The world's first clinical trial data for CAR-NK treatment of lupus in China, offering hope for a cure to lupus patients

For the treatment of relapsed and refractory systemic lupus erythematosus (SLE), Rui Therapeutics has developed the internationally leading new generation of "universal" and "off-the-shelf" CAR-NK cell therapy drug KN5501, utilizing a unique HTAS-RV™ delivery system and excellent NK cell expansion and cryopreservation formulation technology.

Currently, Rui Therapeutics is collaborating with the Rheumatology and Immunology Department of Shanghai Changhai Hospital to conduct a clinical trial study initiated by researchers on "CD19-targeted CAR-NK cell therapy for relapsed/refractory systemic lupus erythematosus." Four severe SLE patients have completed CAR-NK cell infusion treatment. According to the internationally accepted SLEDAI-2K (mild, moderate, severe) three-level disease scoring standard, all four severe patients achieved deep remission after this cell therapy, changing from "severe" to "mild," and showing corresponding durability. Among them, two severe patients achieved deep remission after 15 days of treatment, with the SLEDAI-2K disease score dropping from 14 and 17 (severe disease) to 1 and 3 (mild disease), respectively, demonstrating a very positive effect of CAR-NK cell therapy. This is the first international clinical report using CAR-NK to treat systemic lupus erythematosus.

The clinical trial is actively recruiting more patients, hoping to bring this highly potential cell therapy drug to the market as soon as possible, benefiting a wide range of systemic lupus erythematosus patients and bringing hope for a cure to this "incurable cancer."

About Rui Therapeutics

Rui Therapeutics, established in June 2021, is a platform company focusing on the research and development of new drugs based on the new generation of cells. The company was co-founded by returned overseas scientists and executives of multinational pharmaceutical companies, committed to innovation in core technologies with independent intellectual property rights. Rui Therapeutics has established three major platforms in the field of innovative drug therapy: (1) Universal CAR-NK cell therapy platform; (2) Therapeutic single-base gene editing platform; (3) Regenerative medicine platform induced by small molecules. The company focuses on inventive innovation, and each platform has established its own core technology with independent intellectual property rights, including CAR structure design technology for CAR-NK cell therapy, HTAS-RV™ viral delivery system, CAR-NK™ taming technology, and innovation in NK drug formulation.

Surrounding the three innovative drug technology platforms built, the company has laid out the most cutting-edge First-in-class related pipeline products, focusing on unmet clinical needs in autoimmune diseases, tumors, genetic diseases, etc.

About Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a typical systemic autoimmune disease, commonly known as "incurable cancer," and currently has no cure. Its pathogenesis mainly involves B cells producing excessive autoantibodies and forming immune complexes in the body, causing damage to multiple systems and organs throughout the body, including renal failure, central nervous system involvement, and hematopoietic system damage. Common typical symptoms include: facial butterfly rash, discoid rash, oral ulcers, hair loss; abdominal pain, pericarditis, cardiopulmonary damage, pleurisy, pleural effusion; thrombosis, vasculitis, leukopenia, thrombocytopenia, proteinuria, hematuria; polyarthralgia, arthritis, lupus nephritis, lupus encephalopathy.

There are about 1 million patients in China, with an annual increase of 80,000 to 100,000. The patient population ratio of males to females is 1:9; it mainly occurs in women of childbearing age between 18 and 40 years old, and can be life-threatening in severe cases. The current treatment for systemic lupus erythematosus mainly relieves symptoms through immune modulation, including corticosteroids, antimalarial drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), and cytotoxic immunosuppressants. However, these drugs cannot cure and have significant toxic side effects, such as the commonly used cyclophosphamide, which not only affects women's fertility but also has certain teratogenicity and carcinogenicity.