Slide 1: MabionCD20 large-scale process update
MabionCD20 large-scale process update Educational webinar July 2020
Slide 2: Disclaimer / Zastrzeżenie
Disclaimer / Zastrzeżenie This document ("Document") has been drawn up by Mabion S.A. The information Niniejszy dokument („Dokument”) został opracowany przez Mabion S.A. Informacje contained in the Document has been collected and prepared with due diligence, zawarte w Dokumencie zebrano i przygotowa
Slide 3: Scientific Advice with EMA and the next steps
Scientific Advice with EMA and the next steps
Slide 4: Scope of the Scientific Advice (SA) documentation
scope of the Scientific Advice (SA) documentation April 2020 July 2020 Mabion filed with EMA Mabion received written advice large-scale manufactured from the regulator referring to the MabionCD20 briefing package scope and format of data to be included in the large-scale application for MabionCD20 7
Slide 5: Mabion addressing SA queries to reach strategic goal
Mabion addressing SA queries to reach strategic goal provide convincing data package (totality of evidence) for the large-scale application Mabion’s sustainable risk management to maximize likelihood of approval goals (avoid „minimum-set-of-data” approach) get EMA approval for the commercial scale p
Slide 6: Mabion's consulted scope of data within the taken approach
Mabion’s consulted scope of data within the taken approach set of analytical analytical set of more than 50 state-of-the-art analytical methods data data package optimal data package to provide Phase 1/2 trial to demonstrate the biosimilarity between MabionCD20 and comparators totality of – clin
Slide 7: Why does additional clinical trial data improve the quality of the MAA?
why does additional clinical trial data improve the quality of the MAA? • certain changes in the manufacturing process implicate necessity to reassess comparability of the biological product by the regulator (comparable quality attributes) • assessment of comparability is a standard procedure requir
Slide 8: Development of the large-scale manufacturing process
development of the large-scale manufacturing process – validation, stability and analytical similarity and comparability data 1 validation of manufacturing process validation pursued in line with the initial schedule 3 batches of drug substance manufactured; drug product ready for release (final s
Slide 9: Assumed timeline of large-scale application processing in EMA
assumed timeline of large-scale application processing in EMA process validation stability testing - continuous analytical similarity and comparability assessment clinical trial preparation clinical trial EMA’s marketing authorization procedure closing of dossier, filing of large-scale application 2
Slide 10: Development of the large-scale dossier and near-term activities
development of the large-scale dossier and near-term activities accomplished near-term activities scientific advice document received and analyzed opening tenders for CROs 3 batches of product manufactured advancing stability study tender documentation for CROs in final preparation comme
Slide 11: Financing of the large-scale development and regulatory process until EMA approval
financing of the large-scale development and regulatory process until approval from EMA main areas of spending* sources of financing * does not include running costs and CAPEX for increasing capacity loans new public equity raise (including loans stability tests from founders) grants R&D analytical
Slide 12: MabionCD20 operational and regulatory pathway in the US
MabionCD20 operational and regulatory pathway in the US • continuation of the initiated regulatory process in the US - ongoing consultation with US FDA regarding clarification of the scope of the bridging study (following Type 3 BPD meeting protocol) - next expected regulatory step will comprise Typ
Slide 13: Withdrawal assessment report contents
Withdrawal assessment report contents
Slide 14: WAR redaction – Recommendations section
WAR redaction – „Recommendations” section „Based on the review of the data on quality, safety and efficacy, on 12th of December 2019 the CHMP considers that the application for Rituximab Mabion (also referred MabionCD20), in the treatment of Non-Hodgkin’s lymphoma (NHL), Chronic lymphocytic leukaemi
Slide 15: Consistent and methodical work on resolving the Regulator's questions
consistent and methodical work on resolving the Regulator’s questions quantity of EMA questions at each stage assessment report for MabionCD20 was drafted for the „Day 195”, i.e. status in Nov/Dec2019, when a number of unresolved issues remained. They were further addressed and largely solved by the
Slide 16: Mabion S.A. kontakt IR - cc group
Mabion S.A. Kompleks Naukowo-Przemysłowy Biotechnologii Medycznej ul. Langiewicza 60 95-050 Konstantynów Łódzki tel +48 42 207 78 90 kontakt IR - cc group Piotr Owdziej tel +48 22 440 1 440 mail piotr.owdziej@ccgroup.pl Katarzyna Mucha tel +48 22 440 1 440 mail katarzyna.mucha@ccgroup.pl