TG THERAPEUTICS

Roche announced that its Phase 3 MUSETTE trial testing a high-dose version of Ocrevus (ocrelizumab) failed to show additional benefit in slowing disability progression in relapsing multiple sclerosis patients.

TG Therapeutics will showcase data from ULTIMATE I & II Phase 3 trials and ENHANCE Phase 3b trial evaluating BRIUMVI in relapsing multiple sclerosis at the upcoming ACTRIMS forum in Florida.

• TG Therapeutics has secured access to MaxCyte's flow electroporation technology to develop azercabtagene zapreleucel, an off-the-shelf CAR T-cell therapy for progressive multiple sclerosis. • The Phase 1 clinical trial will evaluate azer-cel in up to 32 patients with progressive MS forms, focusing on determining optimal dosing and safety profiles. • This innovative therapy targets CD19-expressing B-cells using donor-derived T-cells, potentially reducing MS-driving autoantibodies while avoiding graft-versus-host disease complications.

TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (RMS).

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

Several drugs approved under the FDA's accelerated approval pathway have been withdrawn from the market due to safety concerns or failure to confirm clinical benefit.

Phase 3b ENHANCE study reveals that 30-minute infusions of BRIUMVI (ublituximab-xiiy) are well-tolerated in patients with relapsing forms of multiple sclerosis (RMS).

Industry leaders and researchers gather at the inaugural Next Generation Kinase Inhibitors Summit to advance drug development for enhanced specificity and durability in cancer treatment.