients, and no grade ≥ 2 ICANS occurred
.
The overall response rate (ORR) was 92.
6%, including complete response (CR) The median time to response was 1.
0 months
.
After a median follow-up of 7 months, 74.
1% of patients remained in CR .
The 6-month progression-free survival rate was 83.
2% (95% confidence interval, 69.
1-100.
0 ) . Sibeman will continue to follow up and evaluate patients long-term
.
(NCT04317885, NCT04655677, NCT04696432, NCT04693676) In addition, in June 2021, C-CAR039 has been granted Orphan Drug Designation (ODD) by the U.
S.
Food and Drug Administration (FDA) for the treatment of follicular lymphoma, a Indolent form of non-Hodgkin lymphoma
.
On December 10 of the same year, the FDA officially approved the IND application for C-CAR039
.
About Sibiman Biotechnology Sibiman Biosciences has been developing proprietary cell therapies for the treatment of cancer and degenerative diseases
.
To enhance global R&D capabilities and support the clinical development of multicellular therapy platform technologies, the company operates a state-of-the-art R&D center with five GMP product lines in Rockville, Maryland
.
In China, the company operates a GMP facility consisting of 12 independent cell production lines, which are designed and managed in compliance with Chinese and US GMP standards
.
The company's cell therapy technology platform covers both hematological tumors, solid tumors and stem cell therapies: the company's research in CAR-T treatment of blood cancers, including the potential best-in-class C-CAR039 (treatment of relapsed or refractory B cell non-Hodge) Novel CD19/CD20 dual-target CAR-T cell product for gold lymphoma (r/r B-cell NHL) and C-CAR088 (B-cell maturation antigen (BCMA) for multiple myeloma) using the latest digital production system specific CAR-T products); the company's solid tumor therapy cell therapy platform, including T-cell receptor therapy (TCRT) and tumor-infiltrating lymphocyte (TIL) technologies, will be launched in China and the United States simultaneously in 2022 targeting solid tumors Clinical study of TIL therapy
.
In terms of stem cell therapy, the Phase II Chinese clinical trial of AlloJoin-allogeneic adipose-derived mesenchymal stem cells (haMPC) for the treatment of KOA has been completed and a registrational Phase III clinical trial will be launched in early 2022, Re-join human autologous adipose-derived mesenchymal stem cells Phase II clinical trials of progenitor cells for the treatment of knee osteoarthritis (KOA) are also underway
.
