Preliminary Data on Relma-Cel Injection in Adults with Lupus in China at Eular 2024

SHANGHAI, May 30, 2024 — JW (Cayman) Therapeutics Co. Ltd ("JW Therapeutics") has announced promising preliminary clinical data for its innovative cell therapy, relmacabtagene autoleucel ("relma-cel"), in adults with active systemic lupus erythematosus (SLE) in China. These findings were presented at the 2024 European Alliance of Associations for Rheumatology Congress (EULAR 2024).

Study Background and Design

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder causing extensive inflammation and tissue damage across various organs. China has the highest number of SLE patients globally, with around one million individuals affected. Current standard treatments, including corticosteroids and immunosuppressants, often result in poor tolerance and long-term efficacy, especially in patients with severe SLE.

The study, a single-arm, open-label, multi-center dose escalation trial (NCT05765006), aimed to evaluate the safety and efficacy of relma-cel in SLE patients. Participants received intravenous infusions of CAR-T cells at dosages ranging from 25×10^6 (25M) to 100×10^6 (100M).

Promising Results from Initial Data

As of April 8, 2024, twelve patients had received a single infusion of relma-cel, with safety and efficacy assessments conducted across different dosage groups. Data from the low-dose group, with a follow-up period extending to December 18, 2023, were presented at EULAR 2024.

Three female patients with active SLE and multi-organ involvement, previously treated with high-dose steroids and immunosuppressants, received a 25M dosage of relma-cel and completed at least a four-month follow-up. These individuals exhibited significant improvements in clinical signs and symptoms post-treatment. The Systemic Lupus Erythematosus Disease Activity Index (SRI-4) scores drastically reduced from 8-14 to 0/1, with all achieving SRI-4 responses and two attaining lupus low disease activity status (LLDAS). Notably, these patients discontinued the use of corticosteroids and immunosuppressants.

Safety and Pharmacokinetics

The relma-cel therapy demonstrated a manageable safety profile. Two patients experienced cytokine release syndrome (CRS) (one Grade 1 and one Grade 3), with no reported neurotoxicity. Other side effects included cytopenia, infection, macrophage activation syndrome (MAS), and effusion, all of which resolved by Day 60 with appropriate treatment.

Broader Impact and Future Directions

The preliminary data also included results from nine patients across different dose levels (25M, 50M, and 75M). All patients achieved an SRI-4 response three months post-infusion, with those followed for at least six months maintaining a 100% SRI-4 response rate. Furthermore, 91.67% of patients ceased traditional corticosteroids and immunosuppressants, reducing medication burden and potential side effects. Significant improvements were observed in organ damage, SLE disease activity, anti-double-stranded DNA (dsDNA) antibody levels, and 24-hour urinary protein levels.

Relma-cel achieved rapid and complete depletion of peripheral B cells, with a median onset time of four days. CAR-T cells expanded quickly, peaking around Day 8, with a clear dose-response relationship observed.

Encouraging Prospects

The relma-cel therapy has shown deep and durable remissions in moderate to severe SLE patients, maintaining a favorable safety profile. This study, the largest of its kind for CAR-T therapy in SLE, provides robust efficacy and safety data, paving the way for relma-cel's swift progression to a Biologics License Application (BLA).

Dr. Mark J. Gilbert, Chief Medical Officer of JW Therapeutics, highlighted the potential of relma-cel to achieve low disease activity or drug-free remission in SLE patients, positioning it as a promising treatment option.

About JW Therapeutics

Founded in 2016, JW Therapeutics is dedicated to developing, manufacturing, and commercializing cell immunotherapy products. The company aims to lead innovation in cell immunotherapy, providing breakthrough treatments for hematologic malignancies, solid tumors, and autoimmune diseases. Relma-cel, their flagship product, has already been approved in China for treating certain types of lymphoma and holds significant promise for SLE treatment.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!