Cullinan Therapeutics (CGEM) Stifel 2024 Healthcare Conference summary

Portfolio evolution and strategic expansion

• Expanded focus to autoimmune diseases with CLN-978, a CD19xCD3 bispecific T cell engager, receiving FDA IND clearance in the U.S. and Ethics Committee approval in Australia.

• Initiated a global study in SLE, targeting moderate to severe lupus, with initial clinical data expected in Q4 2025.

• Advancing CLN-978 in rheumatoid arthritis, collaborating with leading academic groups in Germany and Italy.

• Oncology pipeline progressing, including CLN-619 (MICA/MICB pathway) and zipalertinib (Exon 20 EGFR inhibitor), with pivotal study data expected mid-next year.

• Maintains a strong cash position of $640 million, providing runway into 2028.

Clinical development and trial design

• SLE trial will use a modified single ascending dose design, starting at 10 micrograms, with four planned dose levels up to 45 micrograms.

• Focus on identifying a B cell depleting dose, using step-up dosing and pre-medication to mitigate cytokine release syndrome risk.

• Enrolling general SLE patients with SLEDAI scores of 8 or higher, excluding severe nephritis and neuropsychiatric lupus.

• Background immunosuppressive therapies that impair T cell function will be washed out before treatment; steroids allowed as bridging therapy.

• Phase 1 endpoints include safety, SLEDAI score reduction, PK/PD, B cell kinetics, and autoantibody impact.

Competitive landscape and differentiation

• CLN-978 is the first CD19 T cell engager with a U.S. IND for autoimmune diseases, providing a leading position.

• High affinity for CD19 and smaller molecular size may enhance tissue penetration and B cell clearance.

• Speed of execution and regulatory progress highlighted as key differentiators.

• Strategic interest in CD19 T cell engagers validated by large pharma activity and external collaborations.

• Early data suggest CLN-978 is more potent in vivo than some competitors.