Dentritic Cell Treatment Developed for Inoperable Solid Tumors

Northwest Biotherapeutics (NW Bio; Bethesda, MD, USA), a biotechnology company that develops customized immune therapies for cancer, reported that it is in late stage discussions with medical centers in the United States and Europe to continue with a phase I/II clinical trial with the company’s agent, DCVax-Direct, for all types of solid tumor cancers (i.e., cancers in any tissues). The company previously received US Food and Drug Administration (FDA) approval of the clinical trial.

A large number of patients with a variety of cancer types (including lung, colon, pancreatic, liver, ovarian, head and neck, and others) are faced with this situation, because their tumors are already locally advanced or have begun to metastasize by the time symptoms develop and the patients seek treatment. For these patients, the outlook today is bleak and survival remains quite limited.

DCVax-Direct is administered by direct injection into a patient’s tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. The agent can also be injected into tumors in virtually any location in the body: not only tissues at or near the surface of the body but also, with ultrasound guidance, into interior tissues.

The phase I/II trial with the compound will treat 36 patients in two parts. In part 1, 24 patients with any type of solid tumor cancer will be treated in groups with increasing dose levels. Then, in part 2, an additional 12 patients with any selected cancer will be treated with the optimal dose. When DCVax-Direct was administered in preclinical animal studies, existing tumors regressed. Importantly, the tumors that regressed included not only tumors that were injected with the compound but also tumors on the opposite side of the animal’s body that were not injected, indicating a systemic immune response. Moreover, when the animals were then challenged (injected) with cancer cells, the animals did not re-develop cancer, indicating immune memory. Significantly, the company’s proprietary activation step for the dendritic cells appeared to be crucial for these findings.

“This broad phase I/II trial, allowing DCVax-Direct to be used for all solid tumor cancers, is a very significant development for us and will enable us to make faster and more efficient clinical progress for multiple cancers than would usually be the case,” commented Linda Powers, CEO of NW Bio. “Based upon the preclinical studies showing regression of existing tumors, DCVax-Direct may offer a much needed new treatment option for patients suffering with inoperable tumors today.”

DCVax-Direct is based upon the same platform technology as the company’s first two major product lines (DCVax-L and DCVax-Prostate). This technology utilizes the patient’s own dendritic cells--the master cells of the immune system. Each product line involves two major elements: the dendritic cells (which are activated to activate the immune system to fight the patient’s cancer), and biomarkers of the patient’s tumor (which identify the targets for the immune system to attack).

For DCVax-Direct, the dendritic cells are activated in a special proprietary approach, to enable them to be directly injected into the patient’s tumors, and to capture the biomarkers of the tumors onsite in the tumor. The “educated” dendritic cells then go on to mobilize the immune system to attack any tumors bearing those biomarkers.

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