Invion Ltd. · ASX:IVX
Invion — Investor Presentation (February 2014)
27 slides from Invion's investor presentation, Feb 26, 2014
Slide 1: Invion Limited: Corporate Presentation February 2014
For personal use only Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Corporate Presentation February | 2014
Slide 2: Disclaimer
For personal use only Disclaimer This presentation has been prepared by Invion Limited (Invion or the Company) solely for its use at presentations to be made by the Company. The information contained in this presentation is an overview and does not contain all information necessary to make investmen
Slide 3: Invion: targeting inflammation
Invion: targeting inflammation > 3 drug candidates in development For personal use only > Developing two new respiratory franchises > INV102 (nadolol): beta blocker being repurposed to treat inflammatory airway diseases > INV104 (zafirlukast): anti-leukotriene being developed as inhaled product for
Slide 4: Management team with proven track record
Management team with proven track record Invion’s management and board have significant experience repurposing drugs for new For personal use only markets and guiding drugs through FDA regulatory and approval processes. Greg Collier, PhD., Managing Director and Chief Executive Officer > 20 year care
Slide 5: Recent capital raise and development collaboration
Recent capital raise and development collaboration allow acceleration of clinical development For personal use only > Collaboration with 3M Drug Delivery systems > Inhalation development expertise > Proprietary formulation and device > Collaboration will assess the feasibility of inhaled INV102 (nad
Slide 6: Invion pipeline focuses on enhanced shareholder value
Invion pipeline focuses on enhanced shareholder value For personal use only Next Milestone Airway Inflammation Non-clinical IND Phase I Phase II (calendar year) INV102 (nadolol) = beta adrenergic inverse agonist Completion Oral: Asthma Nadolol in Mild Asthma (NIMA) clintrials.gov 1H 2015 EOPII Oral:
Slide 7: Targeting respiratory disease
For personal use only Targeting respiratory disease INV102 (nadolol) – beta adrenergic inverse agonist INV104 (zafirlukast) - leukotriene receptor antagonist
Slide 8: Spectrum of airway disease and opportunities
Spectrum of airway disease and opportunities For personal use only Global market size: $34B $2.4B $1.2B Exercise Mild Moderate Severe Chronic Smoker’s Cystic Induced Asthma Asthma Asthma Bronchitis cough Fibrosis Asthma Zafirlukast: Monotherapy + combinations Nadolol: Monotherapy + combinations 8
Slide 9: INV104 (zafirlukast)
INV104 (zafirlukast) For personal use only > Nanomolar potent Leukotriene Receptor Antagonist (LTRA) or anti-leukotriene > Targeted as first inhaled non-steroidal anti-inflammatory treatment for asthma > Large market potential with mitigated risk of a reformulated drug > Accolate® (zafirlukast) > De
Slide 10: INV102 (nadolol)
INV102 (nadolol) Nadolol is uniquely an inverse -agonist in the airway For personal use only > > inactivates intracellular inflammatory events that are stimulated spontaneously or by agonists > Hypothesized to utilize the beta-arrestin pathway > Clinical data to date > Two phase II clinical trial
Slide 11: Preclinical studies demonstrate airway healing
Preclinical studies demonstrate airway healing For personal use only Control lung tissue Lung tissue of ‘asthmatic’ mice: epithelial Lung tissue of ‘asthmatic’ mice treated cells have been converted to mucus- with INV102 (nadolol) for 28 days: producing goblet cells. No effect of restored epithelium
Slide 12: Severe airway diseases share the phenotype
Severe airway diseases share the phenotype For personal use only Severe COPD Asthma Cystic Fibrosis 12
Slide 13: Medical, regulatory and commercial precedent
Medical, regulatory and commercial precedent For personal use only Precedent: Chronic Heart Failure (CHF) FROM TO CONTRAINDICATED STANDARD OF CARE Warning against use of After careful titration, beta blocker beta blockers in CHF for > 25 years. Carvedilol reduced mortality in Carvedilol annual sales
Slide 14: INV102: phase II trial design – mild asthma
INV102: phase II trial design – mild asthma Trial name INV102 (nadolol) in mild asthma (NIMA) For personal use only Trial design Double-blinded, randomised, placebo-controlled, multi-centre Patients 60 subjects (30 subjects in each of two treatment arms) Timing Commenced 2013 Expected completion 201
Slide 15: INV102: phase II trial design – smoking cessation
INV102: phase II trial design – smoking cessation Trial name INV102 (nadolol) in smoking cessation of patients with pre-existing COPD For personal use only Trial design Double-blinded, randomised, placebo-controlled Patients 130 (65 per arm: 54 needed for analysis) Timing Commenced 2013 Expected Com
Slide 16: Respiratory therapeutics: inhaled program
For personal use only Respiratory therapeutics: inhaled program INV102 (nadolol) in COPD & cystic fibrosis INV104 (zafirlukast) in asthma
Slide 17: INV102 (nadolol): comparison oral vs inhaled
INV102 (nadolol): comparison oral vs inhaled Target Product Profile For personal use only Oral Inhaled IP protection based on titration and method of IP protection based on 3M formulation and use (USA) device Once daily dosing including titration to avoid Once daily dosing with no need for titration
Slide 18: INV104 (zafirlukast): comparison oral vs inhaled
INV104 (zafirlukast): comparison oral vs inhaled For personal use only Target Product Profile Oral (Accolate®) Label Inhaled (INV104) Astra Zeneca patent for zafirlukast expired IP protection based on 3M formulation and device Twice per day dosing with food effect, suicidal Once (or twice) daily dos
Slide 19: Respiratory pipeline: based on stage of development
Respiratory pipeline: based on stage of development For personal use only Pre-IND Phase I Phase II Phase III INV102 (nadolol) NIH funding: moderate- Asthma oral Mild disease: NIH funded severe asthma Smoking Chronic bronchitis: oral Smoking cessation in patients with pre-existing COPD EOPII cessatio
Slide 20: Targeting inflammatory disease
For personal use only Targeting inflammatory disease INV103 (ala-Cpn10): modified natural human protein
Slide 21: INV103: Mechanism of action
INV103: Mechanism of action For personal use only HSP10 References: Resolution-associated molecular patterns (RAMPs) in the acute inflammatory response. Inflammation initiates the over-expression and release of RAMPs, such as Cpn10 (Hsp10). These help limit and resolve the inflammatory responses via
Slide 22: INV103 (ala-Cpn10): background and rationale
INV103 (ala-Cpn10): background and rationale For personal use only > Minimally modified form of naturally occurring protein > Maintains heptameric structure and function > Intracellular function: prevent protein misfolding > Extracellular function: Cpn10 proposed as a founding member of the Resoluti
Slide 23: INV103: completed clinical trials
INV103: completed clinical trials For personal use only Phase Indication Route Total INV103 Doses patients patients 1a Healthy volunteers IV/SC 19 14 1.2, 5.5, 10mg IV 5mg SC 1b Multiple Sclerosis IV 12 9 2.5 or 5mg, 5 doses 2a Multiple Sclerosis IV 50 39 Placebo, 5mg 2 Ulcerative Colitis IV 8 8 5mg
Slide 24: INV103: phase II trial design – lupus
INV103: phase II trial design – lupus Trial name INV103 (ala-Cpn10) in mildly active Systemic Lupus Erythematosus (lupus) For personal use only Trial design Double-blinded, randomized, placebo-controlled, intravenous dosing Patients 32 subjects (8 subjects per dose cohort, 4 cohorts) Timing Commence
Slide 25: Summary
For personal use only Summary 3 drug assets with multiple paths to market early partnering opportunity for INV103 (ala-Cpn10) 3 FDA-regulated phase II clinical trials two de-risked novel and proprietary inhaled respiratory assets collaboration with global partner on inhaled franchise exp
Slide 26: Corporate snapshot
Corporate snapshot For personal use only Sector Life Sciences (Biotechnology) Principal activities Clinical-stage pharmaceutical drug development Pipeline 3 drug assets, multiple clinical and pre-clinical programs Operations Australia & USA ASX code IVX Share price (21-Feb-14) $0.089 (8.9 cents) Sha
Slide 27: Dr Greg Collier, Managing Director and CEO
For personal use only Dr Greg Collier Managing Director and CEO Invion Limited GPO Box 1557 Brisbane, QLD, 4001 Australia P: +61 7 3295 0500 E: greg.collier@inviongroup.com W: www.inviongroup.com Corporate Presentation February | 2014