Brain Cancer Vaccine Candidate Production Launches in the U.K.

Maryland-based Northwest Biotherapeutics announced production has begun of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, U.K.

This milestone follows approval by the U.K. Medicines and Healthcare Products Regulatory Agency of a license for manufacture of GMP cell therapy products for compassionate use cases and approval by the Human Tissue Authority of a license for collection and processing of human cells and tissues for medical purposes.

The Company is developing DCVax® personalized immune therapies for solid tumor cancers.

The Company’s lead program is a 331-patient Phase III clinical trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM).

GBM is the most aggressive and lethal form of brain cancer and is an “orphan disease.”

According to the U.S. NIH, GBM is a primary central nervous system cancer with an annual incidence of approximately 3.19/100,000, with a very poor prognosis, and a very short median survival time of about 14.6–16.6 months.

This Phase III trial reached data lock, and the Company is actively continuing to move toward the announcement of top-line data.

The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer with the University of Pennsylvania.

The Company has also developed DCVax®-Direct for inoperable solid tumor cancers.

It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials.

Northwest Biotherapeutics is located in Bethesda, MD, and is led by its CEO Linda F. Powers.