TG Therapeutics, Inc. · NASDAQ:TGTX

TG Therapeutics — Technical Presentation (2015)

13 slides from TG Therapeutics's technical presentation, 2015

  1. Slide 1: Safety and Activity of the Chemotherapy-free Triplet of Ublituximab, TGR-1202, and Ibrutinib

    Safety and Activity of the Chemotherapy-free Triplet of Ublituximab, TGR-1202, and Ibrutinib in Relapsed B-cell Malignancies Nathan Fowler, MD1, Loretta Nastoupil, MD1, Matthew Lunning, DO2, Julie Vose, MD2, Tanya Siddiqi, MD3, Christopher Flowers, MD4, Jonathon Cohen, MD4, Marshall T. Schreeder, MD

  2. Slide 2: Ublituximab: Glycoengineered Anti-CD20 mAb

    Ublituximab: Glycoengineered Anti-CD20 mAb  Type 1 chimeric IgG1 mAb  Unique binding sequence on CD20 (Green arrows in figure)  Potential advantages over current standards of care:  Glycoengineered for enhanced ADCC  Activity in “low” CD20 expressing cell lines  Single agent responses observed

  3. Slide 3: B-Cell Receptor Signaling in Lymphoma

    B-Cell Receptor Signaling in Lymphoma Antigen B Cell Receptor Cytokine TLR CK Receptor C D C C 1 D D B A 9 7 7 PIP2 PIP3 9 9 PI3K mTORC2 PLYN P JAK1 P BTK P SYK DAG AKT P STAT PLCγ IP3--Ca++ MYD88 BLNK PKCβ mTORC2 P Protein CARD11 P Bcl10 synthesis ERK MALT1 IkB IkB NFkB Proteosomal Degradation PROS

  4. Slide 4: TGR-1202: Novel PI3K delta Inhibitor

    TGR-1202: Novel PI3K delta Inhibitor  PK profile that allows once-daily oral dosing  93% nodal PR rate in patients with rel/ref CLL1 1Burris et al, ASCO 2015, Abstract # 7069

  5. Slide 5: TGR-1202 + Ublituximab Doublet

    TGR-1202 + Ublituximab Doublet • 55 patients treated to date Percent Change from Baseline in Disease Burden 25% • 60% ≥3 prior therapies • 51% refractory to prior CLL/SLL RT Indolent NHL DLBCL 0% therapy • Combination well tolerated -25% • Minimal Gr. 3/4 AE’s -50% • Clinical activity demonstrated i

  6. Slide 6: Trial Design: TGR-1202 + Ublituximab + Ibrutinib

    Trial Design: TGR-1202 + Ublituximab + Ibrutinib Ublituximab Ibrutinib TGR-1202 Relapsed Scans at Wk 8 CLL: 420mg Cohort 1 B-NHL & 900mg then q 12 wks CLL NHL: 560mg 400 mg Follow until PD Cohort 2  3 + 3 dose escalation design (CLL and NHL) 600 mg Endpoints:  No limit on prior # of therapies Coho

  7. Slide 7: Demographics: TGR-1202 + Ublituximab + Ibrutinib

    Demographics: TGR-1202 + Ublituximab + Ibrutinib Evaluable for Safety (n) 16 Evaluable for Efficacy† (n) 13 Median Age, years (range) 63 (51 – 85)  100% of CLL had 17p and/or 11q del Male/Female 12/4 ECOG, 0/1/2 5/8/3  4/5 FL/MZL pts had > 4 prior lines of Prior Treatment Regimens, median treatmen

  8. Slide 8: Safety: Cohort Summary

    Safety: TGR-1202 + Ublituximab + Ibrutinib Cohort Summary  CLL and NHL cohorts evaluated separately NHL Pts # DLT CLL Pts # DLT 1: Ublituximab 900mg Ibrutinib 420/560mg + TGR-1202 400 mg 3 0 5 1* 2: Ublituximab 900mg Ibrutinib 420/560mg + TGR-1202 600 mg 4 0 0 0 4 0 0 0 3: Ublituximab 900mg Ibrutin

  9. Slide 9: Safety: Adverse Events

    Safety: TGR-1202 + Ublituximab + Ibrutinib AE’s (at least possibly related) in > 1 Patient N=16 All Grades Grade 3/4 Adverse Event n (%) n (%) Infusion reaction 4 (25%) - Diarrhea 3 (19%) - Nausea 3 (19%) - Fatigue 3 (19%) - Rash 3 (19%) - Anemia 2 (13%) - Neutropenia 2 (13%) 1 (6%) Leukopenia 2 (13

  10. Slide 10: Activity in NHL: TGR-1202 + Ublituximab + Ibrutinib

    Activity in NHL: TGR-1202 + Ublituximab + Ibrutinib BEST PERCENT CHANGE FROM BASELINE IN DISEASE BURDEN 25% 0% * * * * * * * * * * -25% (4.5) (2.5) (3.5) (7) (9.5) (4.5) (7) (8) (7) (9.5) -50% PR PR -75% PR PR On Study PR * (X) Months On Study PR PR PR CR -100% Richter's DLBCL DLBCL FL CLL MCL FL FL

  11. Slide 11: "Triplet": Clinical Response at First and Second Assessment

    “Triplet”: TGR-1202 + Ublituximab + Ibrutinib Clinical Response at First (8 week) and Second (20 week) Assessment (All patients who had second assessment shown) FL FL MZL CLL SLL MCL 0% -10% * * -20% -30% -40% -50% -60% -70% -80% -90% Week 8 Scan Week 20 Scan -100% * Durable PR (9+ months) in an ibr

  12. Slide 12: Conclusions

    Conclusions  The biologic combination of Ublituximab, TGR-1202 + Ibrutinib is safe in patients with relapsed B cell malignancies.  800 mg cohort of TGR-1202 in NHL enrolled  400mg cohort of TGR-1202 in CLL continues to enroll  One DLT was observed in a CLL for re-activated varicella  patient re

  13. Slide 13: Acknowledgements

    Acknowledgements  Thank you to the patients and families for their participation.  Participating Centers • MD Anderson Cancer Center • City of Hope – Loretta Nastoupil, MD – Tanya Siddiqi, MD – Jan Burger, MD, PhD – Robert Chen, MD – Susan O’Brien, MD • Emory • UNMC – Christopher Flowers, MD – Jul

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