Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Non-Deal Roadshow (October 2024)
37 slides from Arovella Therapeutics's roadshow presentation, Oct 16, 2024
Slide 1: Investor Presentation ASX Release
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 16 October 2024 INVESTOR PRESENTATION MELBOURNE, AUSTRALIA 16 October 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased t
Slide 2: Notes to Editors: About Arovella Therapeutics
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 NOTES TO EDITORS: About Arovella Therapeutics Ltd Arovella Therapeutics Ltd (ASX: ALA) is a biotechnology company focused on developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cance
Slide 3: Investor Lunch October 2024
ASX:ALA For personal use only Investor Lunch October 2024
Slide 4: Disclaimer
Disclaimer 1. The information in this presentation does not constitute personal investment 4. Whilst this presentation is based on information from sources which are advice. The presentation is not intended to be comprehensive or provide all considered reliable, no representation or warranty, expres
Slide 5: Arovella's strengths
Arovella’s strengths Off-the-Shelf iNKT Lead Product Addressing Key Strong For personal use only Cell Platform Advancing to Clinic Unmet Need Leadership Group Developing off-the-shelf iNKT ALA-101, potential treatment Our iNKT cell platform is Leadership team and Board cell therapies to target blood
Slide 6: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA $0.20 For personal use only Market capitalisation1 $194.59 million 40,000,000 $0.18 Shares on issue 1,051.8 million $0.16 52-week low / high1 $0.074 / $0.190 $0.14 30,000,000 Cash Balance (30 June 30, 2024) $12.7 mi
Slide 7: Recent cell therapy transactions
Recent cell therapy transactions1 Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage (US$M) (US$M) value (US$M) Research May-24 T cell TBD $50 $550 $600 collaboration For personal use only Dec-23 Acquisition T Cell Phase 1b $1,000 $200 $1,200 Collaborat
Slide 8: About CAR-T cells
For personal use only About CAR-T cells 6
Slide 9: How original CAR-T cell therapies work
How original CAR-T cell therapies work CAR-T cell therapy is personalised medicine T cells = immune cell For personal use only - T cells are a common type of immune cell that fight infections and can help fight cancer. T cells from patient ‘reprogrammed’ - - To generate autologous CAR-T cells, T cel
Slide 10: Cell Therapy has revolutionised blood cancer treatment
Cell Therapy has revolutionised blood cancer treatment CAR-T cells have demonstrated their curative potential in blood cancers For personal use only Product Approval Year 2023 Revenue Cure CAR-T cells have 2017 US$1498m3 demonstrated ability to cure haematological 2017 US$509m4 cancers 2021 US$472
Slide 11: Current CAR-T technology challenges and ALA's solution
Current CAR-T technology challenges ALA’s solution: One CAR-T product only treats the patient who supplied the T cells One CAR-iNKT batch from Manufacturing & supply a healthy donor treats For personal use only T cell chain costs are high multiple patients T cell Each T cells can be manufacturing co
Slide 12: Introducing invariant Natural Killer T (iNKT) cells
Introducing invariant Natural Killer T (iNKT) cells Bridging the innate and adaptive immune system For personal use only Innate Immunity Adaptive Immunity ASX:ALA 10
Slide 13: iNKT cells represent a next-generation cell therapy
iNKT cells represent a next-generation cell therapy Properties make them ideal for use in cell therapy Strong safety profile For personal use only Don’t cause graft versus host disease (GvHD) Innate Front line of the human Immunity immune system Bridge innate & adaptive immune responses Contai
Slide 14: CAR-iNKT cells have multiple ways to kill cancer cells
CAR-iNKT cells have multiple ways to kill cancer cells Also recruit ‘good’ immune cells and block ‘bad’ immune cells For personal use only 1. Via the CAR • Specific target depending on tumour type 2. Via the NKG2D pathway • NKG2D ligands are upregulated in cancer cells TAM Tumour Associated Macropha
Slide 15: A differentiated position
A differentiated position T cell and NK cell sectors are competitive For personal use only T cell iNKT cell NK cell Companies with T cell, NK cell, or iNKT cell therapy programs. Source: Company analysis based on public information ASX:ALA 13
Slide 16: ALA-101 (CAR19-iNKT cells)
For personal use only ALA-101 (CAR19-iNKT cells) A next generation off-the-shelf cell therapy for CD19-positive cancers 14
Slide 17: ALA-101: enhanced tumour killing in vivo
ALA-101: enhanced tumour killing in vivo ALA-101 rapidly eradicates tumour cells in mice Tumour cells positive for CD19 and PBS T iNKT CAR19-T ALA-101 For personal use only CD1d were intravenously delivered into mice Ventral Mice were treated with: PBS (saline) Day 0 Unmodified T cells (T) D
Slide 18: ALA-101: next generation cell therapy
ALA-101: next generation cell therapy ALA-101 significantly increased survival in mice versus treatment with CAR19-T cells Tumour cells positive for CD19 and CD1d For personal use only were intravenously delivered into mice Mice were treated with: P <0.01 PBS (saline) Unmodified T cells (T)
Slide 19: ALA-101: spontaneous secondary remission
ALA-101: spontaneous secondary remission ALA-101 activity may persist to eradicate tumour cells following relapse For personal use only Four mice treated with ALA-101 Ventral had the cancer return to the brain In all four mice, the cancer was eliminated a second time with no Dorsal additional do
Slide 20: Clinic-ready manufacturing process developed
Clinic-ready manufacturing process developed Semi-automated process suitable for large-scale and late-phase clinical development TECHNOLOGY PRE-CLINICAL LENTIVIRUS MANUFACTURING FDA (IND) / PHASE 1 CLINICAL PHASE 2 CLINICAL PLATFORM For personal use only ACQUISITION CONFIRMATION MANUFACTURING TGA (C
Slide 21: Successful pre-IND meeting with FDA
Successful pre-IND meeting with FDA ALA is progressing towards its phase 1 study for ALA-101 For personal use only First formal interaction with FDA Positive feedback and clear path forward to submitting an IND for a Included a review of: phase 1 first-in-human clinical trial • Chemistry, Manufactur
Slide 22: Taking ALA-101 into first-in-human trials
Taking ALA-101 into first-in-human trials ALA is progressing towards its ALA-101-001 phase 1 study Ongoing Clinical trial design and For personal use only IND-enabling studies and Regulatory approval and KOL engagement regulatory submission site startup Engagement with key opinion ALA is conducting
Slide 23: Introducing Arovella's Clinical Advisory Board (CAB)
Introducing Arovella’s Clinical Advisory Board (CAB) World class medical oncologists with early phase clinical trial expertise For personal use only Dr Salvatore (Sam) Fiorenza Dr Debora Barton Professor Sattva Neelapu Epworth HealthCare, Melbourne ANIM8 LLC The University of Texas MD Anderson Austr
Slide 24: ALA-101-001: phase 1 first-in-human study
ALA-101-001: phase 1 first-in-human study Dose escalation and dose expansion study in patients with CD19+ blood cancers Patients with relapsed or refractory CD19+ non-Hodgkin’s For personal use only lymphoma (NHL, including DLBCL, FL, MCL, MZL) and Part 1: Dose Escalation CD19+ leukemias (including
Slide 25: ALA-101-001: anticipated study design
ALA-101-001: phase 1 first-in-human study Anticipated study design For personal use only Inclusion of a broad range Refinement of indications of CD19+ lymphomas and for inclusion in Part 2 based leukemias in Part 1 on safety and efficacy data SCREENING ENROLMENT DOSING RESPONSE ASSESSMENT DAY 28 (+
Slide 26: iNKT cells to target solid tumours
iNKT cells to target solid tumours For personal use only Arovella is implementing its strategy to target and kill solid tumours – 90% of newly diagnosed cancer cases1 1. https://www.cancer.gov/types/common-cancers 24
Slide 27: Arovella's strategies to combat solid tumours
Arovella’s strategies to combat solid tumours Arovella is using three approaches to expand the iNKT cell platform into solid tumours For personal use only License novel Armour Create unique cancer targets iNKT cells partnerships Identify and license Enhance the Create partnerships new targets that a
Slide 28: Solid tumours pose challenges to cell therapies
Solid tumours pose challenges to cell therapies For personal use only Solid tumours are more difficult to treat with cell therapies Access to tumour Lack of antigen iNKT cells: specificity and uniformity Home to tissues and infiltrate tumours Tumour microenvironment Modify the TME to block or kill c
Slide 29: New CARs
New CARs Add additional CARs for novel targets Arovella’s manufacturing process can be leveraged for multiple cancer types MANUFACTURING For personal use only Isolate iNKT cells Expand to grow billions of CAR-iNKT cells Collect Healthy Engineer iNKT cells to Vial and freeze Donor Blood produce CARs
Slide 30: Introducing Claudin 18.2 (CLDN18.2)
Introducing Claudin 18.2 (CLDN18.2) A promising solid tumour target For personal use only CLDN18.2 overexpression has been Validated target identified in several with first monoclonal antibody approved in Japan in 2024 types of cancers gastric cancer (GC) gastroesophageal junction cancer (GEJC) Gast
Slide 31: Armouring CAR-iNKT cells
Armouring “Armouring” CAR-iNKT cells IL-12-TM (cytokine technology) enhances CAR-iNKT cell activity in solid tumours For personal use only iNKT cells IL-12-TM IL-12-TM Expand more 10x more Superior and survive circulating anti-tumour for longer CAR-iNKT cells activity IL-12-TM is a modified version
Slide 32: Key benefits of IL-12-TM for CAR-iNKT cells
Key benefits of IL-12-TM for CAR-iNKT cells IL-12-TM enhances antitumor activity of CAR-iNKT cells Tumour cells positive for GD2 and were For personal use only intravenously delivered into mice before treatment with CAR-iNKT cells Mice were treated with: PBS (saline) GD2-CAR PBS (n=4) GD2-
Slide 33: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 31
Slide 34: Upcoming milestones for FY2025
Upcoming milestones for FY2025 July July 2024 2025 For personal use only Complete cGMP manufacture for Phase 1 clinical trials Complete preparatory activities for Phase 1 study, preparation Arovella is funded to dose ALA-101 of regulatory dossier, engagement with clinical sites and KOLs patients
Slide 35: Summary
Summary Novel allogeneic Lead product progressing CAR-iNKT cell platform to clinical trials For personal use only iNKT cells serve as an excellent platform ALA-101, a potential treatment for to develop allogeneic, or “off-the-shelf”, CD19-expressing blood cancers, is cell therapies to treat cancer b
Slide 36: Thank You
ASX:ALA For personal use only Thank You Dr. Michael Baker CEO & Managing Director Email: investor@arovella.com Mobile: +61 403 468 187
Slide 37: Cell therapy deal references
Cell therapy deal references 1. https://www.astellas.com/en/news/28271 2. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and- autoimmune-diseases.html For personal use only 3. https://www.astrazeneca.com/me
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