About Medigene

Medigene AG, a biotechnology company, develops immunotherapies to target various forms of cancers. Segments The company operates through Immunotherapies and Other Products segments. Immunotherapies segment T cell Receptor-based Adoptive T cell Therapy (TCRs) The company’s TCR therapies intend to arm the patient’s own T cells with tumor-specific T cell receptors. In July 2017, the company filed a clinical trial authorization application to begin the first clinical trial in this field with its proprietary T cell receptor-modified T cells as an immunotherapy to treat a range of blood cancer indications. The CTA for the company’s first TCR-candidates MDG1011 was submitted to the German regulatory authority Paul-Ehrlich-Institute and final approval for the study has been granted in 2018. The company intends to treat the first patients in this phase 1/1Iclinical trial in the first half of 2018. In March 2017, the company announced details around this TCR clinical trial. The phase 1/1I clinical trial would explore the safety and feasibility of the therapy and treat patients with advanced hematological cancer diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome and multiple myeloma. In October 2017, the company and its academic partners also published a method to identify T cell receptors against viral antigens in the scientific journal ‘Human Gene Therapy’. The article describes a method to identify T cell receptors for new and immunodominant peptide-MHC (pMHC: peptide major histocompatibility complex) molecules of cancer cells and shows how a platform, such as the company also serves to identify TCRs against oncogenic viruses, such as the human papillomavirus. Dendritic Cell (DC) vaccines With the company’s advanced immunotherapy, the company develops new generation antigen-tailored DC vaccines. DCs could take up antigens, process them and present peptides on their surface in a form that could induce antigen-specific T cells to mature and proliferate. At the end of November 2017, the company completed patient recruitment for the clinical trial with DC vaccines in AML. Various planned patients have been enrolled in the phase 1/1Istudy. The completion of the study is expected in 2019 after a treatment period of two years for various patients. The primary objective of the study is to assess safety and feasibility of the active immunotherapy with the company’s DCs. Secondary objectives of the study are induction of immune responses, overall survival, progression free survival, control of minimal residual disease and clinical response/time to progression. In April 2017, the company’s academic partner, Oslo University, presented an update on clinical data from compassionate use of a DC vaccine utilizing its DC vaccine technology. Results of five AML patients in morphological remission after incomplete induction/consolidation chemotherapy treated with DCs targeting WT (Wilms tumor)-1 and PRAME (preferentially expressed antigen in melanoma) were presented at the American Association for Cancer Research Annual Meeting in Washington, D.C., U.S. The results show that in four out of five AML patients, toll-like receptor-polarized DC vaccination induced or supported specific T cell responses. Three patients continue to be in complete remission after 21, 25 and 33 months respectively, following suboptimal primary chemotherapy. Immune responses for those patients were presented. T cell-specific Monoclonal Antibodies (TABs) The company’s therapy approach using TABs serves to generate monoclonal antibodies that could recognize and differentiate between different T cells. These antibodies are intended to remove unwanted T cells from the body to treat T cell-induced diseases, such as T cell leukemia or various autoimmune diseases. This platform is used to produce and characterize monoclonal antibodies that distinguish different T cells. Proof-of-technology was established in preclinical experiments. Other products segment Veregen The company generates revenue from royalties, product sales, and milestone payments with Veregen, a drug for the treatment of genital warts. In December 2017, the company sold the U.S.-rights for Veregen to Fougera Pharmaceuticals, Inc. thereby completing its repositioning as an immunotherapy company. RhuDex In 2014, the company concluded a global license agreement with the pharmaceutical company Dr. Falk Pharma GmbH for the development and marketing of the drug candidate RhuDex in the hepatology and gastroenterology indications. Falk Pharma assumes responsibility and various costs relating to the future development and marketing of RhuDex in these therapeutic areas. Strategy The company’s strategy is to develop its own therapies and to commercialize them, starting with hematological malignancies. Research and Development In the year ended December 31, 2017, the company’s research and development expenses were €14,877k. History The company was founded in 1994.