Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Technical Presentation (June 2022)
20 slides from Tonix Pharmaceuticals's technical presentation, Jun 9, 2022
Slide 1: American Transplant Congress 2022, Boston
THE SCIENCE AMERICAN TRANSPLANT CONGRESS sme’ ATCOQ20 JUNE 4-8, 2022 / BOSTON, MA JOHN B. HYNES CONVENTION CENTER
Slide 2: Financial Disclosures
Financial Disclosures • Funding is provided for these studies via NIH Grants and Tonix Pharmaceuticals Inc.
Slide 3: Long-term rejection free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy
Long - term rejection free renal allograft survival with Fc - modified anti - CD154 antibody monotherapy in nonhuman primates. Grace Lassiter, Takayuki Hirose, Ashley D’Attilio, Ryo Otsuka, Ahmad Karadagi, Toshihide Tomosugi, Tatsuo Kawai
Slide 4: Background
Background • Current immunosuppressive regimens have significant side effects • Nephrotoxicity • Steroid induced diabetes • Cytopenia • Increased risk of infection • etc… • Belatacept is currently the only FDA approved costimulatory blockade alternative to calcineurin inhibitors. • Higher rate of ac
Slide 5: aCD154 / CD40L
aCD154 / CD40L • In 1999 Allan Kirk et al. tested a novel monoclonal antibody blocking the costimulatory signal in nonhuman primates (hu5c8 aCD154) • This therapy progressed to a phase IIb clinical trial but was halted due to increased incidence of thromboembolic events
Slide 6: aCD154 mAb-sCD154 immune complex can activate platelets
JUNE 4-8, 2022 / BOSTON, MA = atcmeeting.org D154 mAb-sCD154 immune complex can activate platelets D154 sCD154 p1s4 (154 expressed on 7 platelets upon activation Fe Receptor binding Site Robles-CariloLet al.) Immuno! 2010
Slide 7: Fc-Modified aCD154 with low binding to FcγRIIa (TNX-1500)
• 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 8: Study design: twelve transplants compared with historical results
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
Slide 9: Kidney Transplant Group A Immunosuppressive Regimen
0 2 7 12 - > q7 - 10 days till EOS at 180 days Kidney Transplant Group A Immunosuppressive Regimen N = 6 Fc - Mod aCD154 (20mg/kg)
Slide 10: Kidney Transplant Group B Immunosuppressive Regimen
0 2 7 12 - > q7 days till 6weeks then q14days till EOS at 180 days Fc - Mo d aCD 154 (20mg/k g) Mycophenolate Mofetil 100mg PO BID (25mg/kg) Kidney Transplant N = 6 Group B Immunosuppressive Regimen
Slide 11: Conventional Immunosuppressive Regimen
Methylprednisolone 1mg IM Daily Mycophenolate Mofetil 100mg PO BID (25mg/kg) Tacrolimus 0.1mg/kg IM daily (titrated) Kidney Transplant N = 20 Conventional Immunosuppressive Regimen
Slide 12: No Immunosuppressive Regimen
Kidney Transplant N = 4 No Immunosuppressive Regimen
Slide 13: Renal Allograft Survival
JUNE Renal Allograft Survival Le, 50 100 150 200 Days Post-TX atcmeeting. Group A (n=6) Group B (n=6) Conventional I.S. (n=20) No LS. (n=4) tk t
Slide 14: Group A biopsies C4d negative
Group A NHP (1) biopsy at day 180 post transplant C4d negative Group A NHP (2) biopsy at day 169 post transplant C4d negative
Slide 15: No increased incidence of thrombosis
• No increased incidence of thrombosis seen • No other evidence of end organ damage noted on Necropsy
Slide 16: Renal allograft survival by group
Group TNX - 1500 MMF Tac Pred Renal allograft survival (days) A weekly - - - >180,>180, >180, >180, >160, 28 B weekly for 6 weeks, followed by every 2 weeks daily - - >180, >167, >125, 111, 36, 48 Conventional I.S. - daily daily daily >120, >120, >120, >120, >120, >120, >120, >120, >120, >120, >120,
Slide 17: Renal allograft survival with rapid rejectors
Group TNX - 1500 MMF Tac Pred Renal allograft survival (days) A weekly - - - >180,>180, >180, >180, >159, 28 Rapid rejectors B weekly for 6 weeks, followed by every 2 weeks daily - - >180, >166, >124, 111, 36, 48 Conventional I.S. - daily daily daily >120, >120, >120, >120, >120, >120, >120, >120, >
Slide 18: TNX-1500 Levels
JUNE 4-8, 2022 / BOSTON, MA = atcmeeting.org TNX-1500 Levels * pvalue <0.05 * 2000000: = . * Long term survivor E id Rek ‘B® 1500000: = Rapid Rejector A g to2e000 z 8 E 00000:
Slide 19: 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 20: Questions? Special Thanks
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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