Medigene Announces Strategy and Corporate Update

• 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, at 3 pm CET

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 3^rd 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:

• 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 (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.

• 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

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.

• 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. 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.

• 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 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:

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.

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E-mail: investor@medigene.com

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