Cullinan Therapeutics Eyes December Data Catalyst for CLN-978 and CLN-049

Key Points

• CLN-978: Cullinan plans a comprehensive December data update covering multi-dose results in lupus, rheumatoid arthritis and Sjögren’s disease. The company reported sustained B-cell depletion and clinical responses at 20- and 30-microgram doses, while discontinuing the 45-microgram cohort after one Grade 3 cytokine release syndrome case.
• Pipeline catalysts: Partner Genrix Bio is expected to present updated velinotamig lupus data at the November ACR meeting, while Cullinan plans to launch a Phase I autoimmune basket study by early 2027. The company also expects updated CLN-049 leukemia data in December and is preparing a potentially registrational Phase II study.
• Financial position and oncology progress: Cullinan reported more than $350 million in cash as of June 30, enough to fund operations into 2029 under its current plan. Separately, zipalertinib plus chemotherapy showed a statistically significant 50% reduction in progression-free survival risk in first-line EGFR exon 20 lung cancer, with a second-line regulatory decision expected in February 2027.

Cullinan Therapeutics NASDAQ: CGEM outlined upcoming clinical milestones across its immunology and oncology pipeline, including a planned December update for its CD19-directed T-cell engager CLN-978 and data presentations for other programs in November and the fourth quarter.

President and CEO Nadim Ahmed said the company is preparing what it expects to be its most comprehensive clinical data set to date for a CD19 T-cell engager. The December update is planned to include multi-dose data for CLN-978 across systemic lupus erythematosus, rheumatoid arthritis and Sjögren’s disease, along with longer follow-up from single-dose cohorts.

CLN-978 Data Update Planned for December

Cullinan presented initial data for CLN-978 at the European Alliance of Associations for Rheumatology, or EULAR, meeting in June. Chief Medical Officer Jeff Jones said the prior presentation included 32 patients, comprising 21 patients with lupus and 11 with rheumatoid arthritis. Most had received a single target dose, and all had stopped chronic background immunosuppression before enrollment, he said.

Jones said the 20-microgram and 30-microgram dose levels produced marked and sustained peripheral B-cell depletion and were associated with clinical responses. He cited DORIS remissions in lupus and DAS28 remissions in rheumatoid arthritis, as well as what he described as a favorable safety profile at those dose levels.

The company is evaluating repeat dosing intended to support a brief induction-treatment period followed by treatment-free responses. Jones said physicians have indicated that a six-month remission could be clinically meaningful for difficult-to-treat lupus, while three to four months could be meaningful in highly refractory rheumatoid arthritis.

Cullinan discontinued a 45-microgram cohort after seeing one case of Grade 3 cytokine release syndrome, or CRS, at that dose level. Jones said the company observed no CRS above Grade 1 in the majority of cases at the 20-microgram and 30-microgram dose levels, primarily after the initial 10-microgram target dose. He added that early repeat-dose data from six patients treated at 20 micrograms reinforced the safety profile.

The December presentation is expected to provide an initial assessment of multi-dose clinical activity, including whether patients are achieving ESSDAI responses in Sjögren’s disease, DORIS remissions in lupus and DAS28 remissions in rheumatoid arthritis. Ahmed said the data will not yet provide definitive answers on durability for most multi-dose patients because follow-up will remain limited.

Cullinan plans to begin Phase II studies of CLN-978 in early 2027. Jones said the company can proceed under its existing protocols without a regulatory check-in. The Phase II work is expected to include dose and regimen confirmation, as well as evaluation of disease- or organ-specific patient subsets. Cullinan has identified lupus nephritis as one potential area for accelerated development.

BCMA Program to Present Lupus Data at ACR

The company also expects its partner Genrix Bio to present updated data for velinotamig, a BCMA-directed T-cell engager, at the American College of Rheumatology meeting in November. The presentation is expected to include about 12 patients treated at target doses of 10, 20 and 30 micrograms per kilogram in a Phase I dose-escalation study.

Jones said earlier data included complete renal responses in lupus patients with lupus nephritis at the 10-microgram-per-kilogram dose. He contrasted that with a 180-microgram target dose used in multiple myeloma, saying the comparison illustrated the drug’s potency at lower doses in the lupus setting.

Ahmed said Cullinan views CD19 and BCMA as complementary autoimmune targets. The company sees CD19 as more applicable to rheumatic diseases driven by pathogenic B cells, while it sees BCMA as suited to diseases in which plasma cells produce pathogenic autoantibodies.

Cullinan expects to begin a Phase I basket study of velinotamig in autoimmune cytopenias, including immune thrombocytopenia and autoimmune hemolytic anemia, no later than early 2027. Jones said the company may later explore plasma cell-mediated diseases across nephrology, endocrinology and neurology.

Oncology Programs Advance

In oncology, Cullinan said it is preparing to initiate a potentially registrational Phase II study of CLN-049, its FLT3-directed T-cell engager for relapsed or refractory acute myeloid leukemia. Jones said the study could begin “any day now” following what the company described as a successful end-of-Phase I meeting with the Food and Drug Administration.

The company expects to report updated Phase I CLN-049 data in December, including longer-term outcomes for patients previously reported to have achieved complete responses or complete responses with incomplete hematopoietic recovery, as well as data from additional patients treated at higher dose levels. Cullinan also plans to begin a frontline combination study with venetoclax during the fourth quarter, which it said could inform a future Phase III study.

Separately, Cullinan and partner Taiho Oncology are discussing the path toward registration of zipalertinib plus chemotherapy in first-line EGFR exon 20 non-small cell lung cancer. Ahmed said the company recently presented REZILIENT3 data showing what it characterized as potentially practice-changing results in the frontline setting.

Jones said a planned interim analysis showed a statistically significant and clinically meaningful 50% reduction in the risk of death or disease progression based on progression-free survival. He said overall survival data showed a favorable but not yet statistically significant trend. Ahmed emphasized that progression-free survival, rather than overall survival, is the intended registration endpoint.

The new drug application for zipalertinib in the second-line setting, based on REZILIENT1 data, remains under review, with an action date in February 2027, Jones said.

Ahmed said Cullinan had more than $350 million in cash as of June 30 and expects that cash to fund operations into 2029 under its current operating plan. He said the runway includes anticipated regulatory milestone payments from the Taiho collaboration and development plans for the company’s T-cell engager programs.

About Cullinan Therapeutics (NASDAQ:CGEM)

Cullinan Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer and other serious diseases. The company's approach combines internally developed drug candidates with licensed or acquired programs and partnerships intended to address areas of significant unmet medical need.

Its pipeline has included zipalertinib, an oral tyrosine kinase inhibitor being developed for patients with non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations.

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