Cullinan Therapeutics (CGEM) TD Cowen 46th Annual Health Care Conference summary

Strategic milestones and outlook

• 2026 is expected to be a transformational year, with key catalysts across all programs, especially CLN-978 (CD19xCD3 T-cell engager for autoimmune diseases) and CLN-049 (FLT3xCD3 T-cell engager for AML).

• CLN-978 is positioned as a best-in-class candidate with global development in RA, lupus, and Sjögren's disease, with initial clinical data for lupus and RA in Q2, multi-dose RA data in Q3, and Sjögren's data in Q4 of this year.

• CLN-049 offers a first-in-class immunotherapeutic approach for AML, with recent ASH data showing a composite CR rate of 31% at the highest dose, competitive with recent AML approvals.

• Fast Track designation is being leveraged for CLN-978, with a focus on demonstrating treatment-free remissions and broad adoption potential.

• The development path for both programs is designed to be efficient, with monotherapy approaches and systematic dose optimization studies planned.

Clinical development and data expectations

• CLN-978 studies are running parallel dose escalation in SLE and RA, with Q2 data to show dose response for B-cell depletion and safety, and Q3 multi-dose data to inform efficacy in difficult-to-treat RA patients.

• Acceptable safety profile targets include minimizing Grade 2 CRS to 10% or less and preventing neurotoxicity, with Grade 1 CRS considered manageable.

• Efficacy benchmarks for CLN-978 include achieving 20–30% treatment-free remission rates in lupus, which would drive widespread adoption.

• Q2 data will include at least 16 patients (nine SLE, seven RA) at the 30 µg cohort, with potential for higher numbers due to further escalation and backfill.

• Multi-dose data in RA will enable regimen optimization, with regulatory expectations for randomized dose optimization studies across indications.

Oncology program highlights

• CLN-049 addresses a significant gap in AML immunotherapy, with a composite CR rate of 31% at 12 µg/kg, aligning with recent AML drug approvals.

• No biomarker has been identified to predict response, supporting an all-comer strategy, including patients with P53 mutations.

• Expansion plans include two dose levels in relapsed AML and a separate cohort for P53-mutated patients, with monotherapy exploration in untreated P53 AML.

• Dose escalation is expected to wrap up in early 2026, with expansion phase commencing in Q2 this year and six-month follow-up data anticipated by year-end.

• The program aims for accelerated approval pathways if efficacy and safety are compelling, especially in high-risk AML subsets.