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Global clinical-stage biopharmaceutical company Ganxi Biotechnology Group (NASDAQ: GRCL; "Ganxi Biologics") announced that the Phase 1/2 registration clinical trial in China to comprehensively evaluate the efficacy of GC007g in the treatment of relapsed/refractory acute B-cell leukemia (r/r B-ALL) has successfully entered the Phase 2 study stage, and the first enrolled patient has been dosed
.
GC007g is a donor-derived allogeneic CAR-T cell therapy targeting CD19 under Ganxi Biologics for the treatment of patients with B-ALL who have relapsed after allogeneic stem cell transplantation
.
This allogeneic cell therapy is prepared using T cells from healthy donors matched with human leukocyte antigen (HLA), providing an alternative to patients who are not eligible for autologous CAR-T therapy due to poor autologous T cell health, infection, or other reasons
.
In phase 1 clinical trials, GC007g has achieved encouraging data
on efficacy and safety.
The Company is continuing to conduct a registrational Phase 2 clinical trial in China to further evaluate the efficacy and safety
of GC007g in patients with r/r B-ALL at the recommended Phase 2 dose.
"Currently, patients with B-ALL who relapse after allogeneic stem cell transplantation often have a poor prognosis and there is a clear clinically unmet need
.
Donor-derived allogeneic CAR-T therapy is expected to bring new treatment options and hope to some patients who are not suitable for other treatments, including autologous CAR-T therapy," said Dr.
Wenling Li, Chief Medical Officer of Ganxi Biologics, "We believe that GC007g will be expected to become the first donor-derived allogeneic CAR-T therapy of its kind in China to benefit patients
.
" At the same time, GC007g is also the first product candidate to officially enter the registration clinical trial, which is a milestone for the rapid development of the company and encourages the team to continue to pursue
the innovation of cell therapy.
"
About GC007g
GC007g is a donor-derived allogeneic CAR-T cell therapy targeting CD19 that is prepared
using HLA-matched T cells from healthy donors.
Currently, the product candidate is undergoing a Phase 1/2 registrational clinical trial in China to evaluate its efficacy
in patients with B-ALL who have relapsed after allogeneic transplantation and are not eligible for autologous CAR-T therapy.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a hematological malignancy characterized by abnormal proliferation of immature lymphocytes in the bone marrow, usually including acute T-lymphoblastic leukemia (T-ALL) or acute B-lymphoblastic leukemia (B-ALL).
Approximately 64,000 patients worldwide are diagnosed with ALL each year; In 2022, approximately 6,660 [1] patients in the United States are expected to be diagnosed with ALL; In China, this number is about 7,400[2] (latest published data in 2020).
Among adult patients, B-ALL patients account for about 75%
of all ALL patients.
[1] data source: American Cancer Society
[2] data source: Clarivate | DRG: Acute Lymphoblastic Leukemia - Epidemiology
