Invion Ltd. · ASX:IVX
Invion — Investor Presentation (June 2013)
31 slides from Invion's investor presentation, June 2013
Slide 1: Invion Limited (ASX:IVX) Corporate Presentation
Invion Limited (ASX:IVX) Clinical-stage life sciences company targeting chronic inflammation Corporate Presentation June | 2013
Slide 2: Disclaimer
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 investment decisions. Although
Slide 3: Invion proposition
Invion proposition > Two phase II proprietary therapeutic candidates that target chronic inflammation > INV102 (nadolol) (chronic bronchitis, asthma, cystic fibrosis) > INV103 (ala-Cpn10) (lupus) > Advancing clinical-stage company with reduced clinical risk > Experienced and well credentialed Board
Slide 4: Experienced management team
Experienced management team Greg Collier, PhD., MD and CEO > 20 year career in pharma research, development and commercialisation. CEO ChemGenex Pharmaceuticals (sold to Cephalon $230M). 150 peer reviewed publications, 33 patents, Roche Award for Excellence. Mitchell Glass, M.D., EVP R&D and CMO > 2
Slide 5: Pipeline: three phase II trials underway in 2013
Pipeline: three phase II trials underway in 2013 Preclinical Phase I Phase II INV102 (nadolol) Asthma NIH funded, US$4m+ non-dilutive funding (oral delivery) Chronic Bronchitis In patients undergoing smoking cessation (oral delivery) INV103 (ala-Cpn10) Lupus (SLE) Large unmet medical need INV102 (na
Slide 6: INV102 (nadolol)
INV102 (nadolol) • existing drug being repurposed for a new target • aim to develop an inhaled drug for the treatment of respiratory diseases including asthma and COPD • short term path to commercialisation with oral treatment of COPD
Slide 7: INV102 (nadolol)
INV102 (nadolol) > An inverse -agonist > block agonist stimulation of the receptor; AND, > inactivate intracellular inflammatory events that are stimulated spontaneously or by agonists > Current indications: high blood pressure, chest pain, migraine > Being repurposed to treat: inflammatory lung
Slide 8: Significant market opportunity
Significant market opportunity > Prescription respiratory world market $64.6B > Asthma and COPD prescription drugs $34B Respiratory world market $ > Advair Diskus ® (asthma and COPD) $8.1B > Singulair ® (asthma) $5.5B > Symbicort ® (asthma and COPD) $3.1B 21.7B 21.6B > FDA Black box warning on all L
Slide 9: INV102: Mechanism of action
INV102: Mechanism of action Airspace > Healthy lung tissue consists of Airway surface liquid mostly ciliated epithelial cells with smaller numbers of (secretory) goblet cells > In disease states the proportion of Ciliated epithelia Goblet cell goblet cells increases, lining the Smoking lung with a “
Slide 10: Mechanism of action targets multiple pathways
Mechanism of action targets multiple pathways Mucous plug > Reduction of goblet cell metaplasia > Reduced mucous hypersecretion > Restoration of ciliated epithelium > Reduced levels of pro-inflammatory cytokines: IL-5, IL-10, IL-13 Healing INV102 > Down-regulation of bronchoconstriction: Airspace >
Slide 11: Preclinical studies demonstrate airway healing
Preclinical studies demonstrate airway healing 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 on restored epithelium alprenolol Proof of c
Slide 12: Successfully completed two phase II clinical trials
Successfully completed two phase II clinical trials Objective: Proof-of-concept to evaluate safety and effects on airway with escalating doses administered to 19 subjects with mild asthma Primary endpoint: Objective measure of airway hyper- responsiveness (PC20 MeChFEV1), the diagnostic hallmark of
Slide 13: INV102: Clinical strategy
INV102: Clinical strategy Oral programs support development of inhaled product Preclinical Phase I Phase II Oral program Asthma NIH funded, US$4m+ non-dilutive funding Chronic Bronchitis In patients undergoing smoking cessation Inhaled program Chronic bronchitis Oral data supports strategy Cystic fi
Slide 14: Medical, regulatory and commercial precedent
Medical, regulatory and commercial precedent 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 (1998) $40m all class
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 Trial design Double-blinded, randomised, placebo-controlled Patients 130 (65 per arm: 54 needed for analysis) Timing Start Q2 2013 Initial data Q4 2013 Inclusion crit
Slide 16: INV102: phase II trial design – mild asthma
INV102: phase II trial design – mild asthma Trial name INV102 (nadolol) in mild asthma (NIMA) Trial design Double-blinded, randomised, placebo-controlled, multi-centre Patients 60 subjects (30 subjects in each of two treatment arms) Timing Start Q1 2013 Finish 2015 Inclusion criteria Mild asthma: on
Slide 17: INV102: phase II milestones
INV102: phase II milestones Asthma > An NIH funded phase II study ($4.4 million non-dilutive funds) was initiated Q1 2013 > Initial data obtained Q1 2014 on airway histology and sputum biomarkers > Completed phase II data anticipated 2015 > Target outcomes: improve airway hyper-responsiveness, reduc
Slide 18: INV103 (ala-Cpn10)
INV103 (ala-Cpn10) • modified natural human protein targeting inflammatory disease • demonstrated anti-inflammatory and immunoregulatory activity in multiple indications • strong safety profile
Slide 19: INV103 (ala-Cpn10)
INV103 (ala-Cpn10) > Modified version of human Chaperonin 10 > Cpn10 has demonstrated anti-inflammatory and immuno-regulatory activity in a variety of contexts > Activity ideally suited to the treatment of inflammation associated with autoimmune disease > Data to date > Dose response reduction in bi
Slide 20: Significant market opportunity
Significant market opportunity > March 2011 FDA approved the first new drug for lupus in more than 50 years > Reflection of the complexity of the disease > Clear indication of a major unmet clinical need > Forecast: sales of over $4B in the US and five major EU markets by 2020 Lupus market size ($mi
Slide 21: INV103: Mechanism of action
INV103: Mechanism of action > Chaperonins play roles unrelated to protein folding, incl. interplay with cells involved in the innate and adaptive immune responses > Expression of Cpn10 is up-regulated in response to inflammation and can be measured extra-cellularly > Cpn10 has demonstrated anti-infl
Slide 22: INV103: Pre-clinical results in lupus models
INV103: Pre-clinical results in lupus models > Strong pre-clinical data in lupus animal model (3 studies) > significantly reduced kidney pathology > improved survival > prevented cutaneous lupus > reduced renal and circulating levels of key pro-inflammatory mediators (TNF-α, IL-6 and MCP-1) reduced
Slide 23: INV103: Phase II clinical strategy
INV103: Phase II clinical strategy Systemic lupus erythematosus (SLE or lupus) > Lupus is a vascular inflammatory disease > IL-6 is a marker of vascular inflammation > INV103 has a significant effect on IL-6 > Pre-IND meeting with US FDA Dec 12 > FDA confirmed lupus as important unmet clinical need
Slide 24: INV103: Phase II trial design – SLE
INV103: Phase II trial design – SLE Trial name INV103 (ala-Cpn10) in mildly active Systemic Lupus Erythematosus (SLE) Trial design Double-blinded, randomized, placebo-controlled, intravenous dosing Patients 32 subjects (8 subjects per dose cohort, 4 cohorts) Timing Start Q2 1013 Initial data Q4 2013
Slide 25: INV103: Phase II milestones
INV103: Phase II milestones Lupus > Q4 2013 completion of 1 or 2 cohorts: biochemical evidence of efficacy; safety of increased doses > Driver for scale manufacture of ala-CPN10 > Driver for full scale dose ranging in Lupus > Optional: proof of concept in psoriasis with higher doses from first study
Slide 26: Summary
Summary 2 drug assets 3 FDA-regulated phase II clinical trials experienced management team significant valuation drivers: 12-36 months
Slide 27: Pipeline: three phase II trials underway in 2013
Pipeline: three phase II trials underway in 2013 Preclinical Phase I Phase II INV102 (nadolol) Asthma NIH funded, US$4m+ non-dilutive funding (oral delivery) Chronic Bronchitis In patients undergoing smoking cessation (oral delivery) INV103 (ala-Cpn10) Lupus (SLE) Large unmet medical need, 1 FDA app
Slide 28: Milestones to watch
Milestones to watch 2013 Q1 Asthma - phase II study in asthma initiated, enrollments and patient dosing underway Lupus - IND filed with FDA Q2 > Lupus - initiation of clinical trial and first patients dosed Q3 > Chronic bronchitis (smoking cessation) - initiation of phase II study > Asthma - enr
Slide 29: Summary
Summary 2 drug candidates targeting chronic inflammatory diseases − INV102 (nadolol) − INV103 (ala-Cpn10) 3 FDA-regulated phase II programs underway in 2013 − asthma − chronic bronchitis (smoking cessation) − lupus Large and growing markets Data to support strategy − medical, regulatory, commercial
Slide 30: Corporate snapshot
Corporate snapshot Sector Life Sciences (Biotechnology) Principal activities Clinical-stage pharmaceutical drug development Pipeline 2 drug candidates in 3 phase II clinical programs Operations USA & Australia ASX code IVX Share price (31 May 2013) $0.041 (4.1 cents) Shares on issue ~409.4M Options
Slide 31: Invion Limited contact details
Invion Limited Managing Director and CEO 2/120 Bluestone Circuit Dr Greg Collier Seventeen Mile Rocks [email protected] QLD 4073 Australia P: +61 7 3295 0500 Investor and Media Relations F: +61 7 3295 0599 Buchan Consulting W: www.invion.com.au [email protected] [email protected] Cont