At the 64th ASH Annual Meeting, we will present the clinical data of FasTCAR-T GC012F for the first time in patients with multiple myeloma

Global clinical-stage biopharmaceutical company Ganxi Biotechnology Group (NASDAQ: GRCL; On November 3, "Ganxi Biologics") announced the preliminary data of a Phase 1 clinical trial initiated by its investigators in China to evaluate the efficacy
of its candidate GC012F based on the FasTCAR platform in the treatment of high-risk patients with multiple myeloma (NDMM) who are eligible for transplantation.
Details of the data will be presented orally at the 64th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana, USA, on December 10, 2022, at 5:15 p.
m.
Central Time.

GC012F is a dual-target autologous CAR-T candidate that can simultaneously target both B cell maturation antigen (BCMA) and CD19 therapeutic targets
.
The product candidate relies on the company's proprietary FasTCAR platform and has the advantage
of "next-day production".

As of the deadline for summary data on July 25, 2022, 13 newly diagnosed multiple myeloma patients eligible for transplantation have received GC012F
.
All patients have one or more high-risk features
.
After chemotherapy pretreatment with cyclophosphamide and fludarabine, enrolled patients received a single infusion of GC012F at three different dose levels: 1x105 cells/kg body weight (dose group 1), 2x105 cells/kg body weight (dose group 2), and 3x105 cells/kg body weight (dose group 3).

This clinical trial is ongoing
.
As of ASH abstract data cut-off, the median follow-up of 13 patients with evaluable efficacy was 5.
3 months (range: 2.
3 to 12.
5 months):

● Overall response rate up to 100%

● 69% of patients achieved a strictly complete response (sCR); Currently, the study is still continuing to follow patients to assess the deepening response

● All patients were MRD negative

● At the first and sixth months, the phased test evaluation of MRD was performed by EuroFlow method, and all evaluable patients achieved MRD negative at both time points

● Strong expansion of CAR-T cells was observed in all patients

Moreover, clinical data have preliminarily shown excellent safety:

● Only 23% (3/13) of patients develop grade 1-2 cytokine release syndrome (CRS)

● No CRS of grade 3 or higher and no level of immune effector cell-associated neurotoxic syndrome (ICANS) has been observed

Details of the oral presentation are as follows:

● Abstract: BCMA/CD19 dual-target FasTCAR-T cell therapy (GC012F) is a Phase 1, open-label, single-arm clinical study as a first-line therapy for high-risk primary patients with multiple myeloma who meet the conditions for transplantation

       Abstract title: Phase I Open-Label Single-Arm Study of BCMA/CD19 Dual-Targeting FasTCAR-T Cells (GC012F) As First-Line Therapy for Transplant-Eligible Newly Diagnosed High-Risk Multiple Myeloma

● Summary number: 162295

       Abstract ID: 162295

● Session name: 704.
Cellular immunotherapy: early and exploratory therapies: CAR-T therapy for multiple myeloma and T cell therapy after allogeneic stem cell transplantation

       Session Name: 704.
Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT

● Session time: Saturday, December 10, 2022, 4:00-5:30 p.
m.
Central Time

       Session Date: Saturday, Dec.
10, 2022 from 4-5:30 p.
m.
CT

● Reporting time: 5:15 p.
m.
Central Time

       Presentation Time: 5:15 p.
m.
CT

● Location: Ernest N.
Morial Convention Center, Great Hall A/D

       Location: Ernest N.
Morial Convention Center, Great Hall A/D

A detailed summary has been published
on the ASH website.

"The annual ASH Annual Meeting brings together the world's top minds in hematology and oncology
.
We are very pleased to take this event to release the clinical data
of GC012F as a first-line drug treatment for patients with new diagnosis of multiple myeloma for the first time.
FasTCAR-T GC012F targeting the BCMA/CD19 dual target has demonstrated excellent safety and encouraging efficacy
in the treatment of newly diagnosed patients.
Dr.
Wenling Li, Chief Medical Officer of Ganxi Biologics, said, "We believe that the data released this time can further verify the clinical application potential of our proprietary FasTCAR next-day production platform for different indications and demonstrate the broad prospects
of GC012F in the treatment of multiple myeloma.
" Exploring the clinical benefits of newly diagnosed patients will become a new frontier in CAR-T therapy research, and Genxi Biologics will continue to be committed to bringing disruptive innovation
to patients.
"

About GC012F

GC012F is a BCMA/CD19 dual-target CAR-T therapy candidate developed based on the FasTCAR platform, which is currently being evaluated in investigator-initiated clinical trials in China for the treatment of multiple myeloma and B-cell non-Hodgkin lymphoma
.
By targeting CD19 and BCMA targets simultaneously, GC012F is expected to bring rapid, in-depth and long-lasting therapeutic effects, helping patients with multiple myeloma and B-cell non-Hodgkin lymphoma to improve treatment response rate and reduce recurrence rate
.

About FasTCAR

Preclinical studies have shown that the CAR-T cell phenotype produced by FasTCAR, a proprietary platform of Wanxi Biotech, is younger and less depleted, and has enhanced
expansion ability, persistence, bone marrow migration ability and tumor cell clearance activity.
With the advantage of "next-day production", FasTCAR platform technology can greatly improve cell production efficiency, which is expected to significantly reduce production costs, shorten time to market, and enable cell therapy to benefit more cancer patients
.