Northwest Biotherapeutics, a Bethesda, Md.-based biotechnology company developing DCVax personalized immune therapies for cancer, has initiated a collaboration with U.K.-based cancer institutions Sarah Cannon Research U.K. and Leaders in Oncology Care (LOC) on a phase I/II trial with DCVax-Direct for metastatic colon cancer.
DCVax-Direct offers an important potential new treatment option for colon cancer patients whose cancer has spread and is no longer operable. DCVax-Direct is specifically designed to treat inoperable cancers in various tissues through direct injection into the tumors. It can be injected into any number of tumors, and virtually any location in the body (with imaging guidance for interior tissues).
Northwest Bio has received FDA approval for a 36-patient phase I/II trial in any solid tumor cancers. The primary endpoint of the trial will be a measure of tumor response (regression) in patients' existing, established tumors. As part of the collaboration with Sarah Cannon Research UK and LOC, Northwest Bio will pursue U.K. regulatory approval of phase I/II trials.
DCVax-Direct offers a potentially significant new treatment for inoperable metastatic cancers such as colon cancer, involving multiple tumors. It is comprised of the patient's own dendritic cells, which are activated in special proprietary manner and directly injected into the patient's tumors, to pick up the tumor biomarkers onsite in the tumors and mobilize the immune system to attack any tumors bearing those biomarkers.
In pre-clinical animal studies with multiple tumors, regression was observed not only in the tumors that were injected with DCVax-Direct, but also tumors on the opposite side of the animal's body which were not injected, indicating a systemic immune response. Further, when the animals were subsequently injected with cancer cells, the animals did not re-develop cancer, indicating immune memory.
"Partnering with major institutions such as Sarah Cannon and LOC will enable us to benefit from their extensive oncology experience and broad reach, and will help accelerate our clinical trials with DCVax-Direct," said Linda Powers, CEO of Northwest Bio. "We are very pleased to partner with them for this program."
Sarah Cannon Research UK is the London-based arm of Sarah Cannon Research Institute (SCRI), a global strategic research organization focusing on advancing therapies and accelerating drug development. Leaders in Oncology Care (LOC) was formerly known as the London Oncology Clinic, is a private cancer center well known for its patient-centered focus.