Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Technical Presentation (September 2022)
11 slides from Tonix Pharmaceuticals's technical presentation, Sep 15, 2022
Slide 1: Long-term rejection free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy in nonhuman primates
Long - term rejection free renal allograft survival with Fc - modified anti - CD154 antibody monotherapy in nonhuman primates. Grace Lassiter, MD Background • Triple xeno-antigen knock out (TKO) pigsareexpected to be optimaldonorsfor humanxenotransplantation due to reduced antibody binding from huma
Slide 2: Background
Background CD154 mAb-sCD154 immune complex can activate platelets cp1s4 CISA expressed on platelets upon acthation Fe Receptor binding Site. —] cv Robles-Carilot eta. Immuno! 2010 Osea.
Slide 3: Background
• To date, there has not been a fully human or humanized aCD154 antibody that can effectively prevent transplant rejections, inflammatory conditions or autoimmune conditions with an acceptable level of side effects • Tonix Pharmaceuticals Inc. has developed an Fc - Modified aCD154 with low binding t
Slide 4: Study Overview
0 6w 12w 18w 24w 30w 20mg/kg qw 20mg/kg qw MMF Tacrolimus Group A n=6 Group B n=6 Conventional I.S n=20 Twelve Transplants have been Completed & Compared with Historical Results Steroids MMF No I.S n=4 Study Overview
Slide 5: Results: Kaplan-Meier Survival Curve
0 50 100 150 200 0 50 100 Renal Allograft Survival Days Post-TX P r o b a b i l i t y o f S u r v i v a l Group A (n=6) Group B (n=6) Conventional I.S. (n=20) No I.S. (n=4) Results: Kaplan - Meier Survival Curve
Slide 6: Results: Histopathology
Group A NHP (1) biopsy at day 180 post transplant C4d negative Group A NHP (2) biopsy at day 169 post transplant C4d negative Results: Histopathology
Slide 7: Results: Adverse Effects
• No increased incidence of thrombosis seen • No other evidence of end organ damage noted on Necropsy Results: Adverse Effects
Slide 8: Results: Platelet Activation
Results: Platelet Activation Antibody Conc. 1 Conc. 2 Conc. 3 Conc. 4 Conc. 5 5c8 500 500 - - - TNX1500 - - 500 500 - Soluble CD154 1500 - 1500 - 1500 nM ME THODS Flow cytometric analysis for platelet activation after anti-CD154:soluble-CD154 immune complex (IC) stimulation Monkey whole blood (M3322
Slide 9: Results: Platelet Activation
Results: Platelet Activation PAC-1 C D 6 2 P All conditions 5c8:sCD154 IC 5c8 TNX:sCD154 IC TNX sCD154 Specific staining Negative control Unstimulated FSC (Log) S S C ( L o g ) CD61 C D 6 2 P 5c8:sCD154 IC TNX:sCD154 IC RE SUL TS Platelet activation status after incubation with CD154:sCD154 IC 22082
Slide 10: Conclusion
Conclusion • Fc - Modified aCD154 is well tolerated and can be an effective alternative to conventional immunosuppression therapy in nonhuman primates. ▪ TNX - 1500 in combination with MMF resulted in an increased rate of graft failure compared to monotherapy ▪ Optimal dosage remains to be defined
Slide 11: Acknowledgements and Questions
Takayuki Hirose Ryo Otsuka Ahmad Karadagi Toshi Tomosugi Kohei Kinoshita Abbas Dehnadi Cindy Miller Jane O Franzi Pollok R.N. Pierson, III A.Benedict Cosimi Tatsuo Kawai Knight Surgery Research Laboratory Jessica Burke Anet Calisir Nick Deluca Nelson Marquez Carvajal Eli Smith Michael Duggan MGH Pat
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