CTM CRC The CRC for Cell Therapy Manufacturing

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CTM CRC The CRC for Cell Therapy Manufacturing (CTM CRC) is a $60 M

CTM CRC The CRC for Cell Therapy Manufacturing (CTM CRC) is a $60 M collaboration between industry, academia and health providers Vision: To increase the accessibility, affordability and efficacy of cell therapies Mission: CTM CRC’s mission is to ensure more efficient and cost-effective cell isolation, expansion and delivery by: § Developing novel technologies that integrate smart materials and interfaces for improved cell processes § Facilitating the pilot scale-up and translation of technologies

CTM CRC Capabilities • Manipulate cellular behaviour through interaction with functionalised surfaces • Development

CTM CRC Capabilities • Manipulate cellular behaviour through interaction with functionalised surfaces • Development and optimisation of advanced surfaces and analysis • Biomaterials design • Bioanalytical expertise • Regulatory expertise • Preclinical experience • Pilot-scale expansion and manufacturing Technology Applications Adult progenitor cell expansion – Functionalised surfaces for more efficient large-scale expansion of cells, such as MSCs Controlled delivery of ancillary reagents – Specialised surfaces for more efficient supply of critical and expensive reagents for cell growth Topical delivery of adult progenitor cells – Surfaces that allow targeted delivery of cell therapies to specific sites of action for improved efficacy Antifouling surfaces – Reducing incidence of thrombosis and restenosis of vascular/coronary stents Pluripotent stem cells – Surfaces to promote expansion and targeted differentiation of cells, such as i. PS cells T cells – Activation, expansion and delivery

Development Themes Cellular Immunotherapies Materials & Interfaces • Cheaper and more practical cell isolation,

Development Themes Cellular Immunotherapies Materials & Interfaces • Cheaper and more practical cell isolation, expansion and delivery technologies, through the use of smart materials and functionalised surfaces • Addresses the efficacy, manufacturing and delivery challenges facing the T cell therapy industry Pilot Manufacturing CTM CRC • Scale-up of surfacefunctionalisation and cell expansion capabilities for proof-of-concept studies and rapid translation of technologies

Biomaterials Plasma treatment (chemical coating) Electrospun scaffolds Materials capabilities can be tailored to suit

Biomaterials Plasma treatment (chemical coating) Electrospun scaffolds Materials capabilities can be tailored to suit a range of expansion technologies and cell types: • Adult progenitor cells • T cells • i. PS cells Hydrophobic scaffolds Hydrogel scaffolds 3 D Lattices

#2 Topical Delivery of Progenitor Cells Product concept: Delivering cells from a dressing adult

#2 Topical Delivery of Progenitor Cells Product concept: Delivering cells from a dressing adult progenitor cells medical grade backing PP treated surface frozen and stored wound treatment PATENT PENDING

#3 Antifouling & Cell-attracting Surfaces Functionalised surfaces for improved vascular repair § Improvement in

#3 Antifouling & Cell-attracting Surfaces Functionalised surfaces for improved vascular repair § Improvement in performance of vascular stents by § Reducing incidence of thrombosis/re-stenosis § Increasing re-endothelialisation of vessel walls § Patented process for coating bare metal stents § Reduces fouling of stent struts § Allows for functionalisation of stent with biomolecules to promote re-endothelialisation

Cellular Immunotherapies T cell expansion- Novel material for the ex vivo expansion of T

Cellular Immunotherapies T cell expansion- Novel material for the ex vivo expansion of T cells, designed to integrate into existing T cell expansion platforms Cancer target for CAR-T therapy –Specific cancer antigen as a potential CAR-T cell target for the treatment of solid tumours Tregs for immunomodulation – Expansion protocols for a more stable Treg phenotype Targeted delivery – Surfaces and gels to allow targeted delivery of cells to sites of action for improved efficacy and reduced dose Gene delivery – Devices and technologies to improve delivery of DNA/RNA into cells, for cell and gene therapies

Cellular Immunotherapies #4 CTM CRC capabilities utilised across immunotherapy manufacturing PATENT PENDING Novel CAR-T

Cellular Immunotherapies #4 CTM CRC capabilities utilised across immunotherapy manufacturing PATENT PENDING Novel CAR-T cell target 1 Leukapheresis 2 Selection & Activation 3 D lattice for T-cell activation PATENT PENDING 3 Gene Transfer High efficiency (>90%) Tcell transformation methods which can be automated 4 Cell Expansion 3 D lattice for T-cell expansion which matches or exceeds magnetic bead performance & suitable for automation 5 Delivery Phase-shifting gel for delivery of CAR-T to tumour resection sites

Pilot Manufacturing Tek. Cyte. TM is a CTM CRC translational and pilotscale manufacturing facility

Pilot Manufacturing Tek. Cyte. TM is a CTM CRC translational and pilotscale manufacturing facility to facilitate new technology development and translation into the clinic § § § Validation of lab-based technologies at a larger scale, prior to more expensive product development and commercial scale-up More accurate modelling and comparison of impact on manufacturing costs Critical infrastructure to deliver specialist training in c. GMP manufacturing of advanced therapies to private- and publicsector organisations 71% 79% 86% 97%

Pilot Manufacturing Tek. Cyte. TM Systems to test CTM CRC technologies Dedicated cleanroom suite

Pilot Manufacturing Tek. Cyte. TM Systems to test CTM CRC technologies Dedicated cleanroom suite including two Grade B c. GMP-standard manufacturing suites § Designed to meet international standard ISO 14644 and follow the PIC/S guide to GMP of medicinal products, Annex 1 § Separate AHU supply allowing for two simultaneous manufacturing activities § Transparent glass wall and AV facilities provide view into clean room for training purposes 71% 79% 86% 97%

Contact CTM CRC for Cell Therapy Manufacturing Level 5 Catherine Helen Spence Building Uni.

Contact CTM CRC for Cell Therapy Manufacturing Level 5 Catherine Helen Spence Building Uni. SA City West Campus Adelaide SA 5000 T +61 8 8302 3503 E info@ctmcrc. com