Wyze Biotech's Universal CD19-CAR-DNT Cell Therapy for Autoimmune Diseases Receives IND Approval from CDE

Sep 28, 2023 10:12 CST Updated 10:12

Wyze Biotech

Innovative Immune Cell Therapy Developer

On September 26, 2023, Guangdong Ruishun Biotech Co., Ltd. ("Ruishun Biotech", Wyze Biotech. Co., Ltd.) announced that the IND application for "RJMty19 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases" submitted by its wholly-owned subsidiary, Zhejiang Ruijiamei Biotechnology Co., Ltd., has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2300661).

Autoimmune Diseases (AutoimmuneDisease, AID), commonly abbreviated as "autoimmune," refers to diseases caused by immune reactions to self-antigens, leading to damage of one's own tissues. AID can affect multiple organ systems in the human body, including the skin, joints, kidneys, and central nervous system, causing significant harm to human health and seriously affecting patients' quality of life and life expectancy. The overall incidence rate of AID is about 5-9% of the global population, with approximately 5%-8% in the United States and about 2-3% in China.

In recent years, B-cell depletion therapy has been widely used in the treatment of autoimmune diseases. Clinical studies both in and outside China have reported that autologous CAR-T cells (chimeric antigen receptor T cells) targeting CD19 can specifically bind to the CD19 antigen on the surface of B cells, eliminating B cells through antibody-dependent or complement-dependent cytotoxicity. This subsequently reduces the levels of inflammatory mediators in the body, exerts specific immunosuppressive therapeutic effects, and effectively treats autoimmune diseases such as systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).

To address the shortcomings of autologous CD19-CAR-T cell therapy products, such as long preparation cycles, high costs, and inability to be used immediately, Zhejiang Ruishun Biotech Co., Ltd. has developed the off-the-shelf universal RJMty19 injection. The product has demonstrated excellent safety and preliminary efficacy data in investigator-initiated clinical studies for the treatment of r/r B-NHL, and its clinical efficacy in treating AID is highly anticipated.

The IND application for the AID indication of RJMty19 Injection has been accepted by the CDE.This means that RJMty19 injection, as the world's first off-the-shelf universal CD19-CAR-DNT immune cell therapy product, has taken another step closer to formal registration clinical trials.

About RJMty19 Injection

RJMty19 Injection (main active ingredient: CD19-CAR-DNT cells), developed by Zhejiang Ruishun Biotech Co., Ltd. based on a global patent for humanized CD19-CAR, is an innovative universal off-the-shelf DNT cell therapy product. Compared with the six currently marketed CD19-CAR-T cell therapy products, CD19-CAR-DNT cells offer numerous advantages, such as standardized preparation, low production costs, and immediate availability for patients. It holds immense potential in the future market and can overcome the commercialization bottleneck of current autologous CAR-T cell products.

About Zhejiang Ruishun Biotech Co., Ltd.

Zhejiang Ruishun Biotech Co., Ltd. envisions "caring for life and benefiting humanity" and is on a mission to "develop innovative cellular medicines affordable for the general public." The company focuses on developing off-the-shelf, universal immune cell products centered around the DNT cell technology platform. As a pioneer of DNT cell immunotherapy globally, it has developed multiple off-the-shelf, universal cell therapy products based on the DNT cell technology platform, including RC1012 Injection and RJMty19 Injection. Currently, the company is conducting two registered IND clinical trials and two investigator-initiated clinical trials targeting hematological malignancies.

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