Immunotherapy is considered to be a promising new option for the treatment of cancer. For decades the treatment of cancer was solely based on the operative removal of tumors, radiotherapy and chemotherapy. These conventional treatment methods generally lead to a considerable improvement in illness initially, but this improvement is often short-lived and such treatment is often unable to stop the progression of cancer. In addition, patients suffer serious and significant side effects when undergoing these treatments. In this age of modern medicine and biotechnology, hormone therapy and treatment through the inhibition of signal transmission pathways are more targeted approaches with considerably improved success rates.

Cancer arises from genetic mutations that accumulate in cells which lead to uncontrolled cell growth and prevent or impede the ability of the immune system to recognize and combat this process. The tremendous increase in knowledge on how the human immune system functions over the last two decades and subsequent opportunities to directly influence it in a specific way have resulted in innovative treatment strategies for cancer, which all come under the umbrella term of immunotherapy. These therapeutic approaches activate, stimulate, influence and optimize the natural immune response in order to allow the immune cells of the body to successfully combat cancer long term.

T cells play a major role in the immune response of humans. These cells in the immune system are ultimately effector cells which directly combat, kill and eliminate tumor cells. The specific activation, stimulation, strengthening and improvement of T cell-specificity is a modern therapy approach which should allow for effective, long-lasting treatment of cancer.

T-cell receptor-based adoptive T-cell therapy (TCR-Ts)

Medigene’s TCR-T platform in the field of immunotherapy aims to arm 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 form of immunotherapy aims to overcome the patient’s tolerance to cancer cells and tumor-induced immunosuppression, by activating and modifying the patient’s T cells outside the body (ex-vivo). Large numbers of specific T cells to fight the tumor are made available to patients within a short period of time.

In the context of this platform Medigene is developing a comprehensive pipeline of recombinant T-cell receptors. A good manufacturing practice (GMP)-compliant process for their combination with patient-derived T cells is already established. It has paved the way for the clinical development of our proprietary TCR-Ts which has started with the clinincal trial of Medigene's TCR-T therapy MDG1011 in March 2018.


DC vaccines (DCs)

With Medigene’s most advanced platform the Company develops new generation antigen-tailored dendritic cell (DC) vaccines. Dendritic cells can take up antigens, process them and present them on their surface in a form that can induce antigen-specific T cells to mature and proliferate. In this way T cells recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of scientists at Medigene has developed new, rapid and effective methods for generating autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumor antigens to treat different forms of cancer.

Medigene is conducting a Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML) with DC vaccine. The phase II part of this trial is ongoing. All necessary 20 patients have been enrolled into the trial at the end of 2017.


T-cell-specific monoclonal antibodies (TABs)

Medigene’s third product platform serves to generate monoclonal antibodies which are able to recognize different T cells (TABs = T-cell-specific AntiBodies). These TABs are intended to remove unwanted T cells from the body in order to treat T-cell-induced diseases such as T-cell leukaemia or various autoimmune diseases. This platform is used to produce and characterize monoclonal antibodies which are able to distinguish between different T cells. Proof of technology was established in preclinical experiments.

Preclinical development of the T-cell-specific monoclonal antibodies (TABs) will be continued with the aim of achieving preclinical proof of principle.