Latest News by Industry
MARTINSRIED, Germany and MUNICH, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focused on the development of differentiated, best-in-class T Cell Receptor engineered T cell (TCR-T) therapies, today announces an updated corporate strategy to drive and expedite the development of novel therapies for the treatment of multiple solid tumor indications with high unmet need.
“We are excited to announce this strategy and corporate update for Medigene,” said Dr. Selwyn Ho, MB BS, Chief Executive Officer at Medigene. “At the heart of our work is our extensive expertise on T cell immunology and many years of development of a proprietary, innovative “end-to-end” platform under the leadership of our Chief Scientific Officer, Prof. Dolores Schendel.
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 Medigene, as well as through the success of our MDG1011 phase 1 trial.
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. James Cornicelli as Head of Corporate Development and Strategy. As a highly seasoned executive with over 20 years in senior business development and strategic advisory roles, Mr. Cornicelli brings multiple areas of expertise that will help guide our company on critical decisions about partnering and accelerate our growth strategy.”
Strategic Actions Summary:
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.
MDG1015, the company’s lead program, consists of a novel TCR against NY-ESO-1 (New York esophageal squamous cell carcinoma 1), a well-characterized cancer testis antigen (CTA) expressed in multiple tumor types combined with our PD1-41BB Switch Receptor technology, which blocks the PD1/PD-L1 inhibitory axis between T cells and tumors and activates the 41BB co-stimulatory pathway in TCR-T cells. This co-stimulation and reduced inhibition, help mitigating the negative effects of the solid tumor microenvironment, leading to multiple improvements in the activity of MDG1015, including improved tumor cell killing, greater effector T cell function, and enhanced T cell proliferation. For MDG1015 we expect a CTA / IND filing in 2H 2024.
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.
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:
Medigene is also currently developing additional novel and complementary technologies to add to our platform that will further optimize the development of and continue to enhance our TCR-T therapies.
To date, multiple partnerships have been established that validate our “end-to-end” platform assets and technologies, including with BioNTech, 2SeventyBio, and Hongsheng Sciences. Medigene will continue to work closely with our existing partners and explore new partnership opportunities to maximize the value of our current and future assets and technologies and ultimately deliver novel and differentiated TCR-T therapies to patients.
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 UK meeting in London, in November 2022 with the presentation available on Medigene’s website. The expanded clinical dataset from the trial will be available in due course.
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 Wednesday, November 16, 2022, at 3 pm CET. A Q&A session will follow management’s formal presentation. A new corporate deck providing an overview of Medigene’s technologies, pipeline, and strategic vision can now be found here: https://www.medigene.com/investors-media/reports-presentations
Full details for the webcast are as follows:
| Date: | November 16, 2022 | |
| Time: | 3:00 pm Central European Time | |
| U.S. Dial-in Number | 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 Medigene
Medigene AG (FSE: MDG1) is a late pre-clinical stage immuno-oncology company, focusing on discovering and developing differentiated, breakthrough cellular therapies to improve the lives of cancer patients. With an end-to-end technology platform built on multiple proprietary and exclusive product enhancement and product development technologies, Medigene aims to create best-in-class TCR-modified T cell (TCR-T) therapies that are optimized for both safety and efficacy. Our strategy is to develop product candidates both for our in-house therapeutics pipeline and for partnering. For more information, please visit www.medigene.com.
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 Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene®is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.
Medigene
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com
LifeSci Advisors
Sandya von der Weid
Phone: +41 78 680 05 38
E-mail: svonderweid@lifesciadvisors.com
In case you no longer wish to receive any information about Medigene, please inform us by e-mail ( investor@medigene.com ). We will then delete your address from our distribution list.