From Concept to Capacity: Navigating the Intersection of Innovation, Investment, and Sustainable Growth — The GPN Story

• Targeted innovation for unmet needs: How GPN uses innovation to address market gaps beyond existing vaccine platforms
• Strategic capital & partnerships: Using focused investments and partnerships to drive an agile development pipeline
• Early quality integration: Embedding quality, regulatory, and project management early to support scale and long-term growth

Arg-Glu, An Ideal Excipient for High Concentration Monoclonal Antibody Formulations

• Understanding high concentration mAb formulations and its challenges
• Introduction of A-172 Arg-Glu, a desirable excipient for high concentration mAb formulations
• Case study: evaluation of Arg-Glu as an anti-aggregation agent
• Conclusion of Arg-Glu for high concentration mAb formulation

Leadership Panel: Advancing Biologics & CGT in ANZ - Innovation, Investment & Market Readiness

• Strengthening CMC, manufacturing, regulatory, and market access capabilities to compete globally
• Attracting long-term investment and accelerating commercialization of biologics and CGT pipelines
• Leveraging clinical trial infrastructure, real-world evidence, and data insights to support approvals and adoption

iPSC-Derived MSCs in Clinical Practice: Phase 3 Data with Guideline-Changing Potential

• iPSC-derived MSCs deliver consistent quality, scalability, and eliminate donor variability vs tissue-derived MSCs
• Overview of Cynata’s two clinical programs with results expected in Q2 2026
• Phase 3 CYP-004 in knee osteoarthritis has potential to change clinical guidelines

Next-Generation CAR-T Therapies Targeting Kappa & Lambda Myeloma Antigens

• KMA- and LMA-targeted CAR-T cells selectively attack malignant plasma cells while sparing normal cells
• Novel antibodies recognize unique conformational epitopes specific to myeloma antigens
• Strong preclinical data supports precision targeting of kappa- and lambda-expressing myeloma cells

Beyond CAR-Cell Therapy: Off-the-Shelf Exosome Immunotherapy for Solid Tumours

• Deep tumour penetration: CAR-EVs (50–150 nm) can effectively infiltrate solid tumour microenvironments
• Strong efficacy, lower risk: Delivers CAR-T-like immune effectors with minimal CRS or GvHD risk
• Cost-effective therapy: Off-the-shelf approach at ~10× lower cost than CAR-T

Increasing Patient Access to CAR-T Therapy in ANZ & Southeast Asia

• Limited access in smaller markets across the region
• Barriers: reimbursement, supply chain complexity, and high costs
• Solutions and models to improve access and affordability

Development Of CAR-iNKT Cells for the Treatment of Haematological Malignancies and Solid Tumours

• iNKT cells are unique immune cells well-suited for developing therapies against blood cancers and solid tumours
• Arovella’s lead product ALA-101 (CAR-CD19 iNKT cells) is in development for CD19-positive lymphoma and leukaemia
• Pipeline expansion includes ALA-105, a CAR-iNKT cells targeting CLDN18.2, expressed in gastric and pancreatic cancers

CNA3103, The First Australian-discovered CAR-T Cell Therapy to Enter Clinical Trials: The Journey So Far

• CNA3103 is a first-in-class, third-generation CAR-T targeting the cancer stem cell marker LGR5
• LGR5 drives cancer initiation, progression, and metastasis in certain solid tumours, including colorectal, ovarian, and gastric cancers
• Early Phase 1 clinical data in patients with colorectal cancer will be presented

Powering the Future of Cell Therapy: Capability Building, Challenges, and What’s Next at Cartherics

• How Cartherics has built a strong discovery-to-clinic engine
• Why cell therapies have transformed blood cancers but still face major challenges in solid tumours
• How Cartherics is addressing and overcoming these key challenges

End of Conference Day 1