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Cullinan Therapeutics Reports Promising Autoimmune Treatment Results

Cullinan Therapeutics said new clinical data from its autoimmune portfolio showed signs of remission and organ response across its CD19 and BCMA T-cell engager programs.

For CLN-978, the company reported new multi-dose data from its Phase 1 OUrACE rheumatoid arthritis study in two heavily pretreated, poly-refractory patients. One patient with rheumatoid arthritis who had been refractory to immediate prior rituximab reached DAS28-ESR remission, with the baseline disease score falling from 4.0 to 2.2 by week 4 and remaining there through week 8. The company said the remission was accompanied by a rapid reduction in rheumatoid arthritis-associated autoantibodies.

In the OUrACE lupus study, safety data from the first three systemic lupus erythematosus patients treated with a multi-dose regimen were said to match the favorable safety profile seen in the earlier rheumatoid arthritis cohort. Cullinan also said clinical observations in lupus patients with nephritis included rapid improvement in proteinuria, and it expects a Phase 2a expansion in lupus nephritis to begin in early 2027.

For velinotamig, the company said the first two refractory lupus patients who completed four intravenous doses both showed rapid and marked reductions in SLEDAI-2K scores and proteinuria, and both achieved complete renal response. Their baseline SLEDAI-2K scores were 16 and 14, and by week 8 they had fallen to 0 and 2. Cullinan said the clinical improvements tracked with pharmacodynamic changes consistent with the drug’s mechanism.

The company also said velinotamig showed no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome in those two patients.

Cullinan said it plans to report additional CLN-978 multi-dose data in rheumatoid arthritis in the third quarter of 2026 and in lupus in the fourth quarter, with more velinotamig data expected before year-end. It also plans to start a Phase 1/2a trial in autoimmune cytopenias in the first quarter of 2027. As a result of these announcements, the company's shares have moved 3.15% on the market, and are now trading at a price of $13.595. Check out the company's full 8-K submission here.

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