03 avth


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03 avth

  1. 1. AV  THERAPEUTICS   Investor  presenta6on   Confiden'al  -­‐  not  for  distribu'on   Except  for  historical  information,  the  statements  made  in  this  presentation  are  forward     looking  statements  involving  significant  risks  and  uncertainties.   “Be9er  Treatment  of  Cancer  through  Innova6on”   A  New  York  Based  Biotechnology  Company   1  
  2. 2. AV  Therapeu6cs:    Developing  Safer  and  More   Effec6ve  Chemotherapeu6c  Agents   Capridine:   -­‐Patented  drug     -­‐Specific  ac'vity   against  prostate   cancer  plus  an   immuno-­‐ therapeu'c   vaccine     Preliminary   efficacy  on  range   of  cancers   World-­‐class   team  of   physicians  and   clinical   researchers   Confiden'al  -­‐  not  for  distribu'on   2  
  3. 3. Capridine-­‐β  (C-­‐1748)   Confiden'al  -­‐  not  for  distribu'on   Deriva6ve   R1   R2   R3   R4   C-­‐1748   H   (CH2)2OH   CH3   H   Data  on  file  AV  Therapeu6cs,  Inc.   3  
  4. 4. Management  Team   Abraham   Mi9elman  ,   M.D.,  Chief   Execu6ve  Officer   and  Chairman  of   the  Board   • Oncologist  and   Associate  Prof.  at   New  York   Medical  College   (NYMC)  with   over  30  years  of   experience  in   pa'ent   treatment  and   clinical  trials.       Raj  Tiwari,  Ph.D.,   Chief  Scien6fic   Officer   • Professor  of   Microbiology  &   Immunology  and   Graduate   Program  Director   at  NYMC  with   over    30  years  of     Cancer  Research,   inventor  of  AVTs   IPs  related  to   Capridine  and   Pep'de    Vaccine   Technology.   Morton   Coleman,  M.D.,   Vice  President,   Director  of   Clinical   Development     • Clinical  Professor  at   Weill  Medical   College,  Cornell   University,  Director   of  the  Center  for   Lymphoma  and   Myeloma  at  New   York  Presbyterian   Hospital       Robert  Pollock,   President   • Over  40  years   business   experience.   Founder  and   managing   partner  of   Con'nuum   Partners,  a  global   network  security   and  business   development   consul'ng  firm.   Jan  Geliebter,   Ph.D.,  Secretary,   VP  Genomic   Plaborms   • Professor  of   Microbiology  &   Immunology  at   NYMC  with  over   30    years  of   Cancer  Research   experience   Holder  of   mul'ple  patents,   including  AVTs  IP     BCG-­‐based   prostate  cancer   vaccine   Debabrata   Banerjee,  Ph.D.,   VP  Preclinical   Development   • Associate  Professor   of  Medicine  and     Pharmacology,   Rutgers  University   with  Over  30  years   of  experience  in   preclinical  and   exptal  therapeu'cs     and  Inventor  of   several  patents.   Confiden'al  -­‐  not  for  distribu'on   4  
  5. 5. The  Problem  -­‐  Prostate  Cancer     High  Incidence     •  Prostate  Cancer  is   the  most  common   type  of  cancer  in   men  in  the  USA   •  Annual   expenditures   exceed  $15  billion   Limited  efficacy  for   metasta'c  disease   •  Radia'on,   hormonal  and   chemotherapy   remain  pallia've   High  Toxicity   •  Severe  bone   marrow  toxicity   and  poor   tolerance   Confiden'al  -­‐  not  for  distribu'on   Effective    drug  based  therapy  and  immunotherapy   is  an  unmet  clinical  need  in  prostate  cancer     5  
  6. 6. •  Low amount of drug, high efficacy •  Low blood and bone marrow toxicity •  Over 6 million dollars invested in development (pre-AVT) •  Capridines and 200 of their derivatives are patent protected for use as anticancer agents in US, EU, Mexico, Canada, Israel The  Solu6on:  Capridine-­‐β  (C-­‐1748)   NCI  tested   prostate   cancer   specific  drug   Limited  side   affects   High   therapeu'c   index  for   prostate   Patent-­‐ protected   Confiden'al  -­‐  not  for  distribu'on   6  
  7. 7. Prostate cancer cells (DU-145) are ten to 100 fold more sensitive to Capridine-β than leukemic cells (HL-6O) 1   2   Capridine-β Kills Prostate Cancer Preferentially Confiden'al  -­‐  not  for  distribu'on   DU-145 Cells Treated with Capridine-β HL-60 Cells Treated with Capridine-β
  8. 8. Capridine-­‐β    is  a  Potent  An6cancer  Drug   in  Several  Cancers     0" 10" 20" 30" 40" 50" 60" Uterus" Leuk" Breast" Colon" lymph" Sarc" Prostate" Mul$ples(of(effec$veness(of( (CAP((compared(to(MITX( Cap"" MITX" Confiden'al  -­‐  not  for  distribu'on   Comparisons between the two drugs are based on IC50 values IC50 is the drug concentration required to kill 50% cells 8   * *Mitoxantrane
  9. 9. Treatment started week 1, once weekly for 7 – 9 weeks 1   3   2   Capridine - β Inhibits Hormone-Responsive and Non-Responsive Xenografts in Nude Mice 9  Confiden'al  -­‐  not  for  distribu'on   4
  10. 10. Loss  of  Androgen  Receptor  Early  Step  in   Prostate  Tumor  Progression   Hormone Dependent Confiden'al  -­‐  not  for  distribu'on   10   Hormone Independent Loss of Androgen Receptor Upregulation of ER-β Upregulation of CDC25 group
  11. 11. 6 h 12 h C 5 nM 10 nM 5 nM 10 nM Actin Androgen receptor Capridine-­‐β  renders  Hormone-­‐Independent   DU-­‐145  CaP  Cells  Hormone  sensi6ve     Confiden'al  -­‐  not  for  distribu'on   11   0   0.5   1   1.5   Control   5nm  (6hr)   10nm  (6hr)   5nm  (12hr)   10nm  (12hr)   Induction of Androgen Receptor in DU-145 Cells RelativeDensity
  12. 12. Cell  lines   IC50  Values  (nM)     Taxane                                                      Capridine   LnCaP   >100nM   15nM   PC3   16-­‐20nM   5nM   DU145   15-­‐20nM   5nM   Confiden'al  -­‐  not  for  distribu'on   12   Capridine  is  superior  to  taxane  and  is  effec've  on  taxane  resistant  prostate  cancer    
  13. 13. Salient  Features  of  Capridine-­‐β   Capridine-­‐β  is  ac've   against  taxane   resistant  prostate   cancer  cells   Capridine-­‐β  does   not  kill  bone   marrow  cells  or   white  blood  cells   Capridine-­‐β  has  a   wide  predicted   human  therapeu'c   dose  range     Capridine-­‐  β  is   ac've  on  hormone   dependent  and   independent   Prostate  cancer   (CaP)  xenografs   Confiden'al  -­‐  not  for  distribu'on   13  
  14. 14. Confiden'al  -­‐  not  for  distribu'on   14  
  15. 15. Development  Plan  for  Capridine β –  Next  Steps   Drug   manufacture   and  formula'on   under  GMP   condi'ons   Stability   tes'ng  of  the   formulated   product   Limited  rodent   and  dog   toxicology  with   formulated   product   Pharmacokine'cs  and   pharmacodynamics   IND   applica'on   Phase  I/II   clinical   trials   Confiden'al  -­‐  not  for  distribu'on   15  
  16. 16.     Confiden'al  -­‐  not  for  distribu'on   Howard  Scher  MD,  Head    of  Clinical  Consor6um     16  
  17. 17. Scien6fic  Advisory  Board   •    Joseph  Ber6no,  MD,  Associate  Director  and  Chief  Scien'fic  Officer,  The  Cancer  Ins'tute  of   New  Jersey  and  past  President  of  the  American  Associa'on  for  Cancer  Research  and  The  American   Associa'on  of  Clinical  Oncologists,  organiza'ons  of  over  50,000  researchers,  worldwide.  He  is  the   founding  Editor  of  the  Journal  of  Clinical  Oncology.     •    Charles  Cantor,  PhD,  is  Director  of  the  Center  for  Advanced  Biotechnology  at  Boston   University  and  Chief  Scien'fic  Officer  at  Sequenom,  Inc.  in  La  Jolla  (a  publicly  traded  company).  He   has  published  more  than  400  ar'cles,  and  has  been  awarded  more  than  sixty  (60)  patents.  He  is   most  known  for  his  authoring  of  the  book,  Genomics:  The  Science  and  Technology  Behind  the   Human  Genome  Project.       •    Roy  G.  Smith,  PhD,  is  the  Director  of  then  Huffington  Center  on  Aging,  Professor  in  the   Department  of  Molecular  and  Cellular  Biology,  and  Professor  in  the  Department  of  Medicine  at   Baylor  College  of  Medicine.  He  was  previously  Vice  President  of  Basic  Research  at  Merck  and  was   responsible  for  iden'fying  new  drug  targets  for  metabolic  diseases       •    Pramod  Srivastava,  PhD,  is  a  Professor  of  immunology  at  the  University  of  Connec'cut,   where  he  holds  an  Endowed  Chair  in  Cancer  Immunology  and  is  the  Director  of  the  Cancer  Center   and  the  Scien'fic  Founder  of  An'genics.  He  is  among  the  founding  members  of  the  Academy  of   Cancer  Immunology.     Confiden'al  -­‐  not  for  distribu'on   17  
  18. 18. Use  of  proceeds  for  development  of  Capridine   Confiden6al  -­‐  not  for  distribu6on   Clinical   product   synthesis   and  testing   IND  application  &   FDA  approval  for   Phase  I   Initiation  and   completion   of  Phase  I   Overall   development       Cost  ($000)   Activities   •   GMP  synthesis   • Stability   • Toxicology   • Formulation   •  Contractual  services  for  IND   •  Data  analysis  and  compilation   •  Chem  manufacture  write  up   •  Comp  lab  mechanism  studies   •   Multicenter  Phase  I   •     Consortium  lead   • 60  patients   •     Clinical  development  of  Capridine     Output   •   Capridine  IND   •   Approval  for  Phase  I   •   Phase  I/  II  trial   •  Licensing  of  Capridine  to     strategic  partner   •  Continue  development   1,000   500   1,500   $3  million      months  0-­‐6   Months  6-­‐12    months  12-­‐18   Strategy    Output   Output   Output   Activities     Activities     18  
  19. 19. Summary   •  Preclinical  studies  complete  for  Capridine.    Unique  proper'es  include  no   blood  toxicity  and  wide  therapeu6c  dose  range  with  specificity  towards   prostate  cancer  -­‐  ready  to  commence  phase  I  and  II  human  trials         •  A  world-­‐class,  interna'onally  recognized,  well  published  scien'sts  and   clinicians  (PhD’s  and  MDs)  from  A+  ins'tu'ons     •  World  class  medical  research  collaborators  and  Scien'fic  Advisory  Board   •  All  IP  is  patent  protected     Confiden'al  -­‐  not  for  distribu'on   19  
  20. 20. Pros-­‐Vax  Pep6de  Therapeu6c  Vaccine     •  Synthe'c   pep'de   vaccine   (Pros-­‐Vax)   that   mimics   cancer   proteins,  induces  the  host’s  immune  response  directed  against   mul'ple  cancer-­‐specific  proteins   •  Easily  manufactured,  small  molecule  drug   •  Preclinical  studies  complete   •  Expected  to  eliminate  micrometasa'c  and  residual     disease  and  hence  prevent  recurrence     Confiden'al  -­‐  not  for  distribu'on   20  
  21. 21. Immunization  with  peptide  vaccines  prevents   metastatic  prostate  cancer  growth     Unimmunized  rat   Immunized  rats     BTE6-­‐LX-­‐8b   ProVac  1   BTE6-­‐X-­‐15-­‐7   ProVac  2   Confiden'al  -­‐  not  for  distribu'on   21  
  22. 22. Current  Capital  Structure   •  Authorized  Common  shares                                                                  :  200,000,000   •  Outstanding  AVT  principals  and  prior  investors:      58,000,000       •  Barry  Honig  and  PubCo  Group  investors                      :      17,000,000     •  Proposed    $3.5  million  raise  by  PPM  @  $0.20/share  and  a   warrant  to  purchase  one  half  of  a  share  of  the  Company’s   common  stock             Confiden'al  -­‐  not  for  distribu'on   22