CGEM Cullinan Therapeutics, Inc.
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Executive Summary
Cullinan Therapeutics presented initial Phase 1 data for CLN-978 (CD19xCD3 T cell engager) in SLE and RA at EULAR 2026. In 29 patients, the drug showed clinical benefit including remissions, deep B cell depletion, and a manageable safety profile up to 30 µg target doses. The company also announced an Immunology Day on June 10 for additional data, including the first RA multi-dose cohort and initial velinotamig data.
Actionable Insight
The initial Phase 1 data are encouraging with clear efficacy signals and manageable safety, supporting CLN-978's potential in autoimmune diseases. Watch the Immunology Day on June 10 for the RA multi-dose cohort and velinotamig data, which could further de-risk the platform. Interim data are early and subject to change with longer follow-up.
Key Facts
- Initial Phase 1 data from 29 patients (18 SLE, 11 RA) as of May 15, 2026
- In SLE: 71% (10/14) achieved ≥4-point hSLEDAI reduction; 5 achieved DORIS remission
- In RA: 71% (5/7) showed disease activity improvement; 1 DAS28-ESR remission at 30 µg
- Peripheral B cell depletion >80% in 82% (14/17) of SLE patients; BLOQ in 50% at ≥20 µg
- BLOQ B cell depletion in 67% (4/6) of RA patients at ≥20 µg; tissue depletion also observed
- Safety: mostly Grade 1 CRS; one Grade 3 CRS at 45 µg (cohort discontinued); no ICANS
- Immunology Day on June 10 to present RA multi-dose data and initial velinotamig data
Financial Impact
No financial data provided; pre-revenue clinical-stage biotech. Positive early efficacy/safety data supports pipeline value.
Risk Factors
- Interim data from small sample (n=29); results may change with more patients and longer follow-up
- Grade 3 CRS at 45 µg led to cohort discontinuation; multi-dose safety not yet fully characterized
- No financial data in filing; pre-revenue biotech with no approved products
- Forward-looking statements only; no hard guidance or quantitative financial metrics
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-260640 |
| Document: cgem-20260606.htm | 0001193125-26-260640 |
| Document: 0001193125-26-260640-index-headers.html | 0001193125-26-260640 |
| Document: 0001193125-26-260640-index.html | 0001193125-26-260640 |
| Document: 0001193125-26-260640.txt | 0001193125-26-260640 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
2d ago
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Institutional Cluster
| $12.04 awaiting T+5 | awaiting T+5 | — | $13.70 (+13.79%) |
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Jun 10, 2026
3d ago
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Press Release
| $13.20 awaiting T+5 | awaiting T+5 | — | $13.70 (+3.79%) |
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Jun 8, 2026
5d ago
|
8-K
| $13.51 awaiting T+5 | awaiting T+5 | — | $13.70 (+1.44%) |
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May 19, 2026
25d ago
|
Press Release
| $14.18 $15.52 | ▲ +9.49% | ▲ +7.19% | $13.70 (−3.35%) |
|
May 18, 2026
25d ago
|
8-K
| $14.18 $15.52 | ▲ +9.49% | ▲ +7.19% | $13.70 (−3.35%) |
|
May 18, 2026
25d ago
|
Press Release
| $14.18 $15.52 | ▲ +9.49% | ▲ +7.19% | $13.70 (−3.35%) |
|
Mar 10, 2026
13w ago
|
Press Release
| $14.91 $13.44 | ▼ −9.86% | ▼ −8.95% | $13.70 (−8.12%) |
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Feb 24, 2026
15w ago
|
Insider Cluster
| $14.27 $15.73 | ▼ −10.23% | ▼ −11.26% | $13.70 (+3.99%) |
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Feb 24, 2026
15w ago
|
Insider Cluster
| $14.27 $15.73 | ▼ −10.23% | ▼ −11.26% | $13.70 (+3.99%) |
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Feb 24, 2026
15w ago
|
Insider Cluster
| $14.27 $15.73 | ▼ −10.23% | ▼ −11.26% | $13.70 (+3.99%) |
US Market Status
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