Translational Development of IMX101 A Best Practice Model 8. International VPM Days Hannover, September 17th, 2015 Dr.

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1 Translational Development of IMX101 A Best Practice Model 8. International VPM Days Hannover, September 17th, 2015 Dr. Alexander Werner

2 Company History Technische Universität München (Prof. Dr. Markus Gerhard) Focus on chronic and nosocomial infections by creating specific vaccines against immune evasion factors Lead program: Vaccine against Helicobacter pylori, which colonizes the human stomach and is the cause of ulcer disease and gastric cancer BMBF financing: EUR 3.9 million (GO Bio phase I) in September 2011 ImevaX GmbH established in January 2014, spin-out September 2014 Series A financing: EUR 7.5 million raised in July 2014 Lead investor: Wellington Partners Venture Capital Co-investors: BioMedPartners, Santo Venture Capital (Strüngmann family office), EMBL Ventures, KfW (Kreditanstalt für Wiederaufbau) BMBF financing: EUR 5.9 million (GO Bio phase II) in August 2014 Head count: 17 people (10/2015) Management: Marie Roskrow (CEO), Volker Wedershoven (CFO), Prof. Dr. Markus Gerhard (CSO), Dr. Uwe Michaelis (COO), Dr. Alexander Werner (Program Management) 2

3 Helicobacter pylori Medical Need Helicobacter pylori infection a significant medical need H. pylori infection rates WHO: Class 1 carcinogen 70% 30% 40% 30% 50% 90% 70% 70% 70% 85% 80% 20% 70% 20% develop ulcers: double digit M p.a. >1% gastric cancers: p.a. 3 bn infected globally Hurdle for vaccination approaches:» H. pylori blocks the immune response Standard therapy: 2 antibiotics + PPI» Significant side effects» Increasing resistance development! PPI = Proton Pump Inhibitors 3

4 Helicobacter pylori Medical Need Helicobacter pylori infection development of resistance 2020 (e): > 60% untreatable! 2020 (e) Today: > 10% untreatable! Resistance to 1st line 2nd line 3rd line Metronidazol (MZ) 30% 50% 82% Clarithromycin (CLA) 7% 57% 76% Gao et al

5 Helicobacter pylori Vaccination in the Past Why other approaches failed: Antigens were not essential Antigens were not conserved No mucosal route / mucosal adjuvant Adjuvant (Alum) did not induce T-cell response Immune evasion was not addressed 5

6 Scientific Rationale ImevaX ImeScreen platform identifies immune evasion factors 6

7 IMX101 - H. pylori Vaccine H. pylori outer membrane protein Antigen 1» Surface protein with high immunogenicity» Essential for colonization, highly conserved IMX101 H. pylori functional antigen HpgGT Antigen 2» Secreted immunmodulatory protein» Suppresses T cell function» Essential for colonization, highly conserved Adjuvant» Mucosal adjuvant activity» Capable of inducing T cell responses mucosal adjuvant 7

8 IMX101 Preclinical Development Proof of concept and toxicity studies Mouse Prophylactic and therapeutic models Humoral response T cell response Antigen titers Inhibitory antibodies against HpgGT Anti-specific induction of T cells Reduction of HP load 8

9 IMX101 Preclinical Development Proof of concept and toxicity studies Mouse Prophylactic and therapeutic models Humoral response T cell response Antigen titers Inhibitory antibodies against HpgGT Anti-specific induction of T cells Reduction of HP load Monkey Repeat dose toxicity studies naturally HP-infected Rhesus Monkeys Adjuvant alone IMX101 (2015/16) 9

10 IMX101 Clinical Development Feasibility study (currently running) 30 HP-positive 6 HP-negative volunteers Testing of biopsy sampling and logistics Testing of recruitment strategy Establishemt of immune-monitoring assays 10

11 IMX101 Clinical Development Phase 1a/1b study: Randomized, double blind, placebo controlled study on IMX101 Phase 1a HP-negative subjects 2 Regimen 2x 3 Doses Endpoints: Safety / Immunogenicity 11

12 IMX101 Clinical Development Phase 1a/1b study: Randomized, double blind, placebo controlled study on IMX101 Phase 1a HP-negative volunteers 2 Regimen 2x 3 Doses Endpoints: Safety / Immunogenicity Phase 1b HP-infected volunteers 2 Regimen 2x 3 Doses Endpoints: Safety / Immunogenicity / Efficacy 12

13 IP Rights Overview of IMX101 IP position IMX101» Europe: EP patent granted in 2014 (EP B1)» International filing date: October 19, 2007 PCT/EP07/09106» US: notice for allowance issued on February 24, 2015» Applications pending in EP (divisional application), AU, CA, CN, HK, IN, JP» Divisional applications in JP and US in preparation» Patent protection until October 19, 2027 Adjuvant» US 5,917,026 expires in 2016 no PCT application, no EP patent Freedom to operate analysis for IMX101 completed in June

14 What was key on our translational way? Factors of successful transit from preclinical to clinical stage Innovative product (Immune evasion vaccine) Substantial funding of 3.9m + 5.9m (GO-Bio grant I + II) Early introduction of competent consultants like Granzer, Michaelis Consulting, VPM Maximize value of the project within limited academic budget Senior and dedicated founding team 14

15 Founding Team 15

16 Thank you for your attention ImevaX GmbH Grillparzerstr Munich Germany P: E: Supported by 16

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