NorthWest Biotherapeutics Inc (NWBO)

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Institute of Immunology at Mainz had webpage updates last November. What would happen if the trial on colorectal cancer is real?

https://www.unimedizin-mainz.de/immunologie/en/overview.html
https://www.unimedizin-mainz.de/immunologie/en/research.html
https://web.archive.org/web/20241105023519/https://www.unimedizin-mainz.de/immunologie/en/research.html

Core Research
The research activities realized at the Institute of Immunology concern various aspects of the induction of innate and adaptive immune responses. As part of our investigations of the innate immune system we analyze the function and regulation of mast cells and neutrophils. Of special interest are the consequences of tissue-specific interactions of these cells, for example in the skin, with members of the adaptive immune system, e.g. T cells. These studies are paralleled on one hand by research activities addressing the role of different populations of dendritic cells in the skin and in peripheral lymphoid organs where tolerance and induction of antigen-specific immunity is established. On the other hand, we are interested in the role of different cytokines in the differentiation of T cells and the function of regulatory T cells. The analysis of T cell differentiation is focused on transcriptional regulation of the development and function of different T helper cell populations, such as Th2, Th9 and Th17 cells. Furthermore, we study the function of regulatory T cells which play an essential role in maintaining the immunological tolerance in the periphery. Of special interest is the influence of this subpopulation on the activity of dendritic cells and also CD4 and CD8 positive T cells. Malfunctions of regulatory T cells are therefore associated with the development of allergic and autoaggressive diseases as well as tumors and chronic infections. For this reason, studies on the understanding of the inhibitory mechanisms of regulatory T cells including surface molecules and molecular pathways play a central role.

In addition, we perform studies leading to a better understanding of antigen processing and presentation of MHC Class I ligands in tumors and virus-infected cells as well as the induction of antigen-specific immune responses. Through local but also international cooperations, we are particularly interested in the correlation of protein expression and degradation rates and the production of MHC class I ligands.

https://nwbio.com/nw-bio-announces-phase-ii-clinical-trial-program-combining-dcvax-l-and-pembrolizumab-keytruda-for-colorectal-cancer/

The trial will be conducted as an investigator-initiated trial led by the University of Mainz, thereby substantially reducing the costs involved. NW Bio will provide the DCVax-L products and MSD Sharp & Dohme GmbH will provide the Pembrolizumab. (MSD Sharp & Dohme is the operating name used by U.S.-based Merck & Co., Inc. outside the U.S. and Canada.) All of the parties contributed to and approved the novel trial design.

This trial will combine a broad spectrum personalized vaccine (DCVax®-L) with a highly targeted checkpoint inhibitor drug (Pembrolizumab). In contrast, most combination trials to date have combined two specifically targeted agents, with no broad spectrum agent included.

Colorectal cancer represents a major unmet medical need. The number of new cases per year is second only to lung cancer, and colorectal cancer results in approximately 700,000 deaths per year in the Western world. Colorectal cancer is very heterogeneous and various therapies to date, including various immune therapies when used as a single agent, have been disappointing.

The UMC of Johannes Gutenberg University Mainz is a leading Center of Excellence for colorectal cancer, and especially liver metastases of colorectal cancer. The 1st Department of Medicine provides a wide range of treatments and conducts a variety of clinical trials, especially in gastrointestinal oncology.

After the parties complete certain preparatory activities, including obtaining regulatory approvals, the Phase II trial will treat patients for up to 6 months with DCVax®-L and Pembrolizumab, followed by long-term follow-up regarding patient survival.

Linda Powers, CEO of NW Bio, noted that, “More than 2 years of planning and work have gone into developing this Phase II trial program. We are excited to work with a leading team to test the potential synergies of combining broad spectrum DCVax-L and targeted Pembrolizumab to treat a heterogeneous and challenging disease such as metastatic colorectal cancer.”