CLN-978 in SLE and RA Dose Escalation Data Show Earlier-than-Expected Clinical Remissions and Manageable Safety; Multi-Dose RA Data and BCMAxCD3 TCE Clinical Data Expected at June 10 Immunology Day. Estimates Under Review.

研报英文原文证据摘录

CLN-978 in SLE and RA Dose Escalation Data Show Earlier-than-Expected Clinical Remissions and Manageable Safety; Multi-Dose RA Data and BCMAxCD3 TCE Clinical Data Expected at June 10 Immunology Day. Estimates Under Review.

ry multi-dose

data expected at Immunology Day on June 10. There is a large, underserved post-TNF, pre-JAK segment of the RA market thatRESEARCH could be addressed with a potent (and practical) B-cell depleting approach. A case series published in 2024 (Bucci et al) featured

6/6 refractory RA patients treated with another CD19xCD3 TCE (blinatumomab; Amgen [AMGN, Not Rated]) with significant

clinical responses. CGEM is currently collaborating with RA experts at FAU Erlangen-Nuremberg and Università Cattolica del

Sacro Cuore, Rome on the first clinical trial of CLN-978 in RA patients that is now enrolling. Based on our interactions with KOLs

during ACR, we believe CLN-978 could be meaningfully used in post-JAK and post-TNF/pre-JAK segments of the RA market, which

represent a total TAM of >500k patients in the US alone.

Ianalumab provides clinical validation of B-cell depleting approaches in Sjogren's disease. Ianalumab is an anti-BAFF-R

being developed by Novartis (NVS, Not Rated) in a number of autoimmune conditions, with Sjogren’s disease as the lead

indication. In August 2025, Novartis reported positive topline results from two Phase 3 trials in Sjogren’s disease. We note the

improvement seen in these studies is viewed as incremental over background therapy, presenting an opportunity for B-cell

depleting approaches (e.g., CLN-978) that could potentially offer deeper depletion to further improve efficacy.

CLN-978 could emerge as the best-in-class CD19xCD3 TCE enabled by its wider therapeutic index (10x more potency for B-cell

depletion vs.