Cullinan Therapeutics (NASDAQ: CGEM) has reported clinical data and outlined global clinical development plans for CLN-978, a CD19xCD3 T cell engager, and velinotamig, a BCMAxCD3 T cell engager, in autoimmune diseases.
According to Cullinan, CLN-978 demonstrated potential for immune reset, including remissions in systemic lupus erythematosus and rheumatoid arthritis. Initial velinotamig data show promising clinical activity, including complete renal responses in lupus nephritis, supporting potential in plasma cell-driven autoimmune diseases.
In a statement, Nadim Ahmed, President and CEO of Cullinan, commented, “We continue to build strong momentum across our T cell engager portfolio and are highly encouraged by the compelling data we have generated for our immunology programs, which demonstrate the broader potential of T cell engagers in autoimmune diseases. Importantly, these data also support our strategy to develop differentiated CD19 and BCMA T cell engagers, designed to address the full spectrum of B cell– and plasma cell–driven autoimmune diseases. For CLN-978, our OUTRACE SLE and RA clinical trials show that in heavily pretreated patients, all of whom discontinued background immunosuppressive therapies prior to study entry, CLN-978 achieved clinical remissions and deep B cell depletion, including indicators of immune reset. These data support the potential for CLN-978 to deliver durable, treatment-free remissions in the community out-patient setting, representing a meaningful shift in how these diseases may be managed. With our global clinical footprint, we are prepared to advance quickly into the next phase of development, including planned indication expansion.”
Mr. Ahmed added, “In parallel, velinotamig has demonstrated promising early clinical efficacy, including complete renal responses, with pharmacodynamic effects aligned with its mechanism. Based on these initial observations, we are focused on expanding the current dataset and advancing into additional autoantibody-mediated conditions with high unmet need. Looking ahead, we have a defined path of multiple near-term catalysts anticipated for both programs, with additional multi-dose data for CLN-978 in RA next quarter and in SLE in Q4, and additional data for velinotamig before the end of the year.”
