- Company strategy focused on developing differentiated TCR-T therapies from its proprietary “end-to-end” platform to target solid tumors with high unmet need
- Pipeline expansion and acceleration of lead candidates with aim of advancing them into clinical development
- Lead program, MDG1015, a TCR-T therapy for NY-ESO-1 combined with PD1-41BB Switch Receptor technology; at CTA /IND enabling phase, with submission planned for 2H 2024
- Second program, MDG10xx, TCR-T therapies for yet undisclosed targets combined with PD1-41BB Switch Receptor technology; candidate selection to be announced 2H 2023
- Additional technologies in development to enhance the “end-to-end” platform
- Current cash runway maintained into Q4 2024
- Management to host a conference call and webcast to discuss details of strategic update on
Wednesday, November 16, 2022 , at3 pm CET
MARTINSRIED,
“We are excited to announce this strategy and corporate update for Medigene,” said Dr. Selwyn Ho, MB BS, Chief Executive Officer at
With the platform containing multiple combinable technologies that optimize the development of, as well as enhance the TCR-T products from both an activity and potential safety perspective, we believe that our emerging TCR-T therapies have the potential to address the significant challenges that solid tumors create for immunotherapies, and improve clinical outcomes. The robustness of our work has been well validated through multiple partnerships where potentially highly differentiated TCRs and novel individual technologies have been licensed from
We are focused on delivering best-in-class TCR-T therapies to patients suffering from difficult to treat tumors and have accelerated and prioritized our research activities. Our lead program, MDG1015, is a 3rd generation TCR-T therapy that combines a novel TCR against NY-ESO-1, a well-characterized and validated cancer antigen expressed in multiple tumor types, with the PD1-41BB Switch Receptor that significantly improves the ability of our TCR-T cells to kill cancer cells. This program has the potential for a more targeted, safer, and potent immune response while overcoming highly immunosuppressive tumor microenvironment.
To support our efforts, we continue to strengthen our leadership team and have appointed Mr.
Strategic Actions Summary:
- TCR-T Therapies Central to Medigene’s Approach
Medigene’s strategy will focus on developing best-in-class T Cell Receptor engineered T cell (TCR-T) therapies. TCR-T therapies are a novel class of cellular immunotherapy with the ability to engage both surface and intracellular antigens on target cells, unlike CAR-T cell-based therapies, allowing for solid tumor targeting in a highly specific manner. The first generation of TCR-T therapies have shown improvements in outcomes in solid tumor clinical trials; however, unmet needs remain for further improvements in efficacy, that are sustained and with a lower risk of adverse effects.
- Pipeline Expansion and Acceleration of Discovery Programs MDG1015 and MDG10xx
MDG1015, the company’s lead program, consists of a novel TCR against NY-ESO-1 (
MDG10xx is our second newly announced TCR-T therapy program against several undisclosed targets, in combination with the PD1-41BB Switch Receptor technology. The selection of a lead candidate for MDG10xx is planned for the second half of 2023.
- Advancing Broad, Proprietary “End-to-End” Platform
Medigene’s “end-to-end” platform provides multiple combinable, exclusive, and proprietary technologies to create potential best-in-class TCR-T therapies to address the unmet needs in the treatment of solid tumors. The platform includes technologies that both help optimize our development activities as well as to enhance our TCR-T therapy products, during the stages of target screening, TCR generation, TCR-Therapy optimization, manufacturing, and clinical development. These include:
- EXPItope-M: Proprietary in silico tool to identify immunogenic epitopes as potential TCR target specificities.
- Allo-HLA TCR priming technology: Generation of high-affinity natural TCRs, for improved sensitivity and safety, by bypassing the thymic selection
- CrossTAg vector system: Technology loads antigen on both HLA Class I and Class II complexes in antigen-presenting cells (APCs), creating stronger and more sustained immune responses
- JOVI-Tag: Tool allowing standardized enrichment and tracking of recombinant TCR (rTCR) -expressing T cells to enable selection of safer TCRs when using HTS
- PD1-41BB Co-Stimulatory Switch Receptor: A novel, highly innovative receptor that enhances TCR-T cell functionality, enabling it to mitigate against immunosuppressive tumor microenvironment (TME) and improves efficacy and sustained immune responses
- Precision Pairing: Enables the modification and tailoring of TCR constant regions to improve pre-clinical efficacy through the enhanced anti-tumor functional activity of TCR-T cells and potential for improved safety by reducing the potential for off-target effects
- Inducible iM-TCR: Control mechanism to regulate TCR-T therapy efficacy & safety, to avoid T cell exhaustion, cell death, and a loss of efficacy as well as to prevent over-activation of TCR-T which can mediate inflammatory responses in off-target tissues
- Strengthening & Expanding our Partnership Approach By Leveraging our Innovative Assets & Technologies
To date, multiple partnerships have been established that validate our “end-to-end” platform assets and technologies, including with BioNTech, 2SeventyBio, and Hongsheng Sciences.
- Focus on Solid Tumors
As previously announced, we have successfully completed our phase 1 MDG1011 program in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and multiple myeloma (MM). The MDG1011 trial provides clear clinical validation of our ability to generate and manufacture TCR-T therapies and details of our manufacturing process have been shared at the Cell
Despite this positive trial for MDG1011, as previously disclosed, we have focused any further research and development efforts towards solid tumors. The company is accelerating our plans to identify a suitable strategic partner and will provide an update in due course.
Webcast on Updated Corporate Strategy
The company will host a live conference call and webcast on its updated strategy on
Full details for the webcast are as follows:
Date: | ||
Time: | ||
1-877-451-6152 | ||
Int'l Dial-in Number: | 1-201-389-0879 | |
Conference ID: | 13734186 | |
Webcast: | Click Here | |
Following the call, an archived webcast will also be accessible on the Investor & Media section of the Medigene Web site https://www.medigene.com/investors-media/reports-presentations
About
About Medigene’s TCR-T cells
T cells are at the center of Medigene’s therapeutic approaches. Medigene’s immunotherapies help activate the patient’s own defense mechanisms, and harness T cells in the battle against cancer. Medigene’s therapies arm the patient’s own T cells with tumor-specific T cell receptors (TCRs) creating TCR-modified T cells with enhanced potential to detect and efficiently kill cancer cells.
Medigene’s approach to immunotherapy is designed to overcome the patient’s tolerance of cancer cells and tumor-induced immunosuppression. By activating the patient’s T cells outside the body, genetically modifying them with tumor-specific TCRs and expanding the resultant activated TCR-T cells, patients can rapidly be given large numbers of tumor-specific T cells to fight their cancer.
This press release contains forward-looking statements representing the opinion of
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E-mail: investor@medigene.com
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