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Safe Harbor

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Cellular vs. Humoral. Therapeutic drugs. For TREATMENT. of disease. Only drugs in development ... HUMORAL IMMUNITY. The Immune System. 10. HspE7: CoVal HPV ... – PowerPoint PPT presentation

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Title: Safe Harbor


1
(No Transcript)
2
Safe Harbor
  • This presentation contains forward-looking
    statements that involve risk and uncertainties. 
    All statements, other than statements of
    historical fact, are forward-looking statements,
    including, without limitation, statements
    regarding future financial position, business
    strategy, proposed acquisitions, budgets,
    research and development costs and plans, future
    sales and market size, and objectives of
    management for future operations.  You can
    identify many of these statements by looking for
    words such as believe, expects, will,
    intends, projects, anticipates,
    estimates, continues or similar words or the
    negative thereof.  The predictions described in
    these statements may not materialize if
    managements current expectations regarding our
    future performance or events prove incorrect. 
    Actual results could be materially different from
    those predicted or implied by these forward
    looking statements due to factors over which we
    have limited control including, but not limited
    to, our ability to continue as a going concern,
    our ability to enter into corporate partnering
    relationships (and the effects and terms of those
    relationships), our ability to raise additional
    funds, the outcomes from clinical trials, our
    ability to meet regulatory approval requirements,
    difficulties inherent in the manufacture of
    commercial grade drug supplies, the risk that
    even if successfully developed, our products may
    not be commercially successful and other risks
    described in our annual information form for the
    year ended December 31, 2005 under the heading
    Risk Factors.  Our forward-looking statements
    are based on currently available information. We
    assume no obligation and expressly disclaim any
    duty to update any forward-looking statement to
    reflect events or circumstances after the date of
    this presentation or to reflect the occurrence of
    subsequent events. 

3
Nventa The Opportunity
  • Huge unmet medical need for HPV therapies
  • 20 million Americans have contracted the virus
  • New awareness with Merck vaccine not a
    therapeutic
  • Exciting 2nd generation compound for the
    therapeutic treatment of HPV-HspE7
  • Experience in over 400 patients (1st generation)
  • 10-fold potency over 1st generation
  • Opportunity to advance quickly into late stage
    trials in multiple HPV related indications
  • CIN, RRP, GW
  • cGMP manufacturing process for HspE7 in place and
    validated
  • Core HspE7 (CoVal) technology platform has
    potential for expanded indications beyond HPV

4
Leadership
5
Lead Product Candidate
6
The Problem
  • HPV (Human Papillomavirus)
  • 20 million American men and women currently
    infected and 5.5 million new cases diagnosed
    each year
  • Cause of three broad categories of disease
    benign lessions, pre-cursors to cancer and cancer
  • Second most costly STD after HIV infection
  • Few effective treatments surgery or topical
    ointment (for genital warts)

Tremendous need for therapeutic drug targeting
HPV that will decrease or eliminate the need for
surgery
7
The Opportunity Premium Price Strategy
8
The Solution HspE7
9
The Immune System
CELLULAR IMMUNITY
HUMORAL IMMUNITY
  • Prophylactic vaccines
  • For PREVENTION of disease
  • Marketed products
  • Polio, MMR, Influenza, Hep B
  • Merck/Glaxo HPV vaccines
  • Antibody response
  • Destroy pathogens outside of cells
  • Therapeutic drugs
  • For TREATMENT of disease
  • Only drugs in development
  • T and/or B-Cell mediated response
  • Destroy cells already infected with disease

Cellular vs. Humoral
10
HspE7 CoVal HPV Fusion Product
  • Heat shock protein (Hsp)
  • Full length M. bovis BCG Hsp65 (539 aa)
  • Viral Antigen
  • Full length HPV Type 16 E7 Protein (98 aa)

E7
Hsp65
Immune System Antigen Presentation
HPV Antigen Specificity
11
h
Mechanism of Action
HspE7 binds to Hsp receptors on dendritic cell
Dosing sub-q x3 Day 0, 30, 60
Hsp
E7
Killer T cell is programmed to recognize HPV
infected cells containing E7
HspE7 is engulfed and portions of E7 appear on
surface of dendritic cells
HPV infected cells are destroyed by E7 specific
killer T cells
12
Intellectual Property
  • Composition of Matter
  • Core Technology (Hsp fusion) Patents (MIT
    exclusive license)
  • Two U.S. patents to expire 2019
  • One European patent to expire 2014
  • Hsp fusions with HPV viral antigens
  • One U.S. patent for HspE7 and additional HPV
    fusions to expire 2018
  • One European patent for HspE7 and additional HPV
    fusions to expire 2018
  • Additional patents being filed on new formulation
  • Hsp fusions targeting hepatitis B
  • Hsp fusions targeting influenza
  • Method-of-use
  • U.S. patent for use of HspE7 for RRP to expire
    2021
  • Two EU HspE7 use patents
  • Manufacturing
  • Composition of matter patents include claims
    covering core manufacturing steps

13
Strengthened Intellectual Property
  • June 2006 Granted two additional E.U. patents
    covering use of HspE7
  • May 2006 Granted E.U. patent covering
    therapeutic fusion product to treat influenza
  • Sept 2005 Granted U.S. patent covering
    therapeutic fusion products to treat Hepatitis B
  • July 2005 Granted U.S. patent covering HspE7
    manufacturing
  • Oct 2005 Received favorable response from
    European Patent Office on Antigenics patent
    challenge
  • Maintains critical key composition-of-matter
    patent on lead compound HspE7
  • Validates patent strategy
  • Provides key competitive advantage over
    competitors

Filing new patents on 2nd generation products
14
Clinical History
15
HspE7 Historical Data
  • Preclinical Data
  • Curative in preclinical tumor model (TC-1)
  • Demonstrated significant activity in two other
    potency models
  • Clinical Data
  • Pilot-grade HspE7 drug completed multiple Phase 2
    clinical studies in over 400 patients
  • Cervical Intraepithelial Neoplasia (CIN) 2x
    Phase 2 trials
  • Recurrent Respiratory Papillomatosis (RRP) Phase
    2
  • Genital Warts 2x Phase 2
  • Anal Intraepithelial Neoplasia (AIN) 2x Phase 2,
    1 Phase 3 (non-pivotal)
  • Strong body of consistent positive results in
    four different HPV indications
  • Favorable side effect profile

16
Preclinical HPV Model TC-1
TC-1 tumor cells
Tumor palpation
C57Bl/6 mouse
HspE7 treatment
Day 0
Day 7
Day 10, 17, 24, 31, 38, 45
17
HspE7 Potency
Could not maintain potency with commercial process
18
Preclinical Development HspE7 Follow-on Product
19
Adjuvant Poly-ICLCpolyriboinosinic acid
polyribocytidylic acid poly-lysine CMC
polyIC poly-Lysine
Carboxymethylcellulose
polyIC immunologically active
compound Poly-Lysine stabilizer
protector CMC solubilizer
20
HspE7 Follow-on Product Key Preclinical Data
21
Clinical Strategy
22
HspE7 Development Pathway
Phase 1 Patients with Cervical Dysplasia
Primary Path
Additional Path
Additional Path
Genital Warts Phase 2
RRP Pivotal
Cervical Dysplasia Phase 2
23
Phase 1 Cervical Dysplasia
24
Cervical Dysplasia Phase 2
  • Double blinded, two arm, 21 randomization
  • Placebo
  • New HspE7 (HspE7 adjuvant)
  • Primary Endpoint downgrade in cervical dysplasia
    to CIN 1 or no dysplasia
  • N 300 powered _at_ 90 to detect a plt0.05 with
    95 confidence interval
  • Estimated drug response rate 40, estimated
    placebo rate 25
  • Principal Institutions USC, MD Anderson
  • Estimated Start Date 2H2007
  • Overall Timeline 1 year
  • Start Q407
  • 6 months for enrollment
  • 6 months to endpoint
  • Data base lock Q408

25
RRP Pivotal Trial
  • Similar to design previously reviewed by FDA
    under Special Protocol Assessment (SPA)
  • Patient Population RRP
  • Double blinded, placebo controlled
  • Primary Endpoint median post-surgical interval
  • N 200 powered _at_ 80, to detect a plt0.05 with
    95 confidence interval
  • Estimated Timeline
  • 6 months for enrollment
  • 12 months to endpoint
  • 1 month data base lock

26
Genital Warts Phase 2
  • Double blinded, two arm
  • Placebo
  • New HspE7 (HspE7 adjuvant)
  • Primary Endpoint Complete clearance or decrease
    in lesion size
  • 300 subjects, randomized. Powered _at_ 80 to detect
    a plt0.05 with 95 confidence interval
  • Estimated drug response rate 50, estimated
    placebo rate 30
  • Estimated Start Date 2H2007
  • Estimated Timeline
  • 6 months for enrollment
  • 6 months to endpoint
  • 1 month data base lock

27
24 Month Major Milestones
  • Follow-on HspE7
  • File IND with FDA Q406
  • Submit protocol to IRBs Q406
  • Dose first patient in Phase 1 trial 1H2007
  • Dose first patient in cervical dysplasia Phase 2
    trial Q407
  • Lock data base and announce cervical dysplasia
    Phase 2 data Q408
  • Gain funding for influenza program complete IND
    enabling studies
  • Explore pipeline expansion through MA

28
Nventa The Opportunity
  • Huge unmet medical need for HPV therapies
  • 20 million Americans have contracted the virus
  • New awareness with Merck vaccine not a
    therapeutic
  • Exciting 2nd generation compound for the
    therapeutic treatment of HPV-HspE7
  • Experience in over 400 patients (1st generation)
  • 10-fold potency over 1st generation
  • Opportunity to advance quickly into late stage
    trials in multiple HPV related indications
  • CIN, RRP, GW
  • cGMP manufacturing process for HspE7 in place and
    validated
  • Core HspE7 (CoVal) technology platform has
    potential for expanded indications beyond HPV

29
Nventa The Opportunity
20mm 2 Years Phase 2 Data
30
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31
HspE7 Historical Clinical Trial Data
32
HspE7 Historical Clinical Trial Data
33
HspE7 Historical Clinical Trial Data
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