Rui Therapeutics Submits IPO Prospectus Highlighting Promising Clinical Results of Allogeneic CD19 CAR-NK Therapy KN5501 in Refractory Systemic Lupus Erythematosus

Rui Therapeutics, as a globally leading off-the-shelf universal cell therapy pharmaceutical company, was invited by the American College of Rheumatology (ACR) to deliver a keynote speech at the 2024 Annual Meeting. Dr. Qian Hao, CEO of the company, presented on behalf of the company, reporting on “Allogenic CD19 CAR NK Cell Therapy to Relapse and Refractory Systemic Lupus Erythematosus"The latest clinical research results."

The 2024 Annual Meeting of the American College of Rheumatology will be held from November 14 to 19 in Washington, D.C., USA. It is an internationally prestigious event in the field of rheumatology that has gained significant attention. This conference will bring together top rheumatology experts from around the world to discuss the latest cutting-edge research achievements in the field of rheumatology.

This study has completed the enrollment and treatment of 22 subjects, including 9 subjects with systemic lupus erythematosus (SLE) having severe renal organ system involvement (assessed as BILAG A), and 6 subjects with severe hematological system involvement who were refractory to multiple immunosuppressants and biologics. According to SRI, LLDAS, and Doris (2021) remission criteria, among the 8 subjects followed up for over 9 months, the SRI-4 response rate was 100%, SRI-6 response rate was 100%, LLDAS response rate was 75.0%, and Doris remission rate was 50%. The longest follow-up time for subjects achieving Doris remission exceeded 14 months, maintaining remission without relapse. All subjects showed significant and sustained improvement in SLEDAI and PGA scores, with no relapses reported.

After receiving KN5501 treatment, the B cells regenerated in subjects were mainly Naive B cells, with a significant reduction in Memory B cells. Despite the recovery of B cells, the subjects maintained durable clinical benefits without new disease activity. Safety data showed that only 2 out of 22 subjects reported grade 1 cytokine release syndrome (CRS) related to KN5501, which resolved within one day after anti-cytokine therapy. No neurotoxicity (ICANS), other treatment-related adverse events (AEs), or dose-limiting toxicity (DLT) was observed. Moreover, no infections were reported in any subject during the follow-up period of over one year.

The results of the KN5501 clinical study presented at this year's ACR annual meeting show that KN5501 CD19 CAR-NK has significant efficacy and excellent safety in subjects with moderate to severe active relapsing/refractory SLE, providing new hope for the treatment of systemic lupus erythematosus.