Tg Therapeutics, Inc. · NASDAQ:TGTX
Tg Therapeutics — 10th Joint ACTRIMS-ECTRIMS Meeting 2026
15 slides from Tg Therapeutics's conference presentation, Oct 23, 2026
Slide 1: First Clinical Evaluation of an Allogeneic CD19-Directed CAR T-Cell Therapy in Progressive MS
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 Daniel Ontaneda1, Rana Zabad2, Jennifer Graves3, Tirisham Gyang4, Rebecca S. Farber5, Lisa Stropp6, Andrew Goodman7, Ahmed Z. Obeidat8
Slide 2: Disclosures
Disclosures Dr. Ontaneda has received research support from the National Institutes of Health, National Multiple Sclerosis Society, Patient-Centered Outcomes Research Institute, Race to Erase MS Foundation, Genentech, Genzyme, Bristol Myers Squibb, and Novartis, and consulting fees from Ardanza Biop
Slide 3: Progressive MS: Unmet Need
Progressive MS: Unmet Need Current State of Treatment in Progressive MS Putative Rationale for CAR T-Cell Treatment • Disability can accumulate • Deep B-cell depletion across independent of relapse activity peripheral and tissue (PIRA)1,2 compartments, including the CSF • Limited approved treatment
Slide 4: Azer-cel: Allogeneic Anti-CD19 CAR T-Cell Therapy
Azer-cel: Allogeneic Anti-CD19 CAR T-Cell Therapy Azercabtagene zapreleucel “Off-the-Shelf” CAR T1 • Healthy donor-derived, manufactured and banked • Available without patient-specific manufacturing CAR T Engineering2 • ARCUS-mediated CAR insertion at the TRAC locus • TCR disruption designed to redu
Slide 5: TG-Azercel-101 Study Design
TG-Azercel-101 Study Design Phase 1, open-label, dose-escalation study in progressive MS* Follow-up LYMPHODEPLETION DLT EVALUATION FOLLOW-UP SCREENING • Age 18–60 years • EDSS • EDSS 3.0–6.5 • T25FW DL1 to DL6: • SDMT • Progressive MS • PPMS 30 to 500 × 10⁶ CAR T cells • 9HPT Bendamustine Primary en
Slide 6: Baseline Characteristics
Baseline Characteristics All 26 participants had PIRA in the prior 12 months; all had prior anti-CD20 therapy Baseline Characteristic Participants (N = 26) Age, years, median (range) 51.5 (36–59) Female, n (%) 13 (50%) PPMS / naSPMS / aSPMS, n (%) 9 (35%) / 10 (38%) / 7 (27%) Years since MS diagnosi
Slide 7: Primary and Secondary Safety Endpoints
Primary and Secondary Safety Endpoints No DLTs, Grade ≥3 CRS, Grade ≥2 ICANS, GvHD, or IEC-HS in 26 participants Safety Outcome Participants, n/N (%) DLT None CRS, any grade 2/26 (7.7%) • Grade 1 1/26 (3.8%) • Grade 2 1/26 (3.8%) • Grade ≥3 None ICANS, any grade 2/26 (7.7%) • Grade 1 2/26 (7.7%) • G
Slide 8: Safety Endpoints by Dose Level
Safety Endpoints by Dose Level No apparent dose-related trend in CAR T-associated toxicities, supporting ongoing dose escalation DL1 DL2 DL3 DL4 DL5 DL6 Total Safety Outcome 30 × 10⁶ cells 70 × 10⁶ cells 140 × 10⁶ cells 210 × 10⁶ cells 350 × 10⁶ cells 500 × 10⁶ cells (N) Participants, n 1 3 9 8 4 1
Slide 9: PK/PD: Azer-cel Exposure and B-Cell Depletion
PK/PD: Azer-cel Exposure and B-Cell Depletion PK: Azer-cel detected in 24/24 evaluable participants, peaking at Day 1–3 across dose levels PD: CD19+ B-cell depletion in blood and CSF A. Peripheral Blood CD19+ B Cells B. CSF CD19+ B Cells 25/26 (96%) reached <10 CD19+ B cells/µL Median: 9 → 4 CD19+ B
Slide 10: Early CSF Biomarkers Through Day 10
Early CSF Biomarkers Through Day 10 No median increase in neuroaxonal injury or intrathecal IgG synthesis at Day 10 A. CSF NfL B. Unique CSF OCBs Median: 2,900 → 2,500 pg/mL Median: 2 → 2 14/18 (78%) unchanged or decreased 17/22 (77%) unchanged or decreased 14,000 14 12,000 12 Unique CSF OCBs 10,000
Slide 11: Clinical Outcomes at Day 90 and MRI at Day 60
Clinical Outcomes at Day 90 and MRI at Day 60 Most evaluable participants were stable or improved across clinical and MRI measures Stable or Improved Stable Worsened improved EDSS 16/18 T25FW 16/17 9HPT 17/18 SDMT 14/18 MRI lesions (Day 60) 22/22 Improved/worsened: EDSS ≥1.0-point decrease/increase
Slide 12: Change in EDSS Following Azer-cel
Change in EDSS Following Azer-cel Most participants stable or improved through Day 180 7.0 EDSS stable or improved 6.5 ━━ Median Day 90 6.0 6.0 ━━ Individual participants 5.5 16/18 5.5 5.0 4.5 Day 180 4.0 −2.0 points through Day 450 (~15 months) 7/8 3.5 3.0 Day 270 2.5 3 improved ≥2.0 points at Day
Slide 13: B-Cell Reconstitution Enriched for Transitional and Naïve Phenotypes
B-Cell Reconstitution Is Enriched for Transitional and Naïve Phenotypes With Fewer Switched Memory B Cells; VZV Humoral Immunity Is Preserved Antigen-inexperienced Memory Transitional B cells Naïve B cells Switched memory B cells Anti-VZV IgG CD27− IgD+ CD10+ CD27− IgD+ CD10− CD27+ IgD− Green: n ser
Slide 14: Conclusions
Conclusions • TG-Azercel-101 is the first reported clinical evaluation of an allogeneic CD19- directed CAR T-cell therapy in progressive MS. • Azer-cel demonstrated an encouraging safety profile to date. No DLTs or high-grade CAR T-associated toxicities were observed across dose levels, including no
Slide 15: Acknowledgements
Acknowledgements Study TG-Azercel-101 requires a multidisciplinary effort. We would like to thank our neurology, hematology-oncology, and cellular therapy investigators, coordinators, nurses, laboratory, and study teams for their key contributions. And most importantly, we are deeply grateful to the
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