TG Therapeutics (TGTX): Azer-cel's Early PMS Data Looks Encouraging

At MSToronto this week, TG Therapeutics presented several updates from its core Briumvi franchise and the early-stage allogeneic CD19 CAR-T program (azer-cel). Two were particularly notable: (1) the subQ Briumvi PK/PD Phase 1 study evaluating subQ doses relative to the approved IV reference in RMS, with the overall profile across key metrics such as GMR versus IV, B-cell depletion and safety looking supportive and de-risking for the ongoing Phase 3 heading into a readout by year-end or early next year; and (2) early Phase 1 azer-cel data in PMS showing a clean safety profile and encouraging proof-of-concept. Full Phase 1 data de-risk the 400mg subQ regimen being evaluated in Phase 3: no T1 Gd-enhancing lesions were observed at Week 24 or Week 48, all patients remained lesion-free, and safety continues to look in line with IV. In the '101 trial in progressive MS, across 26 patients there were no high-grade CRS, ICANS or IEC-HS events;