Adalta Ltd. · ASX:1AD
Adalta — Corporate Update (March 2021)
35 slides from Adalta's corporate update, Mar 10, 2021
Slide 1: AD-214 Phase I study: positive data expands opportunities for AdAlta
10 March 2021 ASX Announcement For personal use only AD-214 Phase I study: positive data expands opportunities for AdAlta MELBOURNE Australia, 10 March 2021: AdAlta Limited (ASX:1AD), a clinical stage biopharmaceutical discovery and development company using i-body technology to address challenging
Slide 2: Notes to Editors: About AdAlta
Notes to Editors About AdAlta AdAlta Limited is a clinical stage drug development company headquartered in Melbourne, Australia. The Company is using its proprietary i-body technology platform For personal use only to solve challenging drug targeting problems and generate a promising new class of si
Slide 3: AD-214 Phase I study: positive data expands opportunity
For personal use only AD-214 Phase I study: positive data expands opportunity Investor Briefing 10 March 2021 AdAlta Limited (ASX:1AD) enquiries@adalta.com.au
Slide 4: Disclaimer
Disclaimer For personal use only Investment in AdAlta is subject to investment risk, including possible loss of income and capital invested. AdAlta does not guarantee any particular rate of return or performance, nor do they guarantee the repayment of capital. This presentation is not an offer or in
Slide 5: Agenda today
Agenda today For personal use only Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Old
Slide 6: Today's highlights
Today’s highlights ü Single ascending dose (SAD) healthy volunteer (HV) study successfully completed For personal use only ü AD-214 is very well tolerated in single doses to 20 mg/kg in healthy volunteers ü AD-214 engages its target receptor, CXCR4, and sustains high levels of receptor occupancy Ø R
Slide 7: Agenda today
Agenda today For personal use only Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Old
Slide 8: AdAlta is rapidly transforming to a multi-asset company
AdAlta is rapidly transforming to a multi-asset company For personal use only 4 Executing growth: creating multiple i-body-enabled assets $8m • • $8.1 million raised Sep 2020 in placement and rights issue Progressing new internal product ideas: 2 programs to start 2021 • Encouraging business develop
Slide 9: AdAlta has two strategies to create valuable assets from the i-body platform
AdAlta has two strategies to create valuable assets from the i-body platform For personal use only A In-house pipeline of Licence to pharma drug candidates Major upfronts + milestones Usually GPCRs in fibrosis, & royalties inflammation, oncology Invest to value inflection A B G (typically Phase I or
Slide 10: Near term strategic priorities set March 2020
Near term strategic priorities set March 2020 For personal use only Create value inflections for lead asset AD-214 • Clinical development in IPF/ILD • Expand indications, create licensing options Add 2 assets to internal pipeline in our “sweet spot” • G-protein coupled receptors (GPCRs) • Fibrosis,
Slide 11: Strategic priorities: progress to March 2021
Strategic priorities: progress to March 2021 March 2021 status For personal use only • Phase I clinical program started: top-line single dose results today Create value inflections for • Pre-IND meeting and Orphan Drug Designation secured from FDA lead asset AD-214 • Pre-clinical data in kidney fibr
Slide 12: Major milestones achieved since March 2020
Major milestones achieved since March 2020 Mar ‘21 For personal use only Safety, PK, RO FDA pre-IND Ph I Part A Ph I part A in NHP advice safety update top line safety AD-214 Efficacy in BLM Ph I Part A FDA ODD mouse commenced in IPF Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2020 2021 Other assets Growth $8.1m strate
Slide 13: FDA engagement: AD-214
FDA engagement: AD-214 For personal use only Pre-IND meeting June 2020 Orphan Drug Designation granted for AD-214 in IPF February 2021 • Pre-clinical studies “generally sufficient” to support an IND application • Phase I trial design is “reasonable” • Minor feedback readily incorporated into clinica
Slide 14: Agenda today
Agenda today For personal use only Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Old
Slide 15: Preliminary healthy volunteer single dose results
Preliminary healthy volunteer single dose results For personal use only AD-214 has an excellent safety profile D sta atab tist ase ica • No dose limiting toxicities or adverse events of clinical concern l an lock aly and • No concerning clinical laboratory results sis pen full • Consistent with Non-
Slide 16: AD-214 Phase I Part A design detail
AD-214 Phase I Part A design detail* Phase I, dose-escalating study of the safety, tolerability, PK and PD of single and repeat doses of AD-214 in For personal use only healthy volunteers (HVs) and patients with interstitial lung disease (ILD) Part A: Single ascending dose in healthy volunteers Obje
Slide 17: Single dose of AD-214 is well tolerated
Single dose of AD-214 is well tolerated For personal use only Adverse events (unblinded data) Immune response* • No dose limiting adverse events • Isolated incidences of minor cytokine elevation - Transient and primarily low level elevation of IL-6 and IL-8 in some participants (including placebos)
Slide 18: AD-214 pharmacokinetics increase proportionally with dose
AD-214 pharmacokinetics increase proportionally with dose For personal use only Observed in NHP GLP toxicology study Observed in Phase I HV SAD Maximum exposure, Cmax, increases in a dose Maximum exposure, Cmax, increases in a dose proportional manner proportional manner Total exposure, AUC0-inf, in
Slide 19: Transient white blood cell and blood stem cell increases indicate CXCR4 engagement
Transient white blood cell and blood stem cell increases indicate CXCR4 engagement For personal use only Observed in NHP GLP toxicology Observed in Phase I HV SAD* Transient increase in white cell counts (WCC) and Transient, dose dependent, increase in WCC and blood stem cell (CD34+) cell counts CD3
Slide 20: Transient increase in SDF-1 suggests CXCR4 engagement
Transient increase in SDF-1 (natural ligand of CXCR4) suggests CXCR4 engagement For personal use only Expected from literature and prior studies Observed in Phase I HV SAD* Transient increases in SDF-1 levels in response to Transient increases in SDF-1 levels at 4 hours in CXCR4 blockade, high parti
Slide 21: Sustained high levels of CXCR4 receptor occupancy on T cells
Sustained high levels of CXCR4 receptor occupancy on T cells For personal use only Mean occupancy of T cell CXCR4 receptors by White blood cells naturally express CXCR4 in healthy AD-214 0.01mg/kg individuals, providing an accessible surrogate for AD-214 target 120 engagement or receptor occupancy (
Slide 22: More efficient design for remainder of Phase I
More efficient design for remainder of Phase I For personal use only Current approved Phase 1 protocol ✓ Part A: HV SAD Part B: IPF/ILD SAD Part C: IPF/ILD MAD Blinded/placebo controlled Unblinded/no placebo Unblinded/no placebo 7 cohorts 5 cohorts 4 cohorts / once weekly dosing Up to 44 pts 15 – 30
Slide 23: Agenda today
Agenda today For personal use only Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Old
Slide 24: Lead indication IPF: $3b market, poor options
Lead indication IPF: $3b market, poor options Idiopathic Pulmonary Fibrosis For personal use only (IPF) is irreversible, unpredictable, incurable >300,000 people living with IPF 40,000 people die from IPF every year 3.8 years median survival after diagnosis Current treatments come with safety, effic
Slide 25: Limited (and decreasing) new options for patients
Limited (and decreasing) new options for patients FDA Fast FDA Orphan For personal use only Phase II Phase III Track Drug ISABELA 1&2: TERMINATED GLPG1690 12 weeks, 23 subjects 52 weeks, 1500 subjects ✓ ZEPHYRUS - ACTIVE Pamrevlumab 48 weeks, 103 subjects 52 weeks, 565 subjects ✓ ✓ NO PROGRESS SINCE
Slide 26: CXCR4: Role in IPF
CXCR4: Role in IPF CXCR4 plays a role in IPF CXCR4 CXCR4 is upregulated in IPF Very limited expression in For personal use only lung tissue normal or non-diseased tissues Normal lung histology Brown stain shows amount of CXCR4 24
Slide 27: CXCR4 is expressed in both IPF and ILD patient lung tissue
CXCR4 is expressed in both IPF and ILD patient lung tissue and in multiple cell types For personal use only CXCR4 was abundantly expressed in both IPF and ILF donors compared with non-diseased controls CXCR4 is expressed on circulating immune cells and we have demonstrated that in patients with IPF
Slide 28: Why targeting CXCR4 could improve IPF/ILD outcomes
Why targeting CXCR4 could improve IPF/ILD outcomes For personal use only Observation Significance CXCR4 is up-regulated in ILD patients as well If AD-214 works in IPF it is more likely to work as IPF patients in ILD as well … and there are at least as many non-IPF ILD patients as IPF patients CXCR4
Slide 29: Implications for AD-214: a clinician's perspective
Implications for AD-214: a clinician’s perspective For personal use only Un-met need in IPF/ILD remains: need to progress new therapies Research at The Alfred suggests that if targeting CXCR4 works in IPF it may also work in other ILD’s AD-214 is well tolerated and ready to move forward into multi-d
Slide 30: Agenda today
Agenda today For personal use only Strategic progress Tim Oldham, CEO and Managing Director AD-214 Phase I HV SAD top-line results Claudia Gregorio-King, VP Clinical Product Development Context: importance for IPF Prof Glen Westall, leading respiratory and lung fibrosis specialist Next steps Tim Old
Slide 31: Advantages of amended Phase I design
Advantages of amended Phase I design For personal use only • Early data on effect of elevated CXCR4 on AD-214 distribution and receptor occupancy in Preserves diseased tissue remains on track for Q3 2021 original • Explores potential for longer dosing intervals objectives • Provides insight to mode
Slide 32: Clinical validation of i-body platform unlocks pipeline expansion opportunities
Clinical validation of i-body platform unlocks pipeline expansion opportunities For personal use only November 2019 November 2020 End 2021 (est) End 2023 (aim) Preclinical, IND Class of Partner Product/ Indication Discovery product enabling Phase I Phase II Target Target dev studies Internal pipelin
Slide 33: Milestones for remainder of 2021
Milestones for remainder of 2021 Mar ‘21 For personal use only Phase Ib Safety, PK, RO FDA pre-IND Ph I Part A Ph I HV SAD commences 1st partnering in NHP advice safety update top line safety 1st PET images window opens AD-214 Efficacy in BLM Ph I Part A FDA ODD PET tracer Ph I HV MAD Ph I HV MAD mo
Slide 34: AdAlta (ASX:1AD) investment proposition
AdAlta (ASX:1AD) investment proposition Molecular Imaging with CXCR4-Gallium-68-Pentixa correlates with GAP Index and Treatment Effects i Antje Prasse1, Danny Jonigk2, Tobias Welte1, Benedikt Jäger1, Frank B 1Pneumology, Hannover Medical School; Fraunhofer ITEM, DZL BREAT 2Pathology, Hannover Medica
Slide 35: Contacts for more information
For personal use only Contacts for more information: Tim Oldham, CEO and Managing Director enquiries@adalta.com.au www.adalta.com.au