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TG Therapeutics to reveal first azer-cel MS trial data at MSToronto2026

TG Therapeutics to reveal first azer-cel MS trial data at MSToronto2026 GenoMethods.org © genomethods.org
TG Therapeutics to reveal first azer-cel MS trial data at MSToronto2026 © genomethods.org
Initial Phase 1 results for azer-cel in progressive multiple sclerosis will break cover at MSToronto2026, alongside new BRIUMVI findings. TG Therapeutics aims to push its B-cell therapy ambitions into the spotlight.

For the first time, an allogeneic CD19-directed CAR T-cell therapy will be put under the microscope in progressive multiple sclerosis. TG Therapeutics plans to present early clinical data from its azer-cel program at MSToronto2026, with the late-breaking oral session set for October 23, 2026. The Phase 1 TG-Azercel-101 study marks a new chapter for cell therapy in this patient group.

The company's official schedule places the azer-cel abstract (Toronto-LBA-229) under the leadership of Daniel Ontaneda from Cleveland Clinic Mellen Center. TG Therapeutics confirmed the abstract will go public on October 21, with the oral slot running from 10:45 to 10:55 a.m. Eastern on October 23. No efficacy or safety numbers have surfaced yet. Independent sources have not verified clinical benefit for azer-cel in PPMS.

The azer-cel Phase 1 study represents the first clinical evaluation of an allogeneic CD19-directed CAR T-cell therapy in patients with progressive multiple sclerosis.

TG Therapeutics

BRIUMVI data push: long-term and real-world evidence

While azer-cel draws attention, TG Therapeutics is also rolling out new data on BRIUMVI® (ublituximab-xiiy), its anti-CD20 monoclonal antibody for relapsing MS. The company will highlight seven-year clinical outcomes and real-world experience with intravenous BRIUMVI, plus findings on a single-dose start regimen. Full Phase 1 data for subcutaneous BRIUMVI will be shared, as TG Therapeutics looks to expand administration routes and reinforce the therapy's safety and efficacy claims.

The MSToronto2026 program lists BRIUMVI presentations spanning both trial and real-world data. However, the company has not published seven-year outcome figures or a complete subcutaneous dataset. Poster authors include Bruce Cree, Carrie Hersh, Derrick Robertson, Nancy Monson, Krzysztof Selmaj, Barry A. Singer, Gabriel Pardo, and Anke Salmen, signaling broad clinical involvement.

Michael S. Weiss, Chairman and CEO, called out the scope of the BRIUMVI data, saying it "further expands the growing body of evidence supporting BRIUMVI in MS" and "solidify the efficacy, safety and tolerability profile of BRIUMVI." TG Therapeutics will also discuss B-cell biology and patient transitions to BRIUMVI, aiming to carve out a stronger position in the MS treatment market.

The ENHANCE study evaluated a simplified dosing regimen for BRIUMVI, transitioning from an initial two-step infusion (150 mg on day 1 and 450 mg on day 15) to a single 600 mg infusion on day 1, demonstrating bioequivalence and a comparable safety profile. This dosing change is part of a separate program and is not related to the azer-cel study.

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Conference timing and safety notes

MSToronto2026 runs October 21–23 in Toronto. Regular abstracts are already online, but late-breaking data—including the azer-cel Phase 1 results—will drop October 21. The azer-cel oral session lands on October 23. No numerical efficacy or safety outcomes for azer-cel have been released by TG Therapeutics or outside investigators.

BRIUMVI holds approval in the U.S. and other countries for adults with relapsing MS. The drug is built for rapid B-cell depletion at low doses. Safety risks include infusion reactions and infections, as well as hepatitis B reactivation and progressive multifocal leukoencephalopathy. Full safety details are available through the company's official channels.

TG Therapeutics is betting on azer-cel's first clinical data in progressive MS and a broad BRIUMVI evidence package to raise its profile in B-cell therapy. The company is pushing CAR T-cell technology into new territory and shoring up its commercial base with long-term and real-world results. Competitors will have to match both innovation and clinical staying power.

Elena MacLeod Clinical biotechnology and CAR-T editor GenoMethods.org
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Elena MacLeod

Elena MacLeod is Clinical Biotechnology Editor at GenoMethods, covering CAR-T, engineered cell therapies, gene therapy, clinical trials, cancer immunology and regulatory developments. Her evidence-first reporting focuses on trial design, patient populations, safety, efficacy, response durability and the limitations that determine how early clinical results should be interpreted.