Proof-of-principle achieved using healthy donors for the generation of neoantigen-specific TCRs
   Proof-of- technology established using automated high-throughput processes

MARTINSRIED/MUNICH, Germany I November 16, 2016 I Prof. Dolores Schendel, CEO and CSO of Medigene AG (MDG1, Frankfurt, Prime Standard), will present a new approach to develop T-cell receptors (TCRs) against neoantigens at the Neoantigen Summit 2016 in Boston (USA) on 16 November. Medigene has demonstrated the ability to utilize T cells from healthy donors together with a new automated system established in Medigene’s laboratories to identify and characterize TCR candidates against neoantigens for individualized cancer patient treatment.

Prof Dolores Schendel, CEO and CSO of Medigene, comments: “We are excited to announce that we are able to open new pathways in finding TCRs against neoantigens. I believe this approach addresses an important need for a personalized cancer treatment of the future and potentially offers an extension of our existing TCR platform. Our scientists were also able to demonstrate proof-of-technology with our new robotic platform, a functionally integrated and fully automated process that minimizes variability and replaces tedious bench work with automation in a rapid timeframe.”

In proof-of-principle studies, Medigene was able to deliver findings for both major immunotherapy routes the Company follows. Using Medigene’s dendritic cell technologies, it was possible to induce neoantigen-specific T-cell responses in cultures in vitro, thereby identifying the best suited tumor-specific mutations for use in DC vaccines to raise potent immune responses in patients. At the same time, Medigene’s approach provides an abundant source of TCRs for adoptive T-cell therapies. Medigene’s technologies yielded numerous T-cell clones and thereof identifiable TCRs against diverse neoantigens. Importantly, the TCRs were generated de novo from naïve T cells of healthy donors, bypassing the need for patient blood samples. In the future, the discovered TCRs could be potentially transferred into patient recipient T cells for subsequent adoptive T-cell therapy to combat tumor cells expressing the selected neoantigens.

Proof-of-technology was achieved for Medigene’s new robotic system, showing that the process and the automation steps allow the candidate identification of neoantigen-specific TCR candidates in approximately six weeks, saving time, reducing costs and minimizing variability in all phases of the TCR discovery processes.

The Neoantigen Summit gathers scientific and business leaders from pharma, biotech and academia to discuss challenges such as neoantigen selection, epitope design, appropriate delivery modalities and efficiency enhancement of downstream processing for personalized therapies. It takes place from 15 – 17 November in Boston and Prof Dolores Schendel will today present on the topic: “Are we Limited to Treatment of Tumors with High-Mutational Loads and Patients with Pre-Existing Neoantigen-Specific T Cells?” on Wednesday, 16 November. The abstract is available via Medigene’s website

About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).

TCR therapy is developed to target a greater number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a library of recombinant T cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells. The start of a clinical Phase I TCR investigator-initiated trial (IIT) with Medigene participation is expected for 2017. Medigene plans to commence its own first clinical TCR trial in 2017 and a second trial in 2018.

Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.

Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development. Medigene concentrates on the development of personalized T cell-based immunotherapies. For more information, please visit

SOURCE: Medigene