Cullinan Therapeutics (CGEM) Stifel 2026 Healthcare Conference 2026 summary

Portfolio and near-term milestones

• Three clinical-stage T-cell engagers span oncology and immunology; key data and development milestones are expected over the coming weeks, months and into 2027.

• CLN-978 multi-dose data are planned for December; velinotamig’s global Phase I/II autoimmune cytopenia study has cleared its IND in the U.S. and Australia.

• Zipalertinib frontline submission is underway with Taiho; the collaboration includes $130 million in regulatory milestones and a 50/50 U.S. profit share.

CLN-978 in autoimmune diseases

• EULAR single-dose data showed clinical remissions, disease-biomarker effects and immune-reset markers, exceeding expectations; December data will assess multi-dose activity, safety and biomarkers.

• December update expected to cover ~20 patients across SLE, RA and Sjögren’s, including 20- and 30-microgram doses; Sjögren’s includes single- and multi-dose data.

• Earliest single-dose cohorts in SLE and RA will have at least six months’ follow-up; durability of patient responses will continue to be tracked into 2027.

• Doses of 20 and 30 micrograms showed mostly grade 1 CRS, one grade 2 case and one grade 3 case; higher-dose escalation is not the current focus, and multi-step-up dosing may mitigate CRS risk.

• Phase II planning will assess multiple doses or schedules for consistent deep B-cell depletion and preserved therapeutic index; plans include a lupus nephritis cohort, while RA development may test both refractory and earlier-line populations.

Velinotamig and autoimmune strategy

• Genrix Bio presented BCMA proof-of-concept data in SLE at ACR; velinotamig targets long-lived plasma-cell-driven disease, complementing CLN-978’s broader B-cell depletion strategy.

• The global Phase I/II study starts in autoimmune cytopenias; nephrology, neurology and endocrinology are among potential additional areas, and development may advance rapidly based on Genrix Bio’s initial China data.

• Subcutaneous administration is being studied for autoimmune cytopenias; IV data showed no CRS above grade 1 with an optimal step-up schedule starting at 3 micrograms/kg.