Corporate Update - MDG1021 discontinuation
28 January 2021
Forward looking statements disclaimer
All of the information herein has been prepared by the Company solely for use in this presentation. The information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The information contained in this presentation should be considered in the context of the circumstances prevailing at that time and has not been, and will not be, updated to reflect material developments which may occur after the date of the presentation. The Company may alter, modify or otherwise change in any manner the content of this presentation, without obligation to notify any person of such revision or changes.
This presentation may contain certain forward-looking statements and forecasts which relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on the Company's business, financial condition and results of operations. The terms
"anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "will",
"would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of the Company's strategy and its ability to further grow, risks associated with the development and/or approval of the Company's products candidates, ongoing clinical trials and expected trial results, technology changes and new products in the Company's potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. While we always intend to express our best judgment when we make statements about what we believe will occur in the future, and although we base these statements on assumptions that we believe to be reasonable when made, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of our control and could cause our actual results to differ materially from those we thought would occur. The forward-looking statements included in this presentation are made only as of the date hereof. We do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.
2
Medigene - Innovative T cell therapies for solid tumors
Focus on innovative T cell-based immunotherapies
Excellence in TCR discovery
Healthy TCR repertoires screened: Scale & speed
Optimal TCR properties: Avidity & specificity
Antigen targets of choice
Excellence in functional enhancements of therapeutic T cells
Resistance to inhibitory tumor microenvironment
Augmented metabolic fitness
Advancing clinical development from liquid to solid cancers
Prof. Dolores J. Schendel
CEO & CSO
3
Key information
Company
Martinsried, near Munich, Germany
~100 employees at end 2020
~€35.8 m cash*
COVID-19 Situation Update
Personnel
Work from home and on-site
Partner Programs
Continued R&D activities at Medigene support partners
Clinical Trials
No COVID-19 related delays in Germany
*As of 30 Sep 2020; **At close 27 January 2021
Listing
Frankfurt Stock Exchange (MDG1)
~24.6 m shares outstanding ~€110 m market cap**
Outlook
MDG1011 Phase I/II trial anticipating 3rd dose cohort to be dosed in Q1 2021
Publication of clinical and preclinical data at conferences
bluebird bio: MAGE-A4TCR-T + enhancer in preclinical development
Roivant/Cytovant: DC vaccine progressing towards clinic
4
Growing immunotherapy pipeline
TCR-T
Project | Target | Preclinical | Phase I | Phase II | Partner | ||||
MDG1011 | AML, MDS | ||||||||
(PRAME) | |||||||||
MDG10XX | Solid tumors | |||||||
(undisclosed) | ||||||||
bluebird bio | Undisclosed | |||||||
(MAGE-A4) | ||||||||
Cytovant | Synovial sarcoma, | |||||||
MM, solid tumors | ||||||||
(CVT-TCR-01) | ||||||||
(NY-ESO-1) | ||||||||
DC
DC vaccine | AML | |||||||
(WT-1 / PRAME) | ||||||||
Cytovant | AML | |||||||
(CVT-DC-01) | (WT-1 / PRAME) | |||||||
PRAME, MAGE-A4,NY-ESO-1, WT1: Tumor antigens; | Completed; | Ongoing; | In preparation | 5 | |||
MDG1021 - Program discontinuation
HA-1-specificTCR in-licensed from Leiden University Medical Center (LUMC)
Safety and feasibility had previously been tested in a Phase I clinical trial in 5 patients
Medigene Phase I clinical trial initiated at the LUMC in mid-2020
Trial was to assess the treatment of relapse after hematopoietic stem cell transplantation
Decision to discontinue
Trial enrollment challenges - no patients treated in first 7 months
Recent recruitment experience of other groups with similar HA-1 targeted therapy highlights hurdles Timeline for trial likely to be protracted with additional pressure around ongoing pandemic
Focus of company now on solid tumor indications using functionally enhanced TCR-Ts
6
Focus: Enhanced TCR-Ts for solid tumors
Excellence in TCR selection
TCR repertoires from healthy donors as source of TCRs
Assay tree to select optimal target-specific TCRs
Potency - high avidity - low density peptide-HLA per target cell
Safety/specificity - exhaustive assessment to minimize potential cross-reactivity
Functional enhancement of TCR-Ts through PD1-41BB
Checkpoint pathway - inhibition turned into activation
Antigen specific activity
Metabolic fitness
TCR-Ts able to function in hostile tumor microenvironment
Duration of activity
TCR-Ts able to kill repeatedly over many cycles
Longevity of TCR-Ts to favor sustained clinical responses
7
Key messages
Medigene direction to build value through tightly focused operations
Pre-clinical development targeting solid tumors
Focused on next-generationTCR-T therapies with T cell enhancement bluebird bio - MAGE-A4TCR-T + enhancer in preclinical development
Clinical programs
Complete MDG1011 Phase I dose escalation trial
Roivant/Cytovant progress DC vaccine into clinical trial in AML in 2021
Business development
Continue to support collaborations with bluebird bio and Roivant/Cytovant
Progress DC vaccine out-licensing
Global outreach for additional partnerships
Financials
Cash runway into Q3 2022
8
Contact
Medigene AG | T +49 | 89 2000 33 0 |
Lochhamer Str. 11 | F +49 | 89 2000 33 2920 |
82152 Planegg / Martinsried | investor@medigene.com | |
Germany | www.medigene.com |
© Medigene AG
Attachments
- Original document
- Permalink
Disclaimer
MediGene AG published this content on 28 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 January 2021 15:15:00 UTC.