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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	
  
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	
  
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	
  
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	
  
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	
  
•  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	
  
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
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
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
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
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
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	
  	
  
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	
  
Confiden'al	
  -­‐	
  not	
  for	
  distribu'on	
   14	
  
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	
  
 
	
  
Confiden'al	
  -­‐	
  not	
  for	
  distribu'on	
  
Howard	
  Scher	
  MD,	
  Head	
  	
  of	
  Clinical	
  Consor6um	
  	
  
16	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  

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03 avth

  • 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. 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. 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. 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. The  Problem  -­‐  Prostate  Cancer     High  Incidence     •  Prostate  Cancer  is   the  most  common   type  of  cancer  in   men  in  the  USA   •  Annual   expenditures   exceed  $15  billion   Limited  efficacy  for   metasta'c  disease   •  Radia'on,   hormonal  and   chemotherapy   remain  pallia've   High  Toxicity   •  Severe  bone   marrow  toxicity   and  poor   tolerance   Confiden'al  -­‐  not  for  distribu'on   Effective    drug  based  therapy  and  immunotherapy   is  an  unmet  clinical  need  in  prostate  cancer     5  
  • 6. •  Low amount of drug, high efficacy •  Low blood and bone marrow toxicity •  Over 6 million dollars invested in development (pre-AVT) •  Capridines and 200 of their derivatives are patent protected for use as anticancer agents in US, EU, Mexico, Canada, Israel The  Solu6on:  Capridine-­‐β  (C-­‐1748)   NCI  tested   prostate   cancer   specific  drug   Limited  side   affects   High   therapeu'c   index  for   prostate   Patent-­‐ protected   Confiden'al  -­‐  not  for  distribu'on   6  
  • 7. Prostate cancer cells (DU-145) are ten to 100 fold more sensitive to Capridine-β than leukemic cells (HL-6O) 1   2   Capridine-β Kills Prostate Cancer Preferentially Confiden'al  -­‐  not  for  distribu'on   DU-145 Cells Treated with Capridine-β HL-60 Cells Treated with Capridine-β
  • 8. Capridine-­‐β    is  a  Potent  An6cancer  Drug   in  Several  Cancers     0" 10" 20" 30" 40" 50" 60" Uterus" Leuk" Breast" Colon" lymph" Sarc" Prostate" Mul$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. 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. 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. 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. 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. 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. Confiden'al  -­‐  not  for  distribu'on   14  
  • 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.     Confiden'al  -­‐  not  for  distribu'on   Howard  Scher  MD,  Head    of  Clinical  Consor6um     16  
  • 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. 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. 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. 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. 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. 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