Download Our focus is on vaccines

Akshaya Bio, Inc.
Chimigen® Technology
Re-educating Immune System
to Fight Diseases
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
1
Outline
 The Company
Management
Advisors & Consultants
R&D Team
 Chimigen® Platform Technology
 Product Pipeline & Status
 Issued Patents
 Akshaya’s Competitive Advantages
 Highlights
 Contact Information
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
2
Akshaya Bio Inc. – The Company
• Based in Edmonton, Alberta, Canada
– Currently a Team of Seven, Six Researchers (5 Ph.Ds, 1 B.Sc, 1 MBA)
– Privately held
• Founded in 2010
– Dendritic cell receptor-targeted vaccines
– Proprietary technology
• 23 Issued Patents
• 17 patents pending worldwide
– Acquired Chimigen® Technology from Paladin Labs Inc. (TSX) and
ViRexx Medical Corp. (TSX, AMEX)
• External Partners in Research and Development
– NRC-IRAP, CHTD, AITF, Gates Foundation
• Unique technology platform
•
Improved antigen presentation
–
–
“Mimics Body’s Own Natural Immune Response Process”
No adjuvant, avoids adverse reactions
• Rich product pipeline
–
HBV, HCV, HIV, Cancer, Malaria, Biodefense, Influenza, TB
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
3
Experienced Management
• Satish Chandran, Ph.D
CEO: biotech/vaccine veteran with 25+ years
leadership experience; ex Pfizer, Wyeth-Lederle
vaccines
• Rajan George, M.Sc, Ph.D
President and Chief Scientific Officer: 24+ years
R&D experience in virology, immunology, molecular
biology; ex Paladin Biosciences E.VP and CTO,
ViRexx Medical Corp. Senior VP
• Bruce Hirsche, QC
General & IP Counsel
• Rohit R. George, BA, MBA
Business Operations
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
4
Advisors & Consultants
Robert Gish, MD
Hepatologist, Clinical Director-Hepatitis B Foundation
Frank Chisari, MD
Scripps Institute
Natl. Acad. Member
Leading Expert in HBV and HCV
Timothy Block, Ph.D.
Director Inst. Hepatitis & Virus Res., Professor, Drexel U
President Hepatitis B Foundation
Richard Ascione, MD, Ph.D
Professor, Georgetown University, Washington DC
Fairlook Investment Advisors LLC, New York
Christopher Walker, Ph.D
Director, Center for Vaccines and Immunity, Nationwide
Children's Hospital, Columbus, Ohio
Expert in HCV immunotherapy
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
5
Research Team
• Allan Ma, Ph.D
• Senior Scientist, Virologist
• Dakun Wang, Ph.D
• Senior Scientist, Immunologist
• Gina Thede, Ph.D
• Biochemist/Molecular Biologist
• Hue Anh Luu, B.Sc
• Technologist
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
6
Chimigen® Platform Technology
A Novel Vaccine Technology
for Infectious Diseases and Cancer
Dendritic Cell Receptor-Targeted Vaccines
“Mimics Body’s Own
Natural Immune Response Process”
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
7
Chimigen® Platform Technology
•
Antigen – Xenotypic Antibody Fc-fusion
•
•
High immunogenicity
Targets APC receptors
•
Dendritic Cells (Fcγ, Lectin Receptors)
•
Generates Cellular & Humoral immune responses
•
Insect cell-based production
•
•
•
Imparts non-mammalian glycosylation
•
High immunogenicity
No added adjuvant
Dendritic Cell Receptor-Targeted Vaccines
•
Eliminates many adverse events
•
Eliminates T cell sequestration, dysfunction & deletion
Adaptable platform
•
HBV, HCV, HIV, Alphaviruses, Influenza, Malaria, TB, Cancer …
•
Potential use for both Prophylactic & Therapeutic Vaccines
•
Strong IP position: 23 issued patents, 17 pending applications
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
8
Akshaya Bio Inc.
Product Pipeline…..
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
9
Product Candidates & Status
Product
Discovery
Pre-Clinical
Phase I
Phase II
Chimigen® HBV Vaccine
Chronic Hepatitis B
Ready for licensing
Chimigen® HCV Vaccine
Hepatitis C
Ready for licensing
Chimigen® HIV Vaccine
HIV Prevention/
Therapy
Cancer Vaccines
Various Targets
Chimigen® Malaria
Vaccine
Malaria Prevention/
Therapy
Alphaviruses (WEEV)
Biodefense
Influenza
H5 & H1
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
Phase III
…..…………..Our focus is on vaccines
10
Akshaya Bio Inc.
HBV Therapeutic Vaccine:
Treatment for Chronic HBV Infection
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
11
Hepatitis B Virus (HBV) Infection
Shocking epidemiology:380 million chronic carriers
HBsAg Prevalence
>=8% - High
2-7% - Intermediate
<2% - Low
As many as 140 million people will die from HCC
or cirrhosis due to HBV without intervention
From Murray et. al., Medical Microbiology 5th edition, 2005, Chapter 66, published by Mosby Philadelphia
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
12
HBV Therapeutic Vaccine
Significant Unmet Need
• Considerations
• Over 380 million chronically infected (~2 million in US)
• One million deaths annually – Cirrhosis, Liver failure & HCC
•
Current Antiviral Therapies
• Polymerase Inhibitors
• Effective in 30-40% of chronically infected patients
• Mutant (resistant) strains appear frequently
6xHis
• Compliance issues with interferon treatment
•
•
CHO
IRD
CHO
Peptide Linker
Contains T & B cell-relevant HBV antigens
Able to elicit humoral and cellular response
Potential prophylactic and therapeutic uses
Ready to enter clinical studies
In discussions to out license
Accepted by NIH for Product Development Plan
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
HBV
S1/S2/Core
HBV
S1/S2/Core
Market: >$2B
Akshaya’s HBV Therapeutic Vaccine
•
•
•
•
•
•
6xHis
Portion of CH1
S-S
Hinge Region
S-S
SS
CHO
CH2 S S CCH2
H2
Xenotypic
Murine Fc
CHO
TBD
SS
SS
CH3
CH3
Peptide
…..…………..Our focus is on vaccines
13
Chimigen® HBV Therapeutic Vaccine
Efficacy, ex vivo
PBMCs derived from individuals
un-infected and with chronic HBV infection
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
14
Chimigen® HBV Therapeutic Vaccine
Summary
• Binds to immature DCs
– CD32 & CD206
• Appropriate antigen processing and presentation
– Efficacy in Normal and HBV carriers, ex vivo in DC/T cell antigen
presentation assays
• Induces activation and proliferation of CD8+ and CD4+ T cells
• Production of IFN-γ and TNF-α in CD8+ and CD4+ T cells
• Production of granzyme B in CD8+ & CD4+T cells
• Production of HBV antigen-specific CD8+ T cells (Pentamer
Positive)
• HBV peptide-specific T cell responses (IFN- and TNF- )
• Targeted cell killing
– HBV antigen-loaded Un-infected & HBV Chronic carrier cells
• Induces T(resp) cells, removes T(reg) cells
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
15
Chimigen® HBV Therapeutic Vaccine
Immunology, in vivo
Cellular and Humoral Responses in Sheep
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
16
Chimigen® HBV Therapeutic Vaccine
Results Summary, in vivo
• Chimigen® HBV Therapeutic Vaccine is immunogenic in sheep
• Chimigen® HBV Vaccine induced a dose-dependent antibody response
• Specificity for S1/S2 protein
• Significant response following the secondary immunization
• Kinetics of the antibody response similar to commercial HBV sAg vaccine
(Engerix-B, GSK), but with no added adjuvant
• Chimigen® HBV Vaccine induced a dose-dependent cell-mediated immune
response
• Specificity for S1/S2 protein
• Significant response following the secondary immunization
• Effective at low doses
• Systemic immune responses in blood was higher than the local immune
response in the lymph node draining the site of vaccination
• Induces immune activation in HBV-transgenic mice (NIH Study)
• HBV Vaccine is induces systemic cell-mediated immune response
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
17
Chimigen® HBV Core Therapeutic Vaccine
Immunology, in vivo
HBV Transgenic Mice
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
18
Chimigen® HBV Core Therapeutic Vaccine
Chimigen® HBV Core Therapeutic Vaccine in HBV Transgenic Mice
Induced Immune Responses in the Liver Following Intradermal Injections
Study Carried out by NIH Expt. No. NHA-77
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
19
Chimigen® HBV Vaccine
Therapeutic Value
•
Immune Responses are indicative of breaking
tolerance in HBV chronic carriers
•
These novel responses are indicative of administering
a therapeutic effect
– Production of new epitope-specific CTLs
– The Killing of HBV-infected target cells
– Production of T responder cells
– Killing of T regulatory cells by T responder cells
– Cytokine induction in HBV transgenic mice
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
20
Akshaya Bio Inc.
Chimigen® HCV Vaccine:
Prophylactic/Therapeutic Vaccine
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
21
Hepatitis C Virus (HCV) Infection
•
Considerations
•
HCV is a global health care problem (WHO)
• 3-4 million new infections each year
• 170 million chronically infected
• 2.7 million in US
• Cirrhosis and loss of liver function, HCC
•
6xHis
6xHis
HCV
E1-E2-NS5A
Current Therapies
HCV
E1-E2-NS5A
CHO
CHO
•
Antivirals, Interferon α, Polymerase and Protease inhibitors
IRD
Peptide Linker
Portion of CH1
• Effective in select viral strain infections and groups
S-S
Hinge Region
S-S
SS
• High costs
CHO
CH2 S S CCH2
H2
CHO
Xenotypic Fc
• Severe side effects with interferon treatment – compliance issues
TBD
SS
• Continued emergence of drug resistant mutants
SS
CH3
CH3
Peptide
Contains two B cell and one T-cell relevant HCV antigens
•
Akshaya’s HCV vaccine is designed for prophylactic and therapeutic applications
•
Design and process development completed
•
Preclinical studies completed
•
Ready for clinical development
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
22
Chimigen® HCV E1-E2-NS5A Vaccine
6xHis
6xHis
HCV
E1-E2-NS5A
HCV
E1-E2-NS5A
IRD
CHO
CHO
Peptide Linker
Portion of CH1
S-S
Hinge Region
S-S
SS
CHO
CH2
SS
CHO
CCH2
H2
Xenotypic Fc
TBD
SS
SS
CH3
CH3
Peptide
HCV Prophylactic/Therapeutic Vaccine
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
23
Chimigen® HCV E1-E2-NS5A Vaccine
Summary
• Purified and characterized
• High Yield ~20mg/Litre
• Binds to immature Dendritic Cells
• Vaccine-loaded DCs HCV naïve individuals induce:
•Proliferation of CD8+ and CD4+ T cells
•Increase in the proportion of CD8+ and CD4+ T cells
producing the Th1 cytokines IFN-γ and TNF-α
•Proliferation of CD19+CD138+ B cells
•Proliferation of CD19+CD38+ B cells
• Induces both T cell and B cell immune responses
• Excellent potential to develop Prophylactic/Therapeutic
Vaccine
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
24
Chimigen® HIV Vaccine
6xHis
6xHis
HIV antigens
HIV antigens
Gag/Env/Tat/Rev/Vpr/Vpu
Gag/Env/Tat/Rev/Vpr/Vpu
CHO
IRD
CHO
Peptide Linker
Portion of CH1
Hinge Region
S-S
S-S
S S
Xenotypic
(Murine)Fc
CHO
CHO
CH2 S S CCH2
H2
TBD
S S
CH3
S S
CH3
Multiple HIV Antigen Targets
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
25
Chimigen® HIV Vaccine
Immune Responses, ex vivo
• Binding to Dendritic Cells
• Dendritic Cell / T Cell Antigen Presentation Assay (APA) ex vivo
Human Peripheral Blood Mononuclear Cells (PBMCs)
• T cell immune responses
• T cell proliferation (CFSE staining)
• Th1 cytokine production (IFN-, TNF-)
• CTL activity CD8+ T cells
• Granzyme B & Perforin production
• T cell antigen-specificity responses
• Peptide pools (Env, Gag: accessory proteins)
• B Cell Differentiation Assay
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
26
Chimigen® HIV Vaccine: Summary
• Chimigen® HIV Multi-antigen Vaccine was designed & cloned
• Prophylactic/Therapeutic applications
• Vaccine
• Produced in Sf9 insect cells & purified
• Immune response ex vivo, using human DC/T cells
• Chimigen® HIV Vaccine, in human DC/T cell assays ex vivo
• Binds to immature DCs and induces both T cell and B cell responses
• Induces
• Activation and proliferation of CD8+ and CD4+ T cells
• Production of IFN-γ and TNF-α in CD8+ and CD4+ T cells
• Production of GrB+, Pfn+ CD8+ and CD4+ T cells
• T cell responses are HIV antigen-specific
• Production of antigen-specific antibodies (IgM)
• Chimigen® HIV Multi-antigen Vaccine shows excellent potential for
further development
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
27
Chimigen® HIV Vaccine
Immune Responses, in vivo, (Rats)
•Evaluation of antigen-specific T and B cell responses
following vaccination
•IFN-γ, IL-4, TNF-α secretion
•Antigen-specific antibodies
•Immune response specificity for recombinant Gag, Env,
Tat,-Rev-Vpr-Vpu (TRVV), and murine IgG1 Fc (mTBD)
Study carried out at VIDO/Intervac (University of Saskatchewan)
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
28
Chimigen® HIV Vaccine
Study Design
Vehicle
Chimigen®
HIV Vaccine
(5, 10, 20 μg)
•
Evaluate immunogenicity of the
Chimigen® HIV Vaccine
•
Female Sprague Dawley rats (3-4 weeks)
divided into groups of 6
•
Animals vaccinated subcutaneously three
times (0, 4, 8 weeks)
•
Chimigen® Vaccine dose: 5, 10, or 20 μg
•
Serum was sampled every two weeks to
assay for antigen-specific antibody
responses to individual HIV antigens and
the mTBD
3x
N=6
Antibody response
Cell-mediated
•
Immune response
Splenocytes were isolated after the third
immunization to assay for antigen-specific
T cell responses
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
29
Chimigen® HIV Vaccine: Summary
• Chimigen® HIV Vaccine is immunogenic; most of the animals responded
• Chimigen® HIV Vaccine is capable of inducing antibody response
• Response is specific for the vaccine component antigens
• Moderate to significant response following the third immunization
• Higher antigen-specific IgG2a antibody titres relative to IgG1;
indicative of a Th1 immune response
– Th1 immune response was vaccine-dose-dependent
– Specific for Vaccine component antigens
– Moderate to significant response following the third immunization
• Effective at low doses
• No added adjuvant
• Chimigen® HIV Vaccine is very effective in inducing systemic cellmediated immune response
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
30
Chimigen® Influenza/Pandemic Vaccines
New Effective Vaccines- Major Unmet Medical Need
6xHis
6xHis
Influenza
H5(H1)-M2
IRD
Influenza
H5(H1)-M2)
CHO
CHO
Peptide Linker
Portion of CH1
S-S
Hinge Region
Generates B Cell and T cell Immunity
S-S
S S
CHO
CH2 S S CCH2
H2
Xenotypic
Murine Fc
CHO
TBD
SS
SS
CH3
CH3
Peptide
Chimigen® Pan-Influenza Vaccine
M2 (Universal): HA (1-9) can be produced, stored as Baculovirus stock
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
31
Chimigen® WEEV Vaccine
No Approved Vaccine Currently Available
6xHis
Alphaviruses – Viral Encephalitis
6xHis
WEEV
E1-E2
WEEV
E1-E2
• Single stranded RNA viruses: Venezuelan Equine
CHO
IRD
CHO
Peptide Linker
Encephalitis (VEEV), Western Equine Encephalitis
Portion of CH1
S-S
Hinge Region
S-S
(WEEV), Eastern Equine Encephalitis (EEEV)
SS
• Viruses can be aerosolized and are highly infectious
CHO
CH2
SS
CHO
CCH2
H2
Xenotypic Fc
• No definitive anti-viral treatment
TBD
SS
• VEEV and WEEV have been successfully weaponized
• Current Vaccine development focused on live, attenuated viruses
• Significant side effects
SS
CH3
CH3
Peptide
Showed efficacy
in challenge model at DRDC-Suffield
• Potential to mutate into virulent strains
• Conventional Adjuvant Vaccines not showing promise
• Applied for NIH (BARDA) grant, 2007- 2008
• US $14.8 mil. (3+1 Years)
• Received high technical merit ranking (109),
possible to reapply
• Anthrax priority (92 & 121)
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
32
Chimigen® WEEV Vaccines
Chimigen® WEEV E2 Vaccine
Chimigen® WEEV E2-E11-200Vaccine
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
Chimigen® WEEV Vaccine: Results Summary
•
Chimigen® E2 and Chimigen® E2-E11-200 Vaccines (WEEV)have been produced
•
Chimigen® WEEV vaccines bound to DC
•
•
Chimigen ® E2 Vaccine used to immunize mice
•
•
Bound to CD32 & CD 206
Immunized mice generated a strong antibody response
•
IgG1 > IgG2a
•
Antibody response was Th2 biased
•
Modest T cell proliferation and IFN-γ production was observed
Chimigen ® WEEV E2 and E2-E11-200 Vaccines used to immunize mice
•
Mice were subsequently challenged with live-WEEV
•
Chimigen ® WEEV vaccines shifted survival curve in a subset of the animals
•
There was one survivor in the Chimigen ® E2-E11-200 vaccinated mice
•
The vaccine showed protection against WEEV challenge
•
This shows early proof of concept for the Chimigen® WEEV Vaccine
34
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
Chimigen® Ebolavirus Vaccine
Ebolavirus (EBOV)
• Filovirus
• BSL 4 pathogen (WHO), Category A (CDC)
• 19kB linear negative-sense RNA genome
– Encodes 7 genes
• Five species:
– Cote d’Ivoire EBOV (ICEBOV)
– Reston EBOV (REBOV)
– Bundibugyo EBOV (BEBOV)
– Sudan EBOV (SEBOV)
– Zaire EBOV (ZEBOV)
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
35
Chimigen® Ebolavirus Vaccine
Multiple Ebola Virus Antigen Targets
6xHis
6xHis
Ebola antigens
GP-NP-VP40
Ebola antigens
GP-NP-VP40
CHO
IRD
CHO
Peptide Linker
Portion of CH1
Hinge Region
S-S
S-S
S S
Xenotypic
(Murine)Fc
CHO
CHO
CH2 S S CCH2
H2
TBD
SS
CH3
SS
CH3
Predicted to Induce Humoral and Cellular Immune Responses
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
36
Cancer Vaccine Program: Early Discovery
Rationale
MUC1
5xTandem
Repeat
Chimigen® Vaccine designs have demonstrated ability to,
• Target dendritic cells
• Produce functional CTLs
• Overcome immune tolerance
• Overcome immune anergy
• Overcome antigenemia
MUC1
5xTandem
Repeat
CHO
IRD
CHO
Peptide Linker
Portion of CH1
S-S
Hinge Region
S-S
SS
CHO
CH2 S S CCH2
H2
Xenotypic
Murine Fc
CHO
TBD
SS
SS
CH3
CH3
Peptide
MUC1 is over-expressed in a large number of carcinomas
Novel immunotherapy without the individualized (Autologous) vaccine concept
Antigen
MUC1
Cancer Targets
Under Development/
Consideration
Carbonic anhydrase IX (CA9)
Carcinoembryonic antigen
(CEA)
HER 2/neu
Prostatic acid phosphatase
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
Cancers
Overexpressed in multiple cancers;
Breast, ovarian, colon, pancreas,
rectal
75% of Cervical and colon cancers
and 95% of renal cancers
65% of breast cancers, 70% of lung
cancers and almost 100% of colon
cancers
Breast, ovarian and colorectal solid
tumors
Prostate Cancer
…..…………..Our focus is on vaccines
37
Chimigen® MUC 1 Cancer Vaccine
MUC1
MUC1
10xTandem
Repeat
10xTandem
Repeat
CHO
IRD
CHO
Peptide Linker
Portion of CH 1
S-S
Hinge Region
S-S
SS
CHO
CH 2 S S CCH2
H2
Xenotypic
Murine Fc
CHO
TBD
SS
SS
CH 3
CH 3
Tandem repeat sequence:
ACC TCG GCC CCG GAC ACC AGG CCG GCC CCG GGC TCC ACC GCC CCC CCA GCC CAC GGT GTC
T
S
A
P
D
T
R
P
A
P
G
S
T
A
P
P
A
H
G
V
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
38
Chimigen® Prostate Cancer Vaccine
PAP
PAP
CHO
IRD
CHO
Peptide Linker
Portion of CH 1
S -S
Hinge Region
S -S
S S
CHO
CH 2
S S
CHO
CCH2
H2
TBD
Xenotypic
( Murine ) Fc
S S
S S
CH 3
CH 3
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
39
Chimigen® CEA Cancer Vaccine
CEA
CEA
CHO
IRD
CHO
Peptide Linker
Portion of C H 1
S-S
Hinge Region
S-S
S S
CHO
CH 2
S S
CHO
CCH2
H2
TBD
Xenotypic
( Murine ) Fc
S S
S S
CH 3
CH 3
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
40
Chimigen® Malaria Vaccine
Initial Development
Funded by
Gates Foundation Award
GCE 3
•
leading cause of death worldwide
• Endemic in 108 countries
• 40% (3 billion) of world population
exposed to parasite
6xHis
6xHis
• Estimated 247 million cases worldwide
IRD
• Over 1 million deaths annually
• 80% deaths occur in children under 5
(weak acquired immunity)
• Pregnant women more susceptible
Xenotypic
TBD
(Murine)Fc
(pregnancy associated malaria)
• Vertical transmission is a major cause
of miscarriage and stillbirth
Targets the parasite
• No approved vaccine to prevent malaria at multiple stages of the infection
• Ready for animal studies
5th
Malaria
antigens
Malaria
antigens
(CSP/AMA-1/LSA120 repeats/MSP-142)
(CSP/AMA-1/LSA120 repeats/MSP-142)
HBV Core
HBV Core
CHO
CHO
Peptide Linker
Portion of CH1
Hinge Region
S-S
S-S
S S
CHO
CHO
CH2 S S CCH2
H2
SS
CH3
SS
CH3
Peptide
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
41
Chimigen® Mtb Multi-antigen Vaccine
Targets tuberculosis at various stages of the infection
6xHis
6xHis
Mtb Antigens
(Ag85b/ESAT6/
Rv2660c/HspX/
RpfA/RpfD)
Mtb Antigens
(Ag85b/ESAT6/
Rv2660c/HspX/
RpfA/RpfD)
CHO
IRD
CHO
Peptide Linker
Portion of CH1
S-S
Hinge Region
S-S
SS
CHO
CH2
SS
CHO
CCH2
H2
Xenotypic Fc
TBD
SS
SS
CH3
CH3
Peptide
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
42
Chimigen® TB Multi-antigen Vaccine
Tuberculosis (TB)
•
•
•
Targets tuberculosis at
various stages of the
infection
Caused by Mycobacterium tuberculosis
8.7 million new cases in 2011
6xHis
Mtb Antigens
1.4 million deaths in 2011
(Ag85b/ESAT6/
– 430,000 people with HIV
– 70,000 children
– Leading killer of people with HIV
•
CHO
CHO
Portion of CH1
S-S
Hinge Region
S-S
SS
CHO
CH2 S S CCH2
H2
Xenotypic Fc
CHO
TBD
SS
– Not recommended in HIV+ children
SS
CH3
(WHO Global Advisory Committee)
CH3
Peptide
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
IRD
Peptide Linker
630,000 people with MDR-TB in 2011
Current vaccine (M. bovis BCG) low
efficacy
Mtb Antigens
(Ag85b/ESAT6/
Rv2660c/HspX/
RpfA/RpfD)
Rv2660c/HspX/
RpfA/RpfD)
– 150,000 deaths annually from MDR-TB
– 10% of MDR-TB are EDR-TB
•
6xHis
…..…………..Our focus is on vaccines
43
Akshaya Bio Inc.
Intellectual property Portfolio
Issued Patents
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
44
Akshaya Bio Inc.
CHIMERIC ANTIGENS FOR ELICITING AN IMMUNE RESPONSE
Issue
Expiry
Country Status Application No.Filing Date Patent No. Date
Date
10/365,620
13-Feb-03
05-Feb-24
United
States
Issued
8,029,803 04-Oct-11
Country
Status
United States Issued
United States Issued
Application
No.
Filing Date Patent No.
10/912,969 5-Aug-04 8,025,873
13/209,979 15-Aug-11 8,465,745
Issue Date Expiry Date
27-Sept-11 05-Feb-24
18-Jun-13 13-Feb-23
HEPATITIS B FAMILY
CHIMERIC ANTIGENS FOR BREAKING HOST TOLERANCE TO
FOREIGN ANTIGENS
Country
Germany
(Europe)
France
(Europe)
Status
Issued
Issued
Application
No.
Filing Date Patent No.
602004045 6-Aug-04
169.9
166270
04761663.9 06-Aug-04
166270
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
Issue Date Expiry Date
06-Aug-24
21-May-14
06-Aug-24
21-May-14
…..…………..Our focus is on vaccines
45
Akshaya Bio Inc.
HEPATITIS B FAMILY
CHIMERIC ANTIGENS FOR BREAKING HOST TOLERANCE TO
FOREIGN ANTIGENS
Expiry
Country Status Application No. Filing Date Patent No. Issue Date Date
United
10/913,171
5-Aug-04
05-Feb-24
States
Issued
8,007,805 30-Aug-11
China
Issued 200480022 6-Aug-04 ZL
27-Apr-11 6-Aug-24
747.1
200480022
747.1
Eurasia
Issued 200600390. 6-Aug-04 13070
26-Feb-10 6-Aug-24
(validated in
0
RU)
India
Issued 00256/MU 6-Aug-04 225281
MNP/20
UK (Europe) Issued 04761663.9 6-Aug-04 1664270
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
5-Nov-08 6-Aug-24
21-May-14 6-Aug-24
…..…………..Our focus is on vaccines
46
Akshaya Bio Inc.
HEPATITIS B FAMILY
CHIMERIC ANTIGENS FOR BREAKING HOST TOLERANCE TO
FOREIGN ANTIGENS
Japan
Issued 2006-522192 6-Aug-04 5200201
New Zealand Issued 545048
6-Aug-04 545048
22-Feb-13 6-Aug-24
8-Oct-09
6-Aug-24
Singapore
Issued 200600745-4 6-Aug-04 119567
29-Aug-08 6-Aug-24
Taiwan
Issued 93123603.0 6-Aug-04 I364294
21-May-12 6-Aug-24
South Africa Issued 2006/00804 6-Aug-04 2006-0804 25-Apr-07 6-Aug-24
Korea
Issued 10-20067002648
6-Aug-04 10-13277194-Nov.13 6-Aug-24
Australia
Issued 2012200998 6-Aug-04 2012200998 27 Feb.14 6-Aug-24
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
47
Akshaya Bio Inc.
HEPATITIS C FAMILY
CHIMERIC HEPATITIS C VIRUS ANTIGEN FOR ELICITING AN IMMUNE
RESPONSE
Singapore Issued 200802303-8 13-Oct-06 141061 29-Oct-10 13-Oct-26
South
Issued 2008/04078 13-Oct-06 2008/040 30-Sep-09 13-Oct-26
Africa
78
Si RNA FAMILY
ANTIGENIC COMPOSITIONS AND USE OF SAME IN THE TARGETED
DELIVERY OF NUCLEIC ACIDS
New
Zealand
584306
29-Jan- 29-AugIssued 584306
29-Aug-08
13
28
20088011360
ZL20088011 10-Dec- 29-AugChina
Issued 1.6
29-Aug-08 36016
14
28
12/67556 26-Feb- 8637477 284-MarUSA
Issued USA
Issued
0
10
Jan-14 29
Australia
Issued 2008291604 29-Aug-08 20082916 20-Mar-14 29-Aug-28
04
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
48
Akshaya’s Competitive Advantages
 Product candidates meet major unmet needs
 No vaccine/therapy available
 Re-educates the immune system
 Targets Dendritic Cell Receptors
 Natural process for uptake and presentation of antigens
 Most efficient and natural process of antigen delivery to DCs
 Efficacy Demonstrated
 Proof of Concept established
 Using immune cells from HBV Chronic Carriers
 HBV vaccine candidate breaks the immunological tolerance
to HBV antigens
 No Adjuvant
 Eliminates majority of the adverse reactions
 Strong Intellectual Property Position
 23 issued patents, 17 pending applications, USA & World
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
49
Chimigen® Vaccine Platform - Highlights
• Versatile, Adaptable Platform
• Dendritic Cell Receptor-Targeted Vaccines
• Generates broad immune responses
• Cellular (Class I) - critical to clear virus-infected & cancer cells
• Humoral (Class II) – Abs- Helps CTLs
• Proof of principle established
• Chimigen® HBV Therapeutic Vaccine
• Potential use for Prophylactic & Therapeutic Vaccines
• Strong Intellectual Property Position
• 23 Issued Patents, USA and World
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
50
Akshaya Bio Inc.
Contact Information
Rajan George, M.Sc, Ph.D
President & Chief Scientific Officer
8223 Roper Road
Edmonton
Alberta, T6E 6S4
Canada
Telephone 780 989 6705
Mobile
780 493 1706
email
[email protected]
Web
www.akshayabio.com
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
51
Akshaya Bio Inc.
Thank You…….
© 2015 Akshaya Bio | www.akshayabio.com
Akshaya Bio Inc.
…..…………..Our focus is on vaccines
52