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TG Therapeutics Reports Initial Results of CAR T-Cell Therapy for Multiple Sclerosis

TG Therapeutics announced initial results from the Company's Phase 1 study evaluating azercabtagene zapreleucel, an investigational, allogeneic CD19-directed chimeric antigen receptor T-cell therapy, in patients with progressive multiple sclerosis. The data represent the first reported clinical evaluation of an allogeneic CD19-directed CAR T-cell therapy in progressive MS and were presented in a late-breaking oral session at MSToronto2026, the 10th Joint Meeting of the Americas and European Committees for Treatment and Research in Multiple Sclerosis being held October 21-23, 2026, in Toronto, Canada. Late-Breaking Oral Presentation: First Clinical Evaluation of an Allogeneic CD19-Directed CAR T-Cell Therapy in Progressive Multiple Sclerosis: Initial Results from the Phase 1 TG-Azercel-101 Study The presentation includes data from 26 participants with progressive MS treated across six azer-cel dose levels, ranging from 30 million to 500 million CAR T-cells, following bendamustine lymphodepletion. All participants had experienced progression independent of relapse activity within the prior 12 months despite high-efficacy disease-modifying therapy, and all had previously received anti-CD20 therapy. The median baseline EDSS score was 6.0, reflecting substantial disability, with patients typically requiring assistance to walk even relatively short distances. As of the September 3, 2026 data cutoff, median follow-up was 4.9 months, with a range of 0.1 to 15.0 months. Presentation Highlights: Azer-cel demonstrated an encouraging initial safety profile in 26 participants, with no dose-limiting toxicities or high-grade CAR T associated toxicities observed across dose levels including no Grade greater than or equal to3 cytokine release syndrome, Grade greater than or equal to2 immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, immune effector cell-associated hemophagocytic syndrome and no Grade greater than or equal to3 infections. Despite documented progression prior to enrollment, EDSS scores were stable or improved in 89% of evaluable participants at Day 90 and 88% at Day 180. Three participants achieved EDSS improvements of at least 2.0 points at Day 90, including one with a 4.0-point improvement. At Day 90, most evaluable participants demonstrated stable or improved walking performance, upper extremity function and cognitive processing speed, with no gadolinium-enhancing T1 lesions or new or enlarging T2 lesions observed in any of the 22 participants evaluable by MRI. Peripheral blood B-cell counts were depleted to below 10 cells/microL in 96% of participants, and cerebrospinal fluid samples from 21 participants showed a median reduction in CD19-positive B-cell events of 52.3% at Day 10. B-cell reconstitution was observed as early as Day 42 and favored transitional and naive populations. These initial findings are from an ongoing, open-label Phase 1 study and are limited by the small number of participants and short follow-up. Dose escalation and longer-term follow-up are ongoing.

TG Therapeutics Updates BRIUMVI Data at MSToronto2026

TG Therapeutics announced several updated poster presentations at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. The presentations include seven-year follow up data from the ULTIMATE I & II trials, Phase 1 subcutaneous BRIUMVI data, Phase 3 ENHANCE trial data, an update from the ENABLE real world study, and more presentations highlighting BRIUMVI data. Additionally, the abstract is now available for the late-breaking oral presentation highlighting initial results from a Phase 1 study evaluating azer-cel in patients with primary progressive multiple sclerosis. Links to the available data are included below along with key highlights. Michael Weiss, CEO, stated, "The breadth and consistency of the data presented at MSToronto2026 further reinforce our confidence in BRIUMVI as a leading treatment option for relapsing MS. The seven-year results are particularly compelling, with approximately 88% of continuously treated patients remaining free of confirmed disability progression, supported by an increasingly robust body of real-world evidence demonstrating strong disease control, favorable tolerability, and high patient satisfaction. We are also encouraged by emerging evidence from patients transitioning from other anti-CD20 therapies, which continues to inform our understanding of BRIUMVI's differentiated clinical profile. Equally exciting is the progress we are making toward the next generation of BRIUMVI. Our positive Phase 3 ENHANCE results support the potential to simplify IV treatment initiation to a single infusion, while our Phase 1 subcutaneous results provide strong support for the quarterly dosing regimen being evaluated in our fully enrolled Phase 3 trial. Together, these advances have the potential to strengthen our IV franchise while opening an entirely new segment of the anti-CD20 market, positioning BRIUMVI to become an increasingly important treatment option for patients with relapsing MS, regardless of their preferred route of administration."

TG Therapeutics Publishes Long-Term Efficacy Results for BRIUMVI

TG Therapeutics announced the publication of results from a five-year matching-adjusted indirect comparison evaluating long-term relapse activity and disability progression outcomes with BRIUMVI compared with ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis. For the analysis, individual patient data from the Phase 3 ULTIMATE I/II pivotal trials for BRIUMVI were reweighted to match published baseline characteristics from the pivotal studies for ocrelizumab and ofatumumab in patients with RMS, revealing favorable long-term outcomes with BRIUMVI compared to the other two comparators. The manuscript, entitled "Long-Term Comparative Outcomes in Relapse Activity and Disability Progression Among Anti-CD20 Therapies in Relapsing Multiple Sclerosis: An Unanchored Matching-Adjusted Indirect Comparison," was published online in Multiple Sclerosis and Related Disorders. Five-year anti-CD20 outcomes from the pivotal studies of BRIUMVI, ocrelizumab, and ofatumumab were compared using an unanchored MAIC. The analysis used individual patient-level data from 545 BRIUMVI-treated participants in the Phase 3 ULTIMATE I and II trials and their open-label extension and compared outcomes with published aggregate data from the Phase 3 OPERA I/II trials of ocrelizumab and ASCLEPIOS I/II trials of ofatumumab. In the analysis, BRIUMVI patient-level data were re-weighted to align baseline characteristics with the respective comparator trial populations. These adjustments are designed to mitigate the effects of any demographic differences in the study populations on the efficacy results. The findings included: BRIUMVI was associated with a lower risk of 24-week confirmed disability progression compared with both ocrelizumab and ofatumumab, with a 44% lower relative hazard versus ocrelizumab and a 49% lower relative hazard versus ofatumumab. BRIUMVI was associated with a lower cumulative incidence of CDP24 at 240 weeks, with estimated rates of 9.3% versus 16.1% for ocrelizumab and 9.4% versus 17.9% for ofatumumab. BRIUMVI was associated with more time free from confirmed disability progression over 240 weeks, with an average of 8.1 additional weeks compared with ocrelizumab and 13.1 additional weeks compared with ofatumumab. BRIUMVI demonstrated consistently low annualized relapse rates over five years of treatment, with MAIC-adjusted ARR declining from 0.118 in Year 1 to 0.032 in Year 5 in the comparison with ocrelizumab, and from 0.116 to 0.030 in the comparison with ofatumumab. These findings are considered exploratory and require confirmation in direct comparative studies.