BETHESDA, Md., Nov. 17, 2016 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today 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."
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients. GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a Phase I/II trial with DCVax-Direct for inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has received approval of a 5-year Hospital Exemption for the treatment of all gliomas (primary brain cancers) outside the clinical trial.
About MSD Sharp and Dohme GmbH
MSD Sharp and Dohme GmbH is the German subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, a leading healthcare company that discovers, develops, manufactures and markets a wide range of innovative pharmaceutical products to improve human health and animal health. It focuses on several key therapeutic areas, including Cardiovascular, Diabetes, Immunology, Infectious Disease, Oncology and Women's Health. It also has a strong pipeline in oncology with pembrolizumab (Keytruda®) being the most advanced pharmaceutical product.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks and uncertainties related to the actions and decisions of Nasdaq, the Company's ongoing ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process including the actions and decisions of the FDA and other regulators, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing and expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.