Avth investor presentationredchip-13

AV THERAPEUTICS
A New York Based Biotechnology Company

Investor presentation
“Treatment and Prevention of Prostate Cancer through Innovation”

Except for historical information, the statements made in this presentation are forward
looking statements involving significant risks and uncertainties.

Confidential - not for distribution

1

Safe Harbor Statement
All statements pertaining to future financial and/or operating results, future growth in research,
technology, clinical development, and potential opportunities for AV Therapeutics, Inc. (The Company)
products and services, along with other statements about the future expectations, beliefs, goals, plans,
or prospects expressed by management constitute forward-looking statements.
Any statements that are not historical fact (including, but not limited, to statements that contain words
such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be
forward-looking statements.
Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent
in the development and/or commercialization of potential products, uncertainty in the results of clinical
trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual
property rights and other risks discussed in the Company’s registration statement on Form S-1 and
other reports filed with the Securities and Exchange Commission which is available for review at
www.sec.gov.
Actual results may differ materially from the results anticipated in these forward-looking statements
and as such should be evaluated together with the many uncertainties that affect the Company's
business.
The Company disclaims any intent or obligation to update these forward-looking statements.


2

AV Therapeutics
• Corporate Headquarters
20 East 68th Street
New York, NY 10065
Suite 204

• Research Facilities
New York Medical College
Cancer Institute of New Jersey

3

AV Therapeutics - Overview
• AVT is a Biotechnology company focused on:
• Targeted drug based cancer therapies that are safer and
more effective than current chemotherapeutic agents
• Proprietary peptide based immunotherapeutic vaccine
technology platform

• Scientists at AVT have developed Capridine:
• A patented drug having specific activity against prostate
cancer

• Outstanding physicians and clinical researchers

4

Management Team
•

Abraham Mittelman , M.D., Chief Executive Officer and Chairman of the
Board
Oncologist and professor at New York Medical College (NYMC) with over 30 years of experience in patient treatment and clinical trials.
Over 200 peer reviewed publications and presentations, trained at Memorial Sloan Kettering Cancer Center (Memorial).

•

Raj Tiwari, Ph.D., Chief Scientific Officer
Professor of Microbiology & Immunology and Graduate Program Director at NYMC. Over 30 years of research experience with over 150
peer reviewed publications and presentations. Trained at Memorial, inventor of several patents involving Capridine and Peptide based
Cancer Vaccine Technology.

•

Morton Coleman, M.D., Vice President, Director of Clinical Development
Clinical Professor at Weill Medical College of Cornell University and Director of the Center for Lymphoma and Myeloma at New York
Presbyterian Hospital – Weill Cornell. Chairman, Medical Affiliate Board of Lymphoma Research Foundation, over 400 publications and
designated one of the “Best Doctors in America”

•

Robert Pollock, President
Over 40 years business experience. Founder and managing partner of Continuum Partners, a global network security and business
development consulting firm.

•

Jan Geliebter, Ph.D., Secretary, VP Genomic Platforms
Professor of Microbiology & Immunology at NYMC with over 30 years of cancer research experience and over 100 peer reviewed
publications. Holder of multiple patents, including a BCG-based prostate cancer vaccine

•

Debabrata Banerjee, Ph.D., VP Preclinical Development
Associate Professor of Medicine and Pharmacology, The Cancer Institute of New Jersey. Over 25 years of experience in preclinical and
experimental therapeutics with over 125 publications and presentations. Inventor of several patents.


5

The Problem - Prostate Cancer
• Prostate Cancer is the most common type of cancer in men in
the USA
• Annual expenditures exceed $15 billion
• Current therapies have limited efficacy for metastatic disease
• Current chemotherapeutic regimens are associated with
severe bone marrow toxicity and poor tolerance
• Current immunotherapy (Provenge) is expensive and has
minimal efficacy
• Radiation, hormonal and chemotherapy remain palliative
Effective drug based therapy and immunotherapy
is an unmet clinical need in prostate cancer

6


7

The Solution - Capridine
• Identified a new class of patent protected nitro-acridine drugs
known as Capridines that has specific targeted activity
towards prostate, colon and other cancers
– Dr. Raj Tiwari and Dr. Jerzy Konopa from Gdansk, Poland are coinventors
– Patents are for composition and use and sub-licensed to AVT
– Protected in
•
•
•
•
•

USA
EU
Mexico
Canada
Israel


8

Capridine-β (C-1748)
• Capridines and 200 of their derivatives are patent protected
for use as anticancer agents
• US patent on combination of capridines with other agents
• NCI tested prostate cancer specific drug
• Over 6 million dollars invested in development (pre-AVT)
• Limited side affects
– Low blood and bone marrow toxicity

• High therapeutic index for prostate
– Low amount of drug, high efficacy

Data on file AV Therapeutics, Inc.


9

Capridine-β (C-1748)

Derivative

R1

R2

R3

R4

C-1748

H

(CH2)2OH

CH3

H



10

Capridine-b has Differential IC50 Values in
CaP and Leukemic Cells
1

2

Prostate cancer cells are ten to 100 fold more sensitive to capridine-b than leukemic cells
(HL-6O)


11

Capridine-β is a more potent anticancer drug
than Mitoxantrone in several cancers



12

Capridine - b Inhibits Hormone-Responsive and Non-Responsive CaP
Xenografts in Nude Mice
4
3

6

5

Treatment started week 1, once weekly for 7 – 9 weeks


13

Cell lines

IC50 Values (nM)
Taxane

Capridine

LnCaP

>100nM

15nM

PC3

16-20nM

5nM

DU145

15-20nM

5nM


14

80

cross-linked [%]

60

HeLa S3
LnCaP
CEM
HT-29

40

20

0

0.01

0.1

1

10

Drug concentration [ mM]

100

DNA cross-linking induced by Capridine b in different
tumor cells incubated with compounds for 14 h

15

Prostate cancer

Hormone dependant

1.
2.
3.

Hormone
independent

Loss of androgen receptor
Upregulation of ER-β
Upregulation of CDC25 group of proteins

16

Capridine-β induces the androgen receptor in hormone
independent DU-145 cells
C

6h
5 nM 10 nM

12 h
5 nM 10 nM

Actin

Androgen receptor

Series1


17

Salient Features of Capridine-β
• Capridine- β is active on hormone dependent and
independent Prostate cancer (CaP) xenografts
• Anti cancer doses of Capridine-β in animals and MTD values in
dogs (1.84mg/Kg) extrapolated to humans has a wide human
therapeutic dose range
• Specificity towards CaP and high differential IC50 values for
hematopoietic cells making Capridine-β a non-myelosuppressive chemotherapeutic agent



18

Salient Features of Capridine-β
• Capridine-β is active against taxane resistant prostate cancer
cells, hormone dependent and hormone independent
prostate cancer xenografts and is non-myelosuppressive
• Capridine- β renders aggressive hormone independent CaP
cells hormone sensitive and thus can synergize with antiandrogen therapy in Cap

• The cell cycle kinase cdk-4 and the tumor suppressor gene
p16 are the specific targets of capridine-β in prostate cancer



19

Capridine


20

Capridine-β Advantage
• Based on the results of Pre-Clinical Studies,
Capridine-β has minimal bone marrow toxicity
with a wide therapeutic range active against
taxane resistant CaP cells
• Capridine-β can be added to other drugs thus
lowering chemotherapy associated toxicities



21

Development Plan for Capridine – Next Steps
• Drug manufacture and formulation under GMP conditions
• Stability testing of the formulated product

• Limited rodent and dog toxicology with formulated product
• Pharmacokinetics and pharmacodynamics

• IND application
• Phase I/II clinical trials

22

Pros-Vax Peptide Therapeutic Vaccine
• Synthetic peptide vaccine (Pros-Vax) that mimics cancer
proteins, induces the host’s immune response directed against
multiple cancer-specific proteins

• Easily manufactured, small molecule drug
• Preclinical studies complete
• Expected to eliminate micrometasatic
disease and hence prevent recurrence


and

residual

23

Immunization with peptide vaccines prevents
metastatic prostate cancer growth
Unimmunized rat

Immunized rats

BTE6-LX-8b
ProVac 1

BTE6-X-15-7
ProVac 2


24

Peptide
vaccine

Capridine


25

Scientific Advisory Board
•

Joseph Bertino, MD, Associate Director and Chief Scientific Officer, The Cancer Institute of
New Jersey and past President of the American Association for Cancer Research and The American
Association of Clinical Oncologists, organizations 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 Scientific Officer at Sequenom, Inc. in La Jolla (a publicly traded company). He
has published more than 400 articles, 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 identifying new drug targets for metabolic diseases

•

Pramod Srivastava, PhD, is a Professor of immunology at the University of Connecticut,
where he holds an Endowed Chair in Cancer Immunology and is the Director of the Cancer Center
and the Scientific Founder of Antigenics. He is among the founding members of the Academy of
Cancer Immunology.

26

Medical Advisors/Collaborators
• Dan Petrylak, M.D. - Director of the Prostate Cancer Program, Yale
University
• Ashutosh Tewari, M.D., - Director of the Prostate Cancer Institute and the
LeFrak Robotic Surgery Center at Weil Cornell Medical College [Tentative]
• Derek Raghavan, M.D. – President of the Levine Cancer Institute at the
Carolinas Healthcare System, formerly, Chairman and Director of the
Taussig Cancer Center at the Cleveland Clinic
• Christopher Logothetis, M.D. – Department Chair, Department of
Genitourinary Medical Oncology, Division of Cancer Medicine, The
University of Texas MD Anderson Cancer Center

27

Clinical Research Partner
The Prostate Cancer Clinical Trials Consortium
Howard Scher MD, Head of Clinical Consortium


28

Use of proceeds for development of Capridine
months 0-6

Months 6-12

Clinical
product
synthesis
and testing

IND application &
FDA approval for
Phase I

Activities
• GMP synthesis
•Stability
•Toxicology
•Formulation

Output
• Capridine IND

Activities
•
•
•
•

Contractual services for IND
Data analysis and compilation
Chem manufacture write up
Comp lab mechanism studies

Output
• Approval for Phase I

months 12-18

Initiation
and
completion
of Phase I

Overall
development

Activities

Output
• Multicenter Phase I
• Consortium lead
•60 patients

• Clinical development of Capridine

Output

Strategy
•

• Phase I/ II trial

•

Licensing of Capridine to
strategic partner
Continue development

Cost ($000)
2,500

1,000

1,600


5.1 million
29

Development of peptide vaccines for prostate cancer
Months 1-12
Peptide
vaccines for
prostate
cancer

Activities
• Peptide identification
• Tox testing
• Tech Assessment

Output
• therapeutic
Peptides ready
For clinical trial

Months 12-24

Peptide
vaccines

Activities
• Peptides human Pca
antigens
• Preclinical testing
•I

Output
• Limited Phase I/II trial

months 12-24
Pilot clinical
trial

Activities
• peptide synthesis
• IND submission

Output
• Phase I/ II trial

Cost ($000)
1,000,000


1,500,000

Marketing and
other strategies

1,500,000

Activities
•

Adjuvant development
•Acquisition of other
synergistic products
•cost of capital

Exit strategy

• Licensing of peptide
products to big pharma
• marketing
collaboration with
peptides and acquired
products
•Adjuvant marketing

4,000,000

30

Summary
• Preclinical studies complete for Capridine. Unique properties include no
blood toxicity and wide therapeutic dose range with specificity towards
prostate cancer - ready to commence phase I and II human trials
• A world-class, internationally recognized, well published scientists and
clinicians (PhD’s and MDs) from A+ institutions
• World class medical research collaborators and Scientific Advisory Board
• All IPs patent protected


31

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 2.5 m raise by PPM @ $0.20/share

: 12,500,000

• Proposed reverse merger with a PUBCO with Barry Honig as lead investor


32

Clinical Research Partner
The Prostate Cancer Clinical Trials Consortium
Howard I. Scher, MD, Head of Clinical Consortium
–
–
–





Memorial Sloan-Kettering Cancer Center
Chief, Genitourinary Oncology Service
D. Wayne Calloway Chair in Urologic Oncology
Education: MD Degree New York University School of Medicine
Fellowships: MSKCC, NY Hospital - Cornell Medical Center
Board Certifications: Internal Medicine, Medical Oncology
Clinical Expertise: Prostate Cancer, Genitourinary Malignancies,
Immunotherapy


33

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