AGM Presentation
Released
Released
Announcement PDF
ANNUAL GENERAL
MEETING
November 2024
ASX: IVX
Next Generation Photodynamic Therapy (PDT)
for Cancers and Infectious Diseases
DISCLAIMER
The information in this presentation does not constitute personal investment
advice. The presentation is not intended to be comprehensive or provide
all information required by investors to make an informed decision on any
investment in Invion Limited (Company). In preparing this presentation, the
Company did not take into account the investment objectives, financial
situation and particular needs of any particular investor. Further advice
should be obtained from a professional investment adviser before taking
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written or otherwise, contained or referred to in this presentation.
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2
YEAR OF ACHIEVEMENTS
PROGRESSING TOWARDS KEY CLINICAL MILESTONES
Patient Recruitment for Ph I/II
Non-Melanoma Skin Cancer
Trial
Successful Ph 2 Prostate
Cancer Clinical Trial Results
Collaboration Hanlim Pharm:
Glioblastoma (Preclinical)
Combination INV043 + ICI
Immunotherapy in ASCC: 80% Tumour
Control (vs 12% standalone)
Partnership Dr.inB to Develop
Photosoft for HPV (PoC
Clinical Trials)
GMP Manufacture
INV043 by IDT
Australian Patent
Granted
FY
24
3
FY
25
TARGET DISEASES AND INDICATIONS
PDT FOR TREATMENT OF CANCERS AND INFECTIOUS DISEASES*
PRIMARY FOCUS: CANCER (INV043)
Multiple cancer indications
Ablation and activation of immune response
Improved efficacy of immune checkpoint
inhibitor (ICI) treatments when in combination
Topical and systemic formulations
Strong therapeutic profile
4
INFECTIOUS DISEASES
Broad spectrum antimicrobial activity
against viruses, bacteria and fungi
No known drug resistance (to address
AMR)
Commercially viable focus
Target Indications
Target Indications
Non-melanoma skin cancer (topical)
Prostate cancer (sublingual)
Anogenital cancer (topical)
Glioblastoma (GBM): studies
undertaken and funded by Hanlim
Pharma
Solid tumour cancer TBD (IV)
Human Papilloma Virus (HPV):
studies undertaken and funded
by Dr.inB
Oral antimicrobial: peri-implant
mucositis
Additional TBD
*Core Australian cancer development fully funded by RMW Cho Group, inventor/owner of Photosoft. Invion has exclusive rights to Photosoft in
Asia and Oceania, including Australia and New Zealand (ANZ), but excluding the specified territories of China, Macau and Taiwan. The USA and
Canada are included for Infectious Disease Indications. Invion co-contributes 25% pre-clinical & 75% clinical costs outside of ANZ.
RESULTS AND FINDINGS:
CANCER
Clinical & Preclinical Data
PHASE II PROSTATE CANCER CLINICAL TRIAL
INVESTIGATOR-LED PROSTATE CANCER STUDY USING INV043*
Screening: Men between 50-80 years with
Biopsy proven primary prostate cancer, or
Primary prostate cancer diagnosed by
PSMA-PET or MRI.
75 Patients
originally
planned
PATIENT PROFILE
Patient Profile
• Primary or relapsed
• Primary or relapsed
localised prostate
localised prostate
cancer (diagnosed via
cancer (diagnosed via
biopsy or PSMA-PET)
biopsy or PSMA-PET)
• Ages: 50-70
• Ages: 50-70 (mean 62.5)
(mean 62.5)
• Gleason Scores: 6-9
• Baseline Gleason
(mean 6.9)
Scores: 6-9 (mean 6.9)
6
1st cohort of
25 patients
enrolled
41 Patients
enrolled
(due to COVID19 disruptions)
2nd cohort of
16 patients
treated postCOVID
COVID-19 Lockdowns: 10 patients
dropped out. Remaining treated
but with inconsistent compliance
and data collection
Only data
from 2nd
cohort used
PRIMARY ENDPOINT
TREATMENT PROTOCOL
INV043 PDT treatment effectiveness
using Response Evaluation Criteria in
Solid Tumours (RECIST 1.1)
Each patient had 6 cycles of PDT treatment
over 9 weeks (2 x PDT cycles over
consecutive days, then four-week interval)
SECONDARY ENDPOINTS
To assess safety and tolerability as well
as further assessments on effectiveness
using standard outcome measures
* RMW Cho Group funded study as previously disclosed to the market
Each PDT cycle consisted of 2 steps.
Step 1: Sublingual administration of
photosensitiser
Step 2: ~15-20 hours after dosing, 25 min of
660 nm laser administered
PHASE II PROSTATE TRIAL RESULTS: SUBLINGUAL (SYSTEMIC)
COMPELLING SAFETY, SOLID EFFICACY SIGNALS
SAFE AND WELL TOLERATED
EFFICACY: 40-44% RESPONSE RATE
When administered sublingually to patients over 6 cycles of
PDT treatments (from 2nd cohort, n=16) over 3 months:
No serious adverse events, life-threatening treatment
emergent adverse events (TEAEs)
No clinically significant changes in vital signs, ECGs, or
laboratory parameters reported
All adverse events reported were mild
No. of Occurrences of TEAEs
In contrast, current treatment options (eg, radiotherapy,
chemotherapy and surgery) carry risks of significant side
effects such as incontinence, bowel dysfunction, erectile
#
dysfunction
and/or infertility1
8
6
Recorded Adverse Events
16 patients x 6 questionnaires = 96 recordings
During
After
4
2
PSMA-PET1 Results
Patients (Cohort 2, n-=16) evaluated using PSMA-PET scan
to detect prostate cancer:
BEFORE: All 16 patients were positive before treatment
AFTER: 7 patients negative 3 months after treatment
(~44% response), 9 patients were positive
RECIST Framework3 (Response Evaluation Criteria)
Where possible, MRI scans taken pre and post treatment
to measure lesion size in prostate (n=10) 2
40% patients had +ve response 3 mths post treatment
o
1 complete regression (no detectable lesion)
o
3 partial regression (>30% reduction in lesion size)
40% patients showed stable disease
0
20% with disease progression (>30% lesion increase)
1 PSMA PET-CT now routinely used to evaluate prostate cancer for primary staging and
7
1 https://www.pcf.org/about-prostate-cancer/prostate-cancer-side-effects/
suspected tumour recurrence (Combes AD, 2022). Employs radioactive substance that
targets PSMA (prostate-specific membrane antigen) protein expressed by prostate cancer cells.
2 Two received prostatectomy prior to PDT treatment and were excluded. Four patients did not
have MRI scans for various reasons (eg, presence of implants) and excluded from assessment.
3 https://recist.eortc.org
ONGOING PHASE I/II TRIAL: NON-MELANOMA SKIN CANCER
THERAGNOSTIC ENDPOINTS
• Adaptive: Open label adaptive trial design (3+3 light dose / dose light interval escalation1) enables
flexibility in size and timing, with option for repeat treatment depending on response
• Safety, Dose Optimization and Efficacy: Earlier parts focus more on safety and tolerability, later parts
more on dose and schedule optimization, and efficacy. Multiple treatments may be repeated for
patients
• Significant Unmet Need: Cutaneous Squamous Cell Carcinoma (cSCC) and superficial Basal Cell
Carcinoma (sBCC), 98% of all skin cancers – one of the world’s most common cancers
Part 3
Part 2
Part 1
Light Dose, 3+3
Dose-Escalation
Dose Light Interval
Optimisation
(Optional)
Dose Expansion
ENDPOINTS
Safety and tolerability including
Dose Limiting toxicity (DLT)
Dose optimization: Light dose, dose
light interval investigations
Anti-tumour activity
Diagnostic via fluorescence
Pharmacodynamic investigations
Ongoing screening and recruitment in Australia for NMSC trial using topical formulation
1 In a “3+3 design,” three patients are initially enrolled into a given dose cohort. If there is no DLT (dose limiting toxicity) observed in any of these subjects,
the trial proceeds to enroll additional subjects into the next higher dose cohort.
WHY SKIN CANCER?
ATTRACTIVE CLINICAL TRIAL INDICATION
Relatively Cost Effective
Costs to undertake skin cancer trials typically lower than for
other routes of administration (eg, intravenous)
Faster Path to Market
Trials with topical treatments often quicker to complete due to
fewer safety concerns and effects can be more readily observed
Synergies with Other Studies
Safety data from same topical formulation may enable a
faster path to a Phase II trial for anogenital cancers
Large Attractive Market
One of the world’s most common cancers with the skin cancer
treatment market expected to hit US$18.1B in 2030 (7.7% CAGR1)
Unmet Medical Need
NMSC comprise 98% of all skin cancers and deaths exceed
melanoma globally2 Standard of care can result in scarring and pain
9
1 https://finance.yahoo.com/news/skin-cancer-treatment-market-surpass-130500291.html
2 GLOBOCON 2020, WHO
EVALUATION OF NMSC THERAPIES1
POTENTIAL TO DISPLACE STANDARD OF CARE
Non-Melanoma Skin Cancer (NMSC) Phase I/II Clinical Trial (Adaptive Trial Structure):
Addressing the unmet need for one of the world’s most common cancers2
GOOD
INV043
(Topical)
Metvix#/ALA
PDT Treatment
COSMETIC
RESULT
#by Galderma S.A.
Cryosurgery
Curettage &
Electrodesiccation
Excisional
Surgery
POOR
FAIR
1 Based on management views
10
Mohs
Surgery
EFFECTIVENESS
* https://www.aad.org/news/guidelines-to-treat-nonmelanoma-skin-cancer
* https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5746716/
* https://amp.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html
2 https://amp.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html
GOOD
Less Pain/
Discomfort
More Pain/
Discomfort)
TREATMENT OPTIONS: FLEXIBILITY FOR CLINICIANS
MULTIPLE PATHWAYS FOR DRUG AND TARGETED LIGHT DELIVERY
INV043 can be administered to multiple target indications via different drug and light delivery options
ROUTES OF DRUG ADMINISTRATION
11
TOPICAL
INTRAVENOUS
INTRATUMORAL
SUBLINGUAL
LIGHT ADMINISTRATION OPTIONS
TOPICALLY (LASER/LED)
WITH OPEN SURGERY
ENDOSCOPICALLY
KEYHOLE SURGERY
MULTIPLE
POTENTIAL TARGETS
THERAGNOSTIC POTENTIAL
MULTIPLE CANCERS, PRECISION CANCER TARGETING, PROTECTIVE IMMUNITY
SELECTIVE TARGETING
Treated
Control
PROTECTIVE IMMUNITY
https://inviongroup.com/videos-reports/
• INV043 selectively retained in malignant but not healthy
tissue, across multiple cancers (incl. pancreatic, triplenegative breast, T-cell lymphoma in vivo)
• Triple Negative Breast Cancer (TNBC) is a hard-to-treat
cancer resistant to most chemotherapies
• Minimises collateral damage to healthy organ tissues
with no notable toxicity issues
• Hudson Institute proof-of-concept (PoC) pilot showed
complete regression of TNBC in vivo following INV043
treatment
• INV043 has both fluorescence as well as ablation
characteristics (under different wavelengths of light)
• Tumour mass undetectable two weeks after initial
treatment and no scarring evident
• Applications in both diagnostic (405nm) and
therapeutic use (660nm) – theragnostic potential
• No recurrence of disease, re-challenge with TNBC
implant could not re-establish new tumours, suggesting
development of protective immunity
12
1 Adapted from https://www.nature.com/articles/s41598-023-30256-0#citeas, using chlorin e6 photosensitizer.
The research activities involving the use of animals were carried out in accordance with relevant guidelines and regulations as well as with
appropriate Animal Ethics Committee approval.
COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS (ICI)
IMPROVING IMMUNOTHERAPY OUTCOMES, PARTNERSHIP POTENTIAL
•
Immune checkpoint inhibitors (ICI), a type of immunotherapy, is standard of care in treatment of several cancers
•
Despite widespread use of ICIs, the patient response rate can be as low as 12.5%1
•
Independent in vivo studies showed combined INV043 and anti-PD-1 therapies achieved 80% tumour elimination
HUDSON INSTITUTE:. ~65% IMPROVEMENT IN TUMOUR VOLUME
(TRIPLE NEGATIVE BREAST CANCER, INTRATUMORAL)2
PETER MAC: ~80% RESPONSE RATE
(ANAL SCC CANCER, TOPICAL)3
4T1 breast tumours treated using a restricted INV043 PDT protocol
(intratumoural) and / or anti PD-1 antibody (intratumoral)
Anal Squamous Cell Carcinoma (ASCC) tumours treated using a
restricted INV043 PDT protocol (topical) and / or anti PD-1 antibody
Monotherapies restricted tumour growth vs untreated controls
Monotherapies restricted tumour growth vs untreated controls, with
standalone INV043 showing lower tumour volume vs ICI alone
Combination therapy regressed and stabilized tumours and achieved
a ~65% reduction in tumour size at endpoint (n=4/group)
Combination therapy resulted in 80% tumour-free subjective at
endpoint (n=8-10/group)
7/10, no measurable tumour.
8th mouse histology, no
evidence of tumour cells
**
Combi therapy:
~65% improvement
in effectiveness vs.
ICI alone
*
*** INV043+PD1 vs Vehicle = p=0.001
** INV043+PD1 vs PD1 p=0.0037
* INV043 vs Vehicle p=0.0397
13
1 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2762389
2 https://announcements.asx.com.au/asxpdf/20220530/pdf/459ffkjbvdpjrg.pdf
3 Per ASX announcement 4 March 2024
***
CREATING IMPACT FOR TREATING CANCERS GLOBALLY
NEED FOR MORE AFFORDABLE NEW TREATMENTS
Cost of new FDA drugs in
2023 jumped 35% YoY at
median price of US$300K1,
making affordability even
harder for the majority of
the world’s patients.
Trends towards personalised
medicines and targeted
therapies (e.g. CAR T / cell
therapies, immunotherapies,
antibody drug conjugates
which can cost US$100-500k2),
Half of new drugs are orphan3,
which cost 5.5 times more than
non-orphan4
Commercial Rationale for Photosoft
Works across multiple cancers without need
to personalise – precision with less complexity
INV043 is a small molecule based therapy
that is highly scalable
Photosoft solution has lower development
and manufacturing costs
Equipment and treatment process is not
complex - helps reach a larger patient base
1 https://www.reuters.com/business/healthcare-pharmaceuticals/prices-new-us-drugs-rose-35-2023-more-than-previous-year-2024-02-23/
14
2 https://www.mdpi.com/1999-4923/15/6/1761#:~:text=Additionally%2C%20the%20cost%20of%20ADC,a%20barrier%20for%20some%20patients
3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10290406/#:~:text=There%20has%20been%20significant%20policy,being%20approved%20in%20recent%20years
4 https://www.mdpi.com/1999-4923/15/6/1761#:~:text=Additionally%2C%20the%20cost%20of%20ADC,a%20barrier%20for%20some%20patients
TARGET INDICATIONS AND TIMEFRAMES
MULTIPLE CLINICAL TRIALS AND INDICATIONS
DISEASE AREA (CALENDAR YEAR)
1H2024
2H2024
1H2025
2H2025
>CY26
CANCER1
Prostate Cancer (Funded by RMWC)
Completed
Follow up and monitoring
Adaptive study design
Non-Melanoma Skin Cancers (Topical)2
Anogenital Cancers (Topical)
Glioblastoma (Funded by Hanlim)
INFECTIOUS DISEASES
HPV (Funded by Dr.inB)
Oral Microbial (Peri-Implant Mucositis)3
PreClinical
15
Phase 1
Phase 1b/2
1 Cancer is the key area of focus for Invion
2 The Phase I/II NMSC trial uses an adaptive study design means recruitment numbers and timelines may change to accelerate the evaluation of INV043
3 Timing subject to ongoing dialog with US FDA to determine pre-clinical requirements
INFECTIOUS DISEASES
Additional Commercialisation Opportunities
BROAD-SPECTRUM ANTI-MICROBIAL POTENTIAL
ANTI-MICROBIAL TREATMENTS – WITHOUT RESISTANCE
“Antimicrobial resistance (AMR) is one of the top 10 threats facing humanity”
World Health Organisation1
Leading Institutions: Viroclinics conducted virus
tests & ACARE (University of Adelaide) conducted
bacteria and fungi tests
100
% Inhibition
Broad Spectrum Potential: In vitro tests showed
PhotosoftTM to be effective against several types of
pathogens, including antibiotic-resistant superbugs
SARS-CoV-2: Omicron
Selected PhotosoftTM Compounds vs. Remdesivir
PhotosoftTM compounds
80
60
40
20
Remdesivir
0
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Concentration µM
Need for New Treatment Options: Potential for
PhotosoftTM as a new treatment class for
polymicrobial infections and/or where pathogens
cannot develop drug resistance
30
Broad Spectrum Activity: Minimum Inhibition
Concentration (MIC50) of Selected Photosoft Compound
following exposure to light for 5 minutes
25
F1642 MIC
Candida albicans VDL-
90028 MIC
Candida albicans ATCC
ATCC 35218) MIC
Gram-negative (E. coli
ATCC 25922) MIC
Gram-negative (E. coli
1 https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
0
43300) [MRSA] MIC
17
”
5
Gram-positive (ATCC
Prof Darren J. Trott, Director, Australian Centre for Antimicrobial Resistance Ecology
(ACARE), University of Adelaide
10
[MRSA] MIC
Given the general mode of action of PDT… it is unlikely
for superbugs to develop resistance to the compounds
15
Gram-positive (USA300)
“
µM
20
1
TARGET ANTIMICROBIAL INDICATIONS
COST EFFECTIVE AND ACCELERATED PATHS TO CLINICAL TRIALS
HPV PROGRAM FUNDED BY DR.INB
PERIODONTAL DISEASE
HPV distribution profile in women 1
57.7%
44.4%
42.2%
21.4%
3.7%
Eastern Asia
Central & Sub-Saharan
Southern
Africa
Asia
Eastern
Europe
Western
Europe
Collaboration
Addressing a Growing Unmet Need
• Per CDC, 47.2% in US >30 years, have a form of
periodontal disease, increasing 70.1% of those >65 years2
• Undertake and fund to Proof-of-Concept clinical trials to test • Global periodontal market size US$ 9.1 billion in 2022, to
reach ~US$ 24.4 billion by 20323
patient safety and efficacy (using different PhotosoftTM
photosensitizer than INV043)
• 28-56% of implant patients develop peri-implantitis4, an
inflammatory reaction, with loss of supporting bone
• Dr.inB is a leading developer of PDT treatments in South
around an implant
Korea backed by Hanlim Pharma. Co., Ltd.
• Collaboration provides accelerated pathway to
demonstrate clinical potential of Photosoft in infectious
diseases like HPV
• PhotosoftTM PDT advantages
• Invion retains all rights to Photosoft and any new IP
18
1 https://www.sciencedirect.com/science/article/abs/pii/S0264410X12010808
2 https://www.cdc.gov/oralhealth/conditions/periodontal-disease.html
3 https://www.futuremarketinsights.com/reports/periodontal-
market#:~:text=Periodontal%20Market%20Size%20%2D%20Industry%20Outlook,billion%20by%20the%20year%202032
4 https://pubmed.ncbi.nlm.nih.gov/18724856/ and Carl E. Misch 4th Edition
• No resistance development
• Non-invasive treatment
• Ease of application
• Repeated treatment possible
EXPERIENCED TEAM
THE RIGHT EXPERTISE FOR SUCCESS
PROF THIAN CHEW
EXECUTIVE CHAIRMAN & CEO
SCOTT CARPENTER
PROGRAM DIRECTOR
• Co-Founder, Chronic Airway Therapeutics
• Advisory Board, Stanford Medicine CARE
• Executive Director, Goldman Sachs
• Director, KPMG Consulting, Senior Manager KPMG
• Adj. Prof. HKUST, MBA/MA Wharton School
• Director Business Development, Starpharma
• Program Manager, AusBiotech
• Regulatory Affairs, Bayer CropScience
• MBA Melb Business School, B. Applied Science RMIT
DR AMY PRAWIRA
MEDICAL CONSULTANT
DR SOUMYA RAI
PROGRAM MANAGER
• Founder/CEO, Obatica Pty Ltd (engaged to assist with clinical trials)
• Dental surgeon, clinical and business mgmt experience
• 12+ years in clinical oncology and trials
• Resident, JLN House and Research Centre, SAIL
• Investigator with experience in over 90 early phase clinical trials
• Asst Prof. Rungta College Dental Sciences and Research
• Head, Cancer Trials and Research Unit, Prince of Wales Hospital
(Sydney)
• MBA HKUST
KIM STEEL
CLINICAL TRIAL MANAGEMENT
PROF SEBASTIAN MARCUCCIO
MEDICINAL CHEMISTRY
• 18+ years managing global and clinical drug and
device studies from Phase 1-IV across 14 countries
• 35+ years in pharmaceutical/organic chemistry drug discovery
and development (co-inventor recent PDT patents)
• Managing Director, SAPRO Consulting
• Founder / Director Advanced Molecular Technologies
• Project Director, Novotech
• Previously in Pharmaceutical Chemicals Research, CSIRO
• Project Manager, Pacific Clinical Research Group
• Adj. Prof. La Trobe University, PhD Organic Chemistry ANU
ALEXANDER BENNETT
TECHNICAL ADVISOR, LIGHT DEVICES
LOUISE WHITE
MANUFACTURING AND QUALITY
• 35+ years in R&D, manufacturing and commercialisation of
scientific instrumentation incl. ISO certifications
• GM Forensic Light Sources, Rofin Australia.
19
• Led Medical Light Source trial for PDT in skin cancers Peter
MacCallum Cancer Centre
• 35+ years in the pharmaceutical industry, 13 years in vaccine
manufacturing, CSL, Partner SeerPharma
• Experience in virology R&D, bacterial vaccines production,
quality control and production planning
• Registered auditor for APVMA
Sign up at Invion’s Investor Hub to receive regular updates, provide feedback and
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For more information, go to www.inviongroup.com
Investor and Media enquiries:
Thian Chew (Chairman & CEO)
T: +61 3 9692 7222
E: investor@inviongroup.com
Brendon Lau (Investor & Media Relations)
M: +61 409 341 613
E: brendon.lau@inviongroup.com
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