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

Strategic milestones and program updates

• 2026 anticipated as 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 molecule with global development in RA, lupus, and Sjögren's disease; initial clinical data for lupus and RA expected in Q2 2024, multi-dose RA data in Q3, and Sjögren's data in Q4.

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

• Fast Track designation is being leveraged for accelerated development, with a focus on systematic, company-sponsored studies to establish safety and efficacy benchmarks.

• Expansion cohorts for CLN-049 will begin in Q2 2024, targeting both all-comer relapsed AML and P53-mutated subgroups.

Clinical development insights and expectations

• CLN-978 studies are designed to provide comprehensive dose-response and PK/PD data, with initial single-dose results in Q2 2024 and multi-dose RA data in Q3.

• Acceptable safety profile targets less than 10% Grade 2 CRS and minimal neurotoxicity; efficacy aims for 20–30% treatment-free remission in autoimmune indications.

• Dose optimization and regimen refinement are ongoing, with regulatory expectations for randomized dose-finding studies across indications.

• For CLN-049, no biomarker-based patient selection is currently needed; efficacy appears consistent across AML subgroups, including P53-mutated patients.

• By year-end, six-month follow-up data for responding AML patients will be available, supporting further regulatory and clinical strategy.

Industry context and competitive landscape

• B-cell depletion and T-cell redirecting therapies are highlighted as hot areas, with recent high-profile acquisitions and mergers in the space.

• Current autoimmune treatments require chronic immunosuppression, while T-cell engagers offer potential for treatment-free remission and monotherapy efficacy.

• The development path for T-cell engagers in autoimmune diseases is expected to be more efficient than monoclonal antibodies due to monotherapy potential.

• In AML, immunotherapy has lagged behind other hematologic malignancies, making CLN-049's progress particularly notable.

• Regulatory pathways for accelerated approval are being explored, especially for high-need subgroups like P53-mutated AML.