Northwest Biotherapeutics (NWBO) Announces DCVax-L + Keytruda Combo Phase in Colorectal Cancer

November 17, 2016 8:16 AM EST
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Northwest Biotherapeutics (Nasdaq: NWBO) joined the University Medical Center (UMC) of the Johannes Gutenberg University Mainz in Germany in announcing a Phase II clinical trial program combining DCVax-L and Pembrolizumab (Keytruda) for colorectal cancer with liver metastases.

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."

The University of Mainz's own announcement can be found on their website at

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