Category: Tech / Sci / May 2, 2013 2:09 PM EDT
Northwest Biotherapeutics, Inc (NYSE: NWBO), a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer, is leading the way to a new approach to cancer treatment, adding years of survival and doing so without toxic side effects at lower cost than pricier new cancer drugs. Northwest Biotherapeutics CEO and Chairman Linda F. Powers spoke about how cancer research is moving forward.
One-hundred cancer specialists from around the world made headlines recently after they jointly appealed to the major pharmaceutical companies to curb the skyrocketing pricing of cancer drugs at $100,000 per year and up.
NW Bio is cutting costs while adding years of survival, and doing so without poisonous side effects, and make these new breakthrough treatments available to all patients.
High priced cancer drugs are delivering very little benefits and most of them come with serious toxic side effects, according to NW Bio.
The company’s new approach to fighting cancer at a cheaper cost involves personalized immune therapies, mobilizing a patient’s own immune system to attack his or her cancer. These personalized immune therapies can apply to all types of solid tumor cancers, and there are two main versions: one for tumors that can be surgically removed, and one for tumors that are inoperable.
These personalized immune therapies are made from two key ingredients: the master cells of the immune system, called “dendritic cells,” which were the subject of the Nobel Prize in 2011, plus biomarkers of the patient’s tumor. The immune cells are obtained through a blood draw from the patient, and are then activated and “educated” to recognize the patient’s tumor biomarkers, making the immune cells into a powerful vaccine that naturally mobilizes the rest of the immune system to attack the cancer, and only the cancer, without poisoning or damaging the normal cells in the body.
The vaccine, composed of these activated, “educated” master immune cells, is administered as a simple shot under the skin in the upper arm, like a flu shot. For inoperable tumors, the vaccine is injected directly into one or more tumors.
The first version is already in late stage, Phase III, clinical trials for the first cancer: brain cancer (same type as Senator Ted Kennedy had). In the prior Phase I/II trials for brain cancer, the immune therapy mobilized a long-lasting immune response that delayed the typical time for tumor recurrence from 7 months to 2 years, and extended survival from 14 months to 3 years or more (with some patients living 4 to 6 years or more, and 2 patients having exceeded 10 years).
The second version, for inoperable tumors, is about to start clinical trials for all solid tumor cancers. In the pre-clinical animal studies, when the immune therapy was injected into some of the tumors, it mobilized a strong body-wide immune response that cleared all of the tumors in nearly all of the animals (including the tumors that were not injected).
The treatment schedule involves three treatments in the first month, then several boosters spaced over the rest of year one, and then treatments twice a year for maintenance – a total of eleven treatments over three years.
Both versions of the immune therapy, for surgically removable tumors and for inoperable tumors, are made in a single manufacturing batch which takes just 7-8 days, and which produces at least 3 years or more of doses for that patient all at once. The doses are then frozen until needed, and the frozen shelf life has been proven. The batch manufacturing process greatly reduces costs, even though the product is personalized, and will enable the treatment to cost less than other new, high-priced cancer drugs.
According to NW Bio, the results of the immune therapy treatments have been striking and consistent. In Phase I/II trials in such diverse cancers as brain, prostate and ovarian cancers, average life extensions were measured in years instead of months. And over eighty percent of all patients treated with the immune therapy showed clinical benefits. For example, they lived longer than the typical survival with standard of care today. With many cancer drugs, only 25-30% of patients who take them show positive responses.
NW Bio is further along with more immune therapy products for multiple cancers than others in this new field of cancer immune therapies: A 312-patient Phase III clinical trial, with the immune therapy for solid tumors that can be surgically removed, is already under way at 45 medical centers all across the US and starting soon at up to 30 hospitals in Europe, and is expected to finish next year. A large Phase I/II trial with the immune therapy for all types of inoperable solid tumors is expected to begin within the next couple weeks at major institutions in the US, and show results over the coming months of this year. The key endpoint being measured is regression (shrinkage or elimination) of the inoperable tumors – which may be seen as soon as 1 to 2 months after treatment.