Medigene AG: Medigene Signs Exclusive License Agreement with Leiden University to Develop Novel T Cell Receptor

Martinsried/Munich (pta033/12.11.2018/18:51 UTC+1) TCR targeting HA-1 antigen for hematological and solid tumors provides initial clinical safety and tolerability data

Medigene AG (FSE: MDG1, Prime Standard, SDAX) today announced that it has entered into an exclusive license agreement with Leiden University Medical Center (LUMC), the Netherlands, for worldwide rights to develop, manufacture, and commercialize an HA-1-specific T cell receptor (TCR) as a targeted immunotherapy for cancer.

The TCR specific for the minor histocompatibility antigen HA-1 was developed by LUMC and tested for preliminary safety and tolerability in a Phase I clinical trial involving five patients. HA-1 is a well-characterized antigen expressed in cells of the hematopoietic system, in leukemia and lymphoma cells, as well as expressed in various solid tumors.

Dr Kai Pinkernell, CMO and CDO of Medigene , said: "We are excited to have licensed this HA-1-targeting T cell receptor, which has already undergone early clinical testing, to complement Medigene's preclinical and clinical development program. Scientists from LUMC and Medigene have had a longstanding shared scientific interest and exchange on HA-1 and we look forward to our future interactions. Our own extensive research and development for the HA-1 antigen confirms the potential of this approach in general and this TCR candidate in particular. Its potential applicability in both liquid and solid tumors makes strategic sense within our growing internal pipeline."

Mirjam H.M. Heemskerk, PhD, Associate Professor of the Department of Hematology at the Leiden University Medical Center , said: "Medigene is an ideal partner to further advance this promising TCR candidate given their deep scientific expertise, broad development work and strong focus on TCRs. We share a common vision of developing T cell receptor therapies to offer seriously ill cancer patients much-needed treatment alternatives."

Under the terms of the agreement, Medigene will receive the exclusive worldwide development and commercialization rights to the HA-1-specific TCR developed by LUMC. In return, LUMC will receive a one-time payment along with certain milestone payments. Upon commercialization, LUMC is eligible for royalties in the low-single digit percentage range. Confidentiality was agreed regarding further financial details.

Terms of the deal do not materially impact Medigene's financial guidance for the balance of the year 2018.

About HA-1: The HA-1 antigen has been extensively studied by Medigene's research team. It is a clinically validated T cell target used in stem cell transplantation (SCT). HA-1, as a single nucleotide polymorphism (SNP), is easily detected by a PCR method and shows a well-characterized tissue expression pattern.

About Medigene's TCR-Ts: Medigene's first TCR-T candidate, MDG1011, is in a Phase I/II clinical trial started in 2018.
The TCR-T 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-T therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR-T) therapy.
Medigene is establishing a pipeline of recombinant T cell receptors and has a collaboration with bluebird bio, Inc. for the development of six TCR-Ts.

About Leiden University Medical Center:
As a center of medical innovations the Leiden University Medical Center (LUMC) strives towards an internationally recognized leading role in the improvement of quality of health care. The core businesses of LUMC are patient care, research, education and training. The clinical and laboratory research at the department of Hematology of the LUMC has led to the discovery of TCRs with high specificity for tumor cells that now can be explored in clinical studies. The research of the Department of Hematology aims to translate basic research achievements into clinical applications in the field of hematopoietic stem cell transplantation and immune therapy of cancer. The establishment of the license agreement has been facilitated by knowledge exchange office Luris, on behalf of LUMC.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene focuses on the development of personalized T cell-based therapies, with projects currently in preclinical and clinical development.

For more information, please visit http://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.

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