Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — Corporate Update (October 2017)
24 slides from Iovance Biotherapeutics's corporate update, Oct 26, 2017
Slide 1: Manufacturing Tour at WuXi AppTec
Manufacturing Tour at Wuxi AppTec October 26, 2017 © 2017, Iovance Biotherapeutics
Slide 2: Forward-looking statements
This presentation contains forward - looking statements reflecting management’s current beliefs and expectations . These forward looking statements can be identified with words such as “expects”, “plans”, “projects”, “potential”, “suggests”, “may”, or similar expressions . Such forward - looking sta
Slide 3: Manufacturing Capacity in US and EU
© 2017, Iovance Biotherapeutics Manufacturing Capacity in US and EU • Clinical and commercial manufacturing capabilities are in place in the US and EU ̶ WuXi established at multiple suites in US ̶ LonzaNL (formerly PharmaCell ) tech transfer in process in EU • All currently planned clinical studies
Slide 4: Adequate Manufacturing Capacity and IP Rights
• Iovance’s manufacturing process is centralized at the following CMO sites: ̶ Lonza, Walkersville ̶ Wuxi AppTec ̶ Moffitt as CMO ̶ LonzaNL (EU) • Iovance developed the Gen 1 process through modification of the NCI’s TIL manufacturing method. Gen 2 and all manufacturing SOPs were developed by Iovanc
Slide 5: Accomplishments and Upcoming Objectives
x Development of a new manufacturing cycle from 5 - 6 weeks to under 3.5 weeks x Complete tech transfer and ramp volumes at WuXi AppTec and H. Lee Moffitt Cancer Center and Research Institute x Continue working with Lonza x Expand capacity into additional CMOs x LonzaNL (EU) x Continue efforts to re
Slide 6: Iovance Manufacturing Process & Logistics
Iovance Manufacturing Process & Logistics © 2017, Iovance Biotherapeutics Gen 1 Duration: ~5 - 6 Weeks Gen 2 Duration: ~3.5 Weeks Cryopreserved Product Excise tumor Shipment IV infusion Post - Lymphodepletion + IL - 2 Dissect tumor into fragments Expansion with IL - 2 Co - culture TIL with feeder ce
Slide 7: WuXi US Clinical & Commercial Manufacturing Facility
© 2017, Iovance Biotherapeutics WuXi US Clinical & Commercial Manufacturing Facility 7 Commercial Cell Therapy Center of Excellence Commerce Center 3 • 55,000ft 2 manufacturing site • Warehouse space • In - process QC testing • Compliant with US & EU regulations • Up to 8 - 10 large GMP manufacturin
Slide 8: WuXi US Clinical & Commercial Manufacturing Facility
© 2017, Iovance Biotherapeutics WuXi US Clinical & Commercial Manufacturing Facility 8 LI1 Production Facility • Satellite Warehouse • Central QC Lab CC3 Production Facility • Central Warehouse Manufacturing Facilities Inbound Supplies Tumor Receipt Samples to QC Lab (CC3 to LI 1) Final TIL Product
Slide 9: Tumor Harvest & Shipment to Manufacturing
© 2017, Iovance Biotherapeutics Tumor Harvest & Shipment to Manufacturing • Once resected tumor is placed in a bottle with media and packaged in accordance with validated shipping procedures • Courier is notified days before scheduled pickup and arrives at site to receive package • In conjunction wi
Slide 10: CC3: Inbound Tumor Receipt and Gowning
CC3: Inbound Tumor Receipt and Gowning © 2017, Iovance Biotherapeutics 10 • In - bound: • In - bound receipt area where tumor is received • Delivered by courier and verified by a unique site and patient number • Product is matched with WuXi lot number • Temperature data downloaded and product is del
Slide 11: CC3: Manufacturing and Final Packaging/Cryopreservation (Gen 2)
CC3: Manufacturing and Final Packaging/Cryopreservation (Gen 2) © 2017, Iovance Biotherapeutics 11 • Controlled rate freezing and LN2 storage area • Courier notified to provide Cryoshipper in conjunction with manufacturing completion • Prepare shipment utilizing validated procedures for cryofreezing
Slide 12: Gen 2 Manufacturing Process
© 2017, Iovance Biotherapeutics Gen 2 Manufacturing Process • 3.5 week cell expansion process with a cryopreserved product delivered to clinical sites for patient infusion • Robust, efficient and scalable process • Provides flexibility to manufacturing and clinical sites • Provides flexibility to si
Slide 13: TrakCel: Integrated Scheduling Solution
© 2017, Iovance Biotherapeutics TrakCel : Integrated Scheduling Solution • In September 2017, announced new partnership with TrakCel ̶ An automated process integrating scheduling, capacity and logistics throughout the supply chain ̶ Compliance – 21 CFR Chapter 21 compliant with electronic audit reco
Slide 14: Cell & Gene Therapy Manufacturing
Cell & Gene Therapy Manufacturing
Slide 15: Our Journey
Our Journey 2017 Global Platform 2017 16,000+ employees worldwide >5 million ft 2 existing & upcoming R&D space leading capability and technology platfor m 15
Slide 16: Our Platform
Our Platform Comprehensive R&D Enabling Capabilities Small Molecules Biologics Cell & Gene Therapies Medical Devices Molecular Testing and Genomics 16
Slide 17: Manufacturing Experience / Capabilities
Manufacturing Experience / Capabilities
Slide 18: Philadelphia Facilities
Philadelphia Facilities Cell & Gene Therapy Manufacturing and Testing 2004 2015 55,000 SF - Manufacturing for Autologous / Allogeneic Cell Therapies 75,000 SF - QC Testing, PD, Cell Therapy Manufacturing 150,000 SF - CAR - T Cell Therapies and Gene Therapy Manufacturing 2004 2015 18
Slide 19: Manufacturing Team
Manufacturing Team Cell Culture, PD and Tech Transfer Teams (~200 staff Q1 2017) ▪ Cross trained for Cell Banking and Cellular Therapeutics processing ▪ 7 days a week coverage ▪ Currently 2 shifts - Sun - Wed and Wed - Sat; with Manufacturing Supervisors Quality Assurance Team ▪ QA Raw Materials ▪ Q
Slide 20: Chain of Identity (COI) Meeting FDA Expectations
Chain of Identity (COI) Meeting FDA Expectations ▪ Tracking of all products from the donor to the consignee or final disposition, and from consignee or final disposition to donor (21 CFR 1271.290(b)) ▪ Appropriate patient identifiers and procedures to prevent product mix - ups ▪ Procedures in place
Slide 21: Facilities for CT Manufacturing FDA and EMA Expectations
Facilities for CT Manufacturing FDA and EMA Expectations ▪ Establish adequate facility and equipment performance standards and monitoring plans ▪ Ensure aseptic environment for cell processing through design and monitoring* ▪ Use closed systems where possible ▪ Use disposable equipment and process a
Slide 22: Process Development for Commercialization
Process Development for Commercialization Early and Late Phase Development Program Pre - clinical PhI PhII PhIII Commercial Late Development Process Final Manufacturing Process Early Development Process Continuous Process Verification Process Improvement Process Validation Research Process • The dev
Slide 23: Capabilities – Cell Therapies
Capabilities – Cell Therapies Established QC & Analytical Testing ▪ GMP Cell Banking & Characterization ▪ Viral Bank Safety & Characterization ▪ Raw Material Testing ▪ Extractables / Leachables Testing ▪ Lot Release / Stability Testing • Mycoplasma( PCR, Points To Consider, EP) • Sterility(USP, BacT
Slide 24: Manufacturing Tour at WuXi AppTec
Manufacturing Tour at WuXi AppTec October 26, 2017 © 2017, Iovance Biotherapeutics
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