Pioneering - Immunomic Therapeutics, Inc · 2017-06-15 · Combination (e.x. pDNA with Adeno)...
Transcript of Pioneering - Immunomic Therapeutics, Inc · 2017-06-15 · Combination (e.x. pDNA with Adeno)...
Presentation Outline
1. Immunomic Therapeutics: corporate overview
2. Unmet need in cancer immunotherapy landscape
3. How cancer vaccines & LAMP-Vax™ in particular is a
potential solution to current shortcomings
4. Existing data & current focus for LAMP-Vax in immuno-
oncology
5. Partnering objectives and timeline
Immunomic Therapeutics
• Privately held company, based in Rockville MD, founded in 2006
• LAMP-Vax™ (Lysosomal Associated Membrane Protein) platform
• Strong preclinical & clinical results in allergy and cancer
• Funded by angels & family offices; less than $20 million
• In 2015, created over $317 million in licensing revenue; 2 deals with
Astellas, and over a 5-6x return for investors
• Applying LAMP-Vax to cancer immunotherapy to combat cancer &
broaden immunotherapy use and to animal health applications
Corporate Overview: Successful Platform Technology Company
Immunomic Therapeutics
Technically focused company ~30 employees
• Over ½ employees in R&D and PD + seasoned management
• In-house clinical trial & GMP experience & capabilities
Successful working relationship with pharma 3 years into license:
• ASP-0892 (Peanut Ph I – granted FDA Fast Track designation)
• ASP-4070 (Japanese red cedar) program in Ph II clinical studies
Delivery of GMP grade vaccine for clinical studies
R&D/PD/Clinical capabilities drive LAMP-Vax forward in cancer immunotherapy
• R&D, Process Development & Manufacturing Management
Strong Management & Capabilities – Prime Partner for Pharma
LAMP-Vax in the Immuno-Oncology Landscape
Solution: Cancer Vaccines to Generate High Affinity T Cell Responses
Inflamed Excluded Infiltrate Immune Desert
T cells infiltrated,
but non-functional
T cells accumulated but
not efficiently infiltrated
T cells absent from
tumor and periphery
1 http://dx.doi.org/10.1016/j.immuni.2013.07.012
Left: Inflamed tumor, where checkpoint inhibition is active.
Center: Inflamed tumor but microenvironment may prevent immune system from getting in.
Right: No immune response present, “cold tumor”.
LAMP-Vax has the potential advantage in creating high affinity CD8 by supporting helper T cells, which could add
therapeutic value to each of these categories/states.
The LAMP-Vax Platform MOA & Results
LAMP-Vax Mode of Action
• Effect presentation to the immune system via professional antigen presenting cells
• Synthesize native proteins directly in the cell
• Trafficking motif moves chimeric proteins into the MHC-II compartment in a protected
format with high efficiency
Results in:
• Antigen presentation to the MHC-II without any folding or pre-digestion issues
• Broad immune response; helper T cells elicit a humoral response while also
expanding and improving the activity of CD8+ cells
• Compatible with other therapeutics
Strengthens Immune Response and Creates Memory
LAMP-Vax Platform for Oncology
A Stand Alone Platform and Additive to Other Platforms
Multiple Antigens
Viral
Self/Overexpressed
Cancer Testes
Neo antigen
Multiple Modalities
Autologous Dendritic
Cell
Plasmid DNA
mRNA (naked or
liposomal)
Combination (e.x. pDNA
with Adeno)
Multiple Tumors
GBM
AML (Blood)
Breast/Ovarian
Prostate
ITI is exploring and exploiting the various ways that the flexible LAMP-Vax
platform technology is applicable and complementary to other approaches.
Duke pp65-LAMP DC Clinical Studies
PFS & OS Data for pp65-LAMP DCs + RT + TMZ
Overall Survival of pp65-LAMP DC Therapy (months)
0 10 20 30 40 50 60 70
15161718
420
692
2219
121142313
78
245
123
1011
OS from diagnosis
Pa
tie
nt
Nu
mb
er
pp65-LAMP, no Td/GM-CSF
pp65-LAMP, Td prime
pp65-LAMP, GM-CSF
Alive as of Sept. 9, 2016
Historical OS, 20 months1
Sources: Mitchell DA et al., 2015. Nature | Vol 51 9 | 19 March and Batich KA et al., 2017. Clin Cancer Res; 23(8) April 15,
2017. 1 ITI analysis of GBM TCGA dataset, restricted to KPS>80 receiving RT + TMZ
Current LAMP-Vax Focused Strategy
3 Key Approaches Currently Being Tested
Antigen Categories & Programs
Viral Antigens
Additional studies in
progress with CMV &
others (eg. HPV)
Ca Testes &
Overexpressed
Neo Antigens
Various targets being
explored, including cancer
testes ags., various
approaches (e.g. epitope)
LAMP-Vax: enhanced
immune response (e.x. CD4
epitopes) & quick TAT
platform
Phase I data available,
Phase II ongoing, new
animal data in progress
New animal model data
available, more in by
Q2 2017
Data in animals being
generated in-house & in
collaboration: available Q2/3
2017
In house and under collaboration tested in models & humans in multiple
tumors.
Robust Product Pipeline
Allergy, Animal Health, Oncology
DesignAnimal POC
Pre-Clinical
Ph. I Ph. II Ph. III Partner / Collaborator
ALLERGY VACCINE THERAPY
ASP-4070 • Japanese red cedar Astellas
ASP-0892 • Peanut Astellas
LAMP-Vax • Undisclosed allergy Astellas
CAD-LAMP-Vax • Allergy in dogs Internal
ONCOLOGY IMMUNOTHERAPY
AST-VAC1 • AML BioTime / Asterias
GBM-LAMP-Vax • Glioblastoma UF/Duke/Annias
AST-VAC2 • NSCLC BioTime / Asterias
Viral Ag LAMP-Vax UF & Internal
Epitope LAMP-Vax Internal
Neoantigen LAMP-Vax Internal
CA Ag LAMP-Vax Internal
Cancer Immuno-Oncology
Market Too Large to Miss
Oncology drug market
• $85B in 20151
• $120B - $135B by 20212
Cancer immunotherapy market
• estimates are up to $30-40B by 20233
• Immunotherapy drugs will be treating 60% of cancers in next 10
years
Cancer vaccines market
• $7.5B by 20224
• Cancer Vaccines market growing in excess of 30% per year
High pharma interest in oncology market
• 2016 Average Deal Value: over $1B
• 2016 Average Upfront Payment: over $300M
ITI will leverage the foundation
that it has on high unmet need
Ph I/II LAMP vaccines in
prostate, AML, melanoma and
GBM
62
85
127
0
20
40
60
80
100
120
140
160
2010 2015 2021
Bill
ion
s, U
SD
Market Growth of Oncology Drugs
1 – source: Bloomberg
2 – source: IMSHealth
3 – source: GlobalData Pharma eTrack
4 – source: GBI Research; includes HPV vaccines
Seeking Business Development Opportunities
Summary, Timeline & Objectives
LAMP-Vax in a Phase II study in GBM and Phase I in NSCLC.
Testing in animal models to demonstrate potential POC in
various tumor types in 2017.
Data/information available under CDA in 2017:
• Existing body of Phase I and II data employing LAMP
• Mechanism of action (MoA) data (support from allergy work)
• Animal data with candidate LAMP-Vax in various tumor
models w/ preferred platform for LAMP-Vax.
• Additional information (IP, regulatory, manufacturing)
In 2017, initiating formal BD discussions with Pharma for
transaction/collaboration in oncology and animal health.
Preferred Transactions:
• Exclusive WW rights for all oncology applications OR
• Focus on specific cancer(s), products OR geography
• Willing to consider alternatives
LAMP-Vax Nucleic Acid Vaccine Platform:
Fulfills an Unmet Need in Cancer
Immunotherapy
Could activate Th1 Type Tumor Specific T
cell responses at the tumor: turn cold
tumors “hot.”
Strong foundation with LAMP-Vax
specifically in allergy & oncology
Growth since two significant licenses with
Astellas Pharma in 2015
Immunomic: prime target for partnerships
with pharmaceutical companies in
immuno-oncology
Conclusions
LAMP-Vax and Cancer Immunotherapy
Thank You
Headquarters & Lab: Rockville, MD
TEL: 301-968-3501
www.immunomix.com
twitter.com/immunomix
Sia Anagnostou
Sr. Director of Corporate Development
Immunomic Therapeutics, Inc.
email: [email protected]
Tel: 717 327 1822