Cullinan Therapeutics Reports Promising Clinical Data

By Ahmed Jamerson • Wednesday, June 10 16:02 • Permanent Link

Cullinan Therapeutics said new clinical data from its autoimmune portfolio showed remissions, deep B-cell depletion and complete renal responses across early-stage studies of its CD19 and BCMA T-cell engagers.

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

In systemic lupus erythematosus, safety data from the first three patients treated with a multi-dose CLN-978 regimen were said to be consistent with the favorable safety profile previously seen in RA. Cullinan also said clinical observations in lupus nephritis patients, including rapid improvement in proteinuria, support a planned phase 2a expansion in lupus nephritis expected to begin in early 2027.

For velinotamig, the BCMA T-cell engager, Cullinan said the first two refractory SLE 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; by week 8, those scores were 0 and 2. The company said the clinical improvements tracked with pharmacodynamic changes consistent with the drug’s mechanism, and no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was observed in either patient.

Cullinan said it expects additional CLN-978 multi-dose data in RA in the third quarter of 2026 and in SLE in the fourth quarter. It also expects more velinotamig data before year-end and 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 -10.66% on the market, and are now trading at a price of $11.775. If you want to know more, read the company's complete 8-K report here.

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