Vectus Biosystems Limited · ASX:VBS
Vectus Biosystems — Shareholder Meeting (November 2019)
23 slides from Vectus Biosystems's shareholder meeting presentation, Nov 22, 2019
Slide 1: VIP Agonists – The Benchmark for Anti-Fibrotics
For personal use only VIP Agonists VIP–Agonists – The BenchmarkThe for Benchmark for Anti-FibrosisAnti-Fibrotics
Slide 2: Overview
OVERVIEW Fibrosis is the replacement of normal tissue For personal use only (heart, lung, kidney etc) by scar tissue and can lead to organ failure Fibrosis is the pathology which underlies: Heart failure (largest single item on US health care budget ($US32b in 2013) Kidney failure (Dialysis and
Slide 3: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive Sufficient Patent Life Ph
Slide 4: Lead Drugs in Significant Areas
LEAD DRUGS IN 4 SIGNIFICANT AREAS For personal use only • Heart and kidney failure constitute the largest current imposts on healthcare budgets world-wide • Although there are many causative factors the underlying pathology is replacement of normal functioning tissue by Cardiovascular fibrous (“scar
Slide 5: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Goods Competitive IP Covers Composition of Matter Sufficient Patent Life P
Slide 6: Target Validation
TARGET VALIDATION For personal use only Normotensive rats on 4.4% 2.5 2 Myocardial VIP (fmol/gram) 1.5 1 0.5 R2=0.7446 0 0 1 2 3 4 Myocardial Fibrosis (% surface area) Hypertensive rats on 2.2% salt diet L-NAME Treated rats In the heart VIP depletion was associated with increasing fibrosis. Above VI
Slide 7: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Goods Competitive IP Covers Composition of Matter Sufficient Patent Life P
Slide 8: VB0004 & Cardiac Fibrosis
VB0004 & CARDIAC FIBROSIS For personal use only Treatment with VB0004 at 3 Doses 20 ## VB0004 Myocardial Fibrosis (% surface area) VB0004 has been shown to: 15 * ** # 10 ** • Rescue cardiac tissue damaged by fibrosis • Repair existing cardiac damage 5 • i.e. VB0004 is transformational • Reduce systo
Slide 9: VB0004 & Kidney Fibrosis
VB0004 & KIDNEY FIBROSIS Treatment with VB0004 at 3 Doses For personal use only 35 ## In the kidney VB0004 has been shown to: VB0004 Renal Interstitial Fibrosis (% surface area) 30 •Reverse renal interstitial fibrosis at all doses 25 * # 20 * •Restore normal architecture at all doses 15 ## * • i.e.
Slide 10: VB0004, VB4-A79 & Pulmonary Fibrosis
VB0004, VB4-A79 & PULMONARY FIBROSIS For personal use only 30 Pulmonary Fibrosis (% surface area) In the lung: # # 20 * •VB4-A79 and VB0004 reversed fibrosis * present 2 weeks after treatment with bleomycin (an anti-cancer drug) 10 •i.e. both are considered transformational 0 Control 16 VB0004 A79 C
Slide 11: VB4-A32 & Hepatic Cirrhosis
VB4-A32 & HEPATIC CIRRHOSIS For personal use only 10 VB4-A32 demonstrated ability to Hepatic Fibrosis (% surface area) 8 * •reduce peri-portal fibrosis in the liver in 6 ** ** ** a dose dependent manner (right and 4 below) 2 •Improve liver function tests (below right) 0 14 W ee k C o n tro l A3 2/10
Slide 12: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Goods Competitive IP Covers Composition of Matter Sufficient Patent Life P
Slide 13: Demonstrated Safety
DEMONSTRATED SAFETY For personal use only •SAD and MAD (2 species) Single Ascending Dose (SAD) to 2,000mg/kg no adverse events 7 day Multiple Ascending Dose (MAD) to 2,000mg/kg no adverse events 28 day MAD to 500mg/kg no adverse events • Cardiovascular safety hERG studies - low arrhythmia potent
Slide 14: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Goods Competitive IP Covers Composition of Matter Sufficient Patent Life P
Slide 15: Synthesis Scale and Cost
SYNTHESIS SCALE AND COST For personal use only •Patent covering GMP synthesis method •3 step synthesis •GMP synthesis by Glycosyn(www.glycosyn.com) •Yield has increased as scale has increased •VB0004 manufactured to 5kg scale •Cost efficient at 5kg scale < $(US) 0.05 per mg •Estimated dose 1-5mg •St
Slide 16: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Validated Target Transformational Agent Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Goods Competitive IP Covers Composition of Matter Sufficient Patent Life P
Slide 17: Intellectual Property
INTELLECTUAL PROPERTY For personal use only •VB0004 patent covers compositions of matter methods of use •VB0004 Patent granted in all major jurisdictions USA, Europe, Japan, Peoples Republic of China, Republic of South Korea, Russian Federation as well as Australia, Israel, Phillipines, South Af
Slide 18: Path to the Clinic
PATH TO THE CLINIC For personal use only Pharma criteria Vectus Platform Technology Transformational Agent Validated Target Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology Synthesis at Scale Cost of Good Competitive IP Covers Composition of Matter Sufficient Patent Life Ph
Slide 19: Phase I
PHASE 1 For personal use only • Syneos Health (Nasdaq SYNH) retained to write Investigator Brochure (IB) and trial protocol • Trial design conventional Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) • Healthy subjects 14 day MAD • Affected individuals 2 groups 28 days 2 doses • Biomar
Slide 20: About Syneos Health
ABOUT SYNEOS HEALTH For personal use only • In a recent 5 year period Syneos has helped develop or commercialise 91% of novel new drugs approved by the FDA 90% of products granted marketing authorisation by the EMA • Has more than 25 years Phase 1 operations experience • Has dedicated Phase 1 mo
Slide 21: Comparable Transactions
COMPARABLE TRANSACTIONS Vectus could see a substantial upside if Phase I and IIa trials for VB0004 drug candidates are successful For personal use only MARKET METRICS – RECENT TRANSACTIONS • It is feasible that positive clinical data from the Phase IIa trial could see Vectus negotiate an agreement
Slide 22: Patent Portfolio
PATENT PORTFOLIO For personal use only •VIP patents for heart, kidney and aortic fibrosis of hepatic, cardiac and renal fibrosis – granted – granted all jurisdictions US, accepted Europe, Australia, South Africa •VIP fragment patents compositions and •P5 and library of related compounds methods of u
Slide 23: VIP Agonists – The Benchmark for Anti-Fibrotics
For personal use only VIP Agonists VIP–Agonists – The BenchmarkThe for Benchmark for Anti-FibrosisAnti-Fibrotics
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