Medigene Announces Pipeline Expansion into Neoantigens with Programs Targeting Multiple KRAS Mutations and HLAs

Medigene AG

• Medigene is building a broad KRAS library consisting of multiple T cell receptors (TCRs) targeting multiple KRAS mutations and multiple HLAs, covering large patient populations suffering from solid tumors with high unmet need

• KRAS TCR-T programs to benefit from combination with Medigene’s expanded library of proprietary product enhancement technologies including its PD1-41BB and potentially CD40L-CD28 costimulatory switch receptors

• Management to host an R&D Event to discuss pipeline expansion and evolution of the end-to-end platform on Tuesday, June 20, 2023, at 10:00 am ET

Planegg/Martinsried, June 1, 2023. Medigene AG (Medigene, FSE: MDG1, Prime Standard),  an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today announces its pipeline expansion into neoantigens (also known as oncogenic driver mutations) with KRAS (Kirsten rat sarcoma viral oncogene homologue) as the first target in its MDG10xx program, a T cell receptor engineered T cell (TCR-T) therapy being developed in combination with the company’s PD1-41BB switch receptor technology. The first KRAS antigens and HLAs (human leukocyte antigens) of the library announced today are targeting:

• KRAS G12V-A11 (MDG2011)

• KRAS G12V-A03 (MDG2012)

• KRAS G12D-A11 (MDG2021)

Neoantigens are tumor-specific antigens (TSA) and play a critical role in the growth of tumors. These mutations are found in many solid tumors and their prevalence varies depending on the cancer type. KRAS mutations are widely recognized as the most common oncogene mutations in difficult-to-treat solid tumors existing in ~30% of solid tumors, such as pancreatic, colorectal, endometrial and non-small-cell lung cancer. Global incidence of solid tumors expressing KRAS mutations is estimated to be in excess of 300,000 patients.

“Our pipeline expansion into neoantigens with multiple KRAS targets represents a major advance in our pursuit to develop best-in-class TCR-T therapies for patients suffering from difficult-to-treat solid tumors,” said Dr. Selwyn Ho, Chief Executive Officer at Medigene. “We are delighted that this latest milestone continues to validate Medigene’s proprietary end-to-end platform as the basis for our highly specific, sensitive and potentially safer TCRs with optimal affinity. These TCRs will be combined with the PD1-41BB and/or the CD40L-CD28 costimulatory switch receptors to enhance the proliferation and persistence of the TCR-T cells and to help mitigate the immunosuppressive effects of the tumor microenvironment.”

Dr. Ho continued, “We confirm our guidance to announce the first lead candidate for MDG10XX, which has been renamed as MDG2011, in Q3 this year and expect to announce new TCRs in the near future as we build the broadest KRAS library possible.”

R&D Event

The Company will host an R&D Event to discuss the pipeline expansion and the evolution of its end-to-end platform on Tuesday, June 20, 2023, at 10:00 am ET. A Q&A session will follow the formal presentations and discussions.

Full details for the webcast and registration are as follows:

Date:	June 20, 2023
Time:	10:00 am ET
Location:	Virtual
Webcast registration:	https://lifescievents.com/event/medigene/

Following the call, an archived webcast will also be accessible on the Investor & Media section of the Medigene website https://www.medigene.com/investors-media/reports-presentations

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About Medigene

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell therapies to effectively eliminate cancer. Its end-to-end technology platform, built on multiple proprietary and exclusive product development and product enhancement technologies, allows Medigene to create best-in-class differentiated, T cell receptor engineered T cell (TCR-T) therapies for multiple solid tumor indications that are optimized for both safety and efficacy. This platform provides product candidates for both its in-house therapeutics pipeline and partnering. For more information, please visit www.medigene.com

About Medigene’s End-to-End Platform

Medigene’s immunotherapies help activate the patient’s own defense mechanisms by harnessing T cells in the battle against cancer. Medigene’s end-to-end platform combines multiple exclusive and proprietary technologies to create best-in-class TCR-T therapies. The platform includes multiple product enhancement technologies, (e.g., PD1-41BB Switch Receptor, CD40L-CD28 Switch Receptor, Precision Pairing) and development optimization technologies (e.g., Allogeneic-HLA (Allo-HLA) TCR Priming) to aid the development of differentiated TCR-T therapies. Partnerships with multiple companies including BioNTech, 2seventy bio, and Hongsheng Sciences, continue to validate the platform’s assets & technologies.

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.

About KRAS

KRAS (Kirsten rat sarcoma viral oncogene homologue) belongs to the group of small so-called Guanosine-5'-triphosphate (GTP)-binding proteins, known as RAS-like GTPases. Under physiological conditions KRAS tightly regulates cell proliferation and survival.

In cancer, KRAS is found frequently altered, in a wide variety of often fatal solid cancer types like pancreatic ductal adenocarcinoma, non-small-cell lung cancer, and colorectal cancer. Mutations in the KRAS gene result in the creation of neoantigens which drive uncontrolled proliferation of cancer cells. These mutations within the KRAS gene are unique to cancer cells and absent in healthy normal tissue, making KRAS an attractive target for TCR-T therapies. T cell receptor engineered T cell therapies offer a promising approach to targeting these mutations and addressing the challenges posed by solid tumors. Unlike CAR-T cells, which require surface antigens for recognition and may have limitations in target accessibility, TCR-T cells recognize a broader range of targets including intracellular proteins like neoantigens. This unique ability makes TCR-T therapies particularly well-suited for targeting KRAS mutations and other challenging neoantigens.

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

Pamela Keck
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

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