Medigene Unveils UniTope and TraCR: Revolutionizing TCR Detection and Tracking

Medigene AG, a leading oncology platform company, has made a significant breakthrough in the field of T cell receptor (TCR)-guided therapies with the introduction of UniTope and TraCR, a universal detection system for 3S (specific, sensitive, and safe) recombinant TCRs (rTCRs). This innovative technology was presented at the American Society of Gene & Cell Therapy (ASGCT) conference held in Philadelphia, PA, on October 16-17, 2024.

UniTope and TraCR represent a major advancement in the detection and tracking of rTCRs, enabling precise monitoring and quality control processes. The system consists of a six-amino-acid peptide, UniTope, which is integrated directly into the rTCR constant region. This unique identifier allows for standardized tracking and enrichment of rTCR-T cells, even in complex gene transfer systems. Additionally, an antibody, TraCR, is designed to specifically recognize and bind to the UniTope sequence, enabling precise tracking of the tagged TCRs.

In vitro data demonstrated that insertion of the UniTope tag 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 the functionality of the rTCR. Furthermore, safety assessments verified that UniTope-modified rTCRs exhibited the same high safety profile as their unmodified counterparts, with no unintended recognition or cytotoxic activity against 16 different types of healthy cells tested.

The use of UniTope and TraCR technologies will significantly enhance Medigene's 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. This universal detection system is highly versatile and can be applied across various therapeutic modalities, including T cell receptor engineered T cell therapies, TCR-guided T cell engagers, and TCR-NK cell therapies.

In conclusion, Medigene's presentation of UniTope and TraCR at ASGCT 2024 marks a significant milestone in the development of TCR-guided therapies. This innovative technology has the potential to revolutionize the detection and tracking of rTCRs, paving the way for more effective and safer cancer treatments. As Medigene continues to advance its End-to-End Platform, the integration of UniTope and TraCR will undoubtedly contribute to the company's ongoing success in the field of immuno-oncology.