Cullinan Therapeutics Inc "Autoimmune KOL Bullish on CLN-978 Ph1 Data in SLE/RA"

Research evidence excerpt

Cullinan Therapeutics Inc "Autoimmune KOL Bullish on CLN-978 Ph1 Data in SLE/RA"

diovascular risk and other comorbidities.

KOL thinks B-cell depletion validates CD19 TCE mechanism and repeat dosing

could improve durability

The KOL viewed the B-cell depletion data as supportive of CLN-978’s CD19 TCE

mechanism, with deeper and faster depletion seen in higher dose cohorts. She noted

that peripheral B-cell depletion was profound in lupus and more dose-dependent in RA,

supporting that CLN-978 is likely “getting the bad actors, or the majority of the bad

actors.” In her view, TCEs may not produce the complete reset seen with CAR-T, but

repeat dosing is a key advantage, as it can maintain depletion longer and potentially

support a better reset. Mechanistically, repeated dosing could either deepen depletion

or more selectively affect the relevant B-cell and plasma cell populations needed for

durable benefit, though the optimal re-dosing schedule remains to be defined.

KOL viewed SLE activity as impressive, especially early DORIS remission

The KOL viewed CLN-978’s SLE activity as impressive, particularly given the early timing

of responses. She noted that some patients were already reaching LLDAS or achieving

≥4-point SLEDAI reductions as early as weeks 4, 8, or 12, which she viewed as “quite

impressive,” especially as lupus responses generally take time to emerge. The KOL was

especially positive on the DORIS remission data, noting that DORIS is a very hard

endpoint to achieve and is not typically seen this early in randomized lupus trials of other

biologics, where such responses are generally observed closer to one year rather than at

12-24 weeks. In this context, seeing 5 patients achieve DORIS remission within 24 weeks

was viewed as quite impressive.