Medigene presents UniTope and TraCR a universal detection system for 3S recombinant TCRs at ASGCT 2024

Planegg/Martinsried, October 17, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, presented a universal detection system for 3S (specific, sensitive, and safe) recombinant TCRs (rTCRs), UniTope & TraCR, at the American Society of Gene & Cell Therapy (ASGCT) to be held October 16-17, 2024 in Philadelphia, PA in the US.

The presented poster “Seamless Integration of a Universal Epitope into Recombinant TCRs for Tagging and Tracking of TCR-T Cells Expressing 3S TCRs” will be made available after the conference on Medigene’s website: https://medigene.com/science/abstracts/

“We incorporate innovative technologies into our End-to-End Platform, including UniTope and TraCR, a universal detection system for any rTCR across multiple modalities. These two tools may ensure precise tracking and verification of recombinant TCRs contributing to safer and more effective dosing strategies in the development and administration of TCR-guided therapies,” said Dolores Schendel, CSO at Medigene. “Following the promising data previously presented at this year’s annual ESMO meeting for UniTope-modified rTCRs targeting NY-ESO-1/LAGE-1a, we are excited to now share our initial in vitro data for UniTope-modified rTCRs mKRAS G12V. The UniTope tag, when directly integrated, ensures that a unique identifier is always expressed in rTCR sequences. This represents a major improvement over existing techniques for detecting rTCRs in TCR-guided therapies. The use of UniTope and TraCR technologies will significantly enhance our ability to streamline quality control processes and generate highly accurate data for establishing the ideal drug dosage leading to significant cost and time reductions throughout development.”

The poster showcased the Company’s newly developed universal TCR tagging and tracking technology, UniTope & TraCR. Through bioinformatic analysis of T cell receptor beta variable sequences, a six-amino-acid peptide, UniTope, was identified, that is absent in natural TCR beta chains and exhibits low immunogenicity. Further, the UniTope sequence allowed each rTCR to be tagged, adaptable for multi-parameter flow cytometry and ideal for standardized tracking and enrichment of rTCR-T cells with a design that’s easy to implement in complex gene transfer systems. Alongside this, an antibody (TraCR) was also designed to specifically recognize and bind to this unique peptide sequence, enabling precise tracking of the tagged TCRs.

In vitro data demonstrated that insertion of the UniTope tag to rTCR-T cells targeting mKRAS G12V did not alter the expression or functionality of the rTCR. The tagged rTCRs maintained their normal biological activity, indicating that UniTope integration has no negative impact on functionality of the rTCR.
Additionally, safety assessments verified that UniTope-modified rTCRs exhibited the same high safety profile as their unmodified counterparts. These modified rTCRs did not show any unintended recognition or cytotoxic activity against 16 different types of healthy cells tested, ensuring that addition of the UniTope tag does not compromise safety.

Finally, UniTope-modified rTCRs demonstrated equivalent specificity, sensitivity, and safety characteristics compared to unmodified rTCRs. making them highly versatile for use across various therapeutic modalities, including T cell receptor engineered T cell therapies, TCR-guided T cell engagers, and TCR-NK cell therapies.

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering.

Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 received IND approval in Q3 2024 and is filing for CTA in Q4 2024.For more information, please visit https://medigene.com/

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 AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

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