Pioneering vaccines that transform lives.

Transcription

1 Pioneering vaccines that transform lives.

2 Immunomic Therapeutics, Inc. LAMP-Vax for General Oncology

3 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 immunooncology 5. Partnering objectives and timeline

4 Immunomic Therapeutics: Company Overview

5 Immunomic Therapeutics Corporate Overview: Successful Platform Technology Company 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

6 Immunomic Therapeutics Strong Management & Capabilities Prime Partner for Pharma 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

7 R&D, PD and Clinical Dev Process From Idea to POC in Animals in a Year

8 R&D, PD and Clinical Dev Process Capabilities Through end of Phase II

9 Unmet Need Within Current Immunotherapy Landscape

10 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 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. 1

11 LAMP-Vax Platform

12 The LAMP-Vax Platform: Mode of Action Th1 Response and Relevance

13 The LAMP-Vax Platform MOA & Results Strengthens Immune Response and Creates Memory 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

14 LAMP-Vax Modalities, Existing Data & Current Application Areas

15 LAMP-Vax Platform for Oncology A Stand Alone Platform and Additive to Other Platforms Multiple Antigens Multiple Modalities Multiple Tumors Viral Autologous Dendritic Cell GBM Self/Overexpressed Plasmid DNA AML (Blood) Cancer Testes Neo antigen mrna (naked or liposomal) Combination (e.x. pdna with Adeno) 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.

16 Patient Number Duke pp65-lamp DC Clinical Studies PFS & OS Data for pp65-lamp DCs + RT + TMZ Overall Survival of pp65-lamp DC Therapy (months) Historical OS, 20 months 1 pp65-lamp, no Td/GM-CSF pp65-lamp, Td prime pp65-lamp, GM-CSF Alive as of Sept. 9, OS from diagnosis Sources: Mitchell DA et al., Nature Vol March and Batich KA et al., Clin Cancer Res; 23(8) April 15, ITI analysis of GBM TCGA dataset, restricted to KPS>80 receiving RT + TMZ

17 Current LAMP-Vax Focused Strategy 3 Key Approaches Currently Being Tested Antigen Categories & Programs Viral Antigens Neo Antigens Ca Testes & Overexpressed Additional studies in progress with CMV & others (eg. HPV) LAMP-Vax: enhanced immune response (e.x. CD4 epitopes) & quick TAT platform Various targets being explored, including cancer testes ags., various approaches (e.g. epitope) Phase I data available, Phase II ongoing, new animal data in progress Data in animals being generated in-house & in collaboration: available Q2/ New animal model data available, more in by Q In house and under collaboration tested in models & humans in multiple tumors.

18 Robust Product Pipeline Allergy, Animal Health, Oncology Design Animal 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

19 Conclusions

20 Billions, USD Cancer Immuno-Oncology Market Too Large to Miss Oncology drug market $85B in $120B - $135B by Cancer immunotherapy market estimates are up to $30-40B by Immunotherapy drugs will be treating 60% of cancers in next 10 years Cancer vaccines market Market Growth of Oncology Drugs $7.5B by 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 1 source: Bloomberg 2 source: IMSHealth 3 source: GlobalData Pharma etrack 4 source: GBI Research; includes HPV vaccines

21 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 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

22 Conclusions LAMP-Vax and Cancer Immunotherapy 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

23 Thank You Sia Anagnostou Sr. Director of Corporate Development Immunomic Therapeutics, Inc. Tel: Headquarters & Lab: Rockville, MD TEL: twitter.com/immunomix