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of Medical Microphone! ★ Dr.
Wenling Li, a senior expert in the clinical field, appoints ★ Dr.
Suhua Zhang, a senior executive in the biopharmaceutical industry, as chief commercial officerOctober 18, 2022/eMedClub News/-- Suzhou, Jiangsu, China, Shanghai and San Diego, Calif.
(October 17, 2022) -- Ganxi Biotechnology Group (NASDAQ: GRCL; Ganxi Biologics recently announced that a Phase 1/2 registrational clinical trial in China to comprehensively evaluate the efficacy of GC007g in the treatment of relapsed/refractory acute B-lymphoblastic 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
.
"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.
”
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-lymphocytic 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 figure is about 7,40 0[2] (latest published data in 2020).
Among adult patients, B-ALL patients account for about 75%
of all ALL patients.
About Vanxi Biotech Group ("Biotech") is a global clinical-stage biopharmaceutical company
dedicated to the discovery and development of breakthrough cell therapies.
Leveraging its groundbreaking FasTCAR and TruUCAR breakthrough technology platforms and the SMART CARTM technology module, Ganxi Biotech is developing a rich pipeline of autologous and allogeneic clinical-stage cancer treatment products
.
These products are expected to overcome the major industry challenges that continue to exist with traditional CAR-T therapies, including long production times, poor cell quality, high treatment costs, and lack of effective treatment for solid tumors
.
To learn more about Genxi Biologics, please visit the www.
gracellbio.
com/ Follow LinkedIn account @GracellBio
.
Cautionary Statement Regarding Forward-Looking Statements Statements in this press release regarding future expectations, plans, prospects and other non-historical facts may contain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995 。 These statements may, but do not necessarily contain, the following words and corresponding negative forms or similar words: purpose, anticipate, believe, estimate, anticipate, predict, intend, may, prospect, plan, potential, speculate, propose, seek, may, should, will
.
Actual results may differ materially from the forward-looking statements due to various important factors, and there can be no assurance that any forward-looking statements will materialize
.
These important factors include those mentioned in the "Risk Factors" section of the annual report Form 20-F and the discussion
of potential risks, uncertainties and other important factors in the subsequent post-period filings of the SEC.
Any forward-looking statements in this statement reflect current expectations only and we undertake no obligation to publicly update or review any forward-looking statements, whether based on new information, future events or otherwise
.
Readers are cautioned not to rely on forward-looking statements
after the date of this press release.
[1].
Data source: American Cancer Society ↑[2].
Data source: Clarivate | DRG: Acute Lymphoblastic Leukemia - Epidemiology ↑
of Medical Microphone! ★ Dr.
Wenling Li, a senior expert in the clinical field, appoints ★ Dr.
Suhua Zhang, a senior executive in the biopharmaceutical industry, as chief commercial officerOctober 18, 2022/eMedClub News/-- Suzhou, Jiangsu, China, Shanghai and San Diego, Calif.
(October 17, 2022) -- Ganxi Biotechnology Group (NASDAQ: GRCL; Ganxi Biologics recently announced that a Phase 1/2 registrational clinical trial in China to comprehensively evaluate the efficacy of GC007g in the treatment of relapsed/refractory acute B-lymphoblastic 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 preparedusing 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-lymphocytic 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 figure is about 7,40 0[2] (latest published data in 2020).
Among adult patients, B-ALL patients account for about 75%
of all ALL patients.
About Vanxi Biotech Group ("Biotech") is a global clinical-stage biopharmaceutical company
dedicated to the discovery and development of breakthrough cell therapies.
Leveraging its groundbreaking FasTCAR and TruUCAR breakthrough technology platforms and the SMART CARTM technology module, Ganxi Biotech is developing a rich pipeline of autologous and allogeneic clinical-stage cancer treatment products
.
These products are expected to overcome the major industry challenges that continue to exist with traditional CAR-T therapies, including long production times, poor cell quality, high treatment costs, and lack of effective treatment for solid tumors
.
To learn more about Genxi Biologics, please visit the www.
gracellbio.
com/ Follow LinkedIn account @GracellBio
.
Cautionary Statement Regarding Forward-Looking Statements Statements in this press release regarding future expectations, plans, prospects and other non-historical facts may contain "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995 。 These statements may, but do not necessarily contain, the following words and corresponding negative forms or similar words: purpose, anticipate, believe, estimate, anticipate, predict, intend, may, prospect, plan, potential, speculate, propose, seek, may, should, will
.
Actual results may differ materially from the forward-looking statements due to various important factors, and there can be no assurance that any forward-looking statements will materialize
.
These important factors include those mentioned in the "Risk Factors" section of the annual report Form 20-F and the discussion
of potential risks, uncertainties and other important factors in the subsequent post-period filings of the SEC.
Any forward-looking statements in this statement reflect current expectations only and we undertake no obligation to publicly update or review any forward-looking statements, whether based on new information, future events or otherwise
.
Readers are cautioned not to rely on forward-looking statements
after the date of this press release.
[1].
Data source: American Cancer Society ↑[2].
Data source: Clarivate | DRG: Acute Lymphoblastic Leukemia - Epidemiology ↑
