 HyperAcute® Vaccine Technology: NewLink Genetics’ approach for the treatment of cancer takes advantage of knowledge recently gained in the fields of organ transplant immunology, innate immunity, and genetics. The HyperAcute® technology platform is novel in its approach to the stimulation of the human immune system, in particular by exploiting a natural barrier that protects humans against infection by viruses and bacterial pathogens common to lower mammals. Humans have lost an enzyme that makes a particular galactose-containing carbohydrate that is present on all cells from lower mammals or viruses that bud from the cells of lower mammals. As a result, human have none of this carbohydrate on their cell surfaces. However, humans have developed a large amount of natural antibody to this carbohydrate. As a result, the human immune system will attack any cell that has this carbohydrate and destroy it. Therefore, any cancer vaccines containing this carbohydrate are rapidly recognized by the immune system as foreign and then destroyed. In the process, immune cells are educated to attack a patients own cancer cells. NewLink Genetics’ scientists have shown in small animal models of cancer that the immune systems responds after a HyperAcute® vaccination by attacking all similar cancer cells, even those that aren't expressing the carbohydrate.
Clinical Status: The Company currently has four active Investigational New Drug (IND) applications to pursue its product development goals and become a leader in advanced cancer vaccine development. Accordingly NewLink Genetics currently has four drugs that have successfully completed Phase I human clinical trials for lung cancer, melanoma, pancreatic cancer, and prostate cancer. These four trials have established that the drugs can be administered safely to critically ill patients with advanced cancer. The lung cancer trial was actually a small scale combined Phase I/II trial that evaluated lung cancer patients who had failed prior salvage chemotherapy. We are encouraged by the preliminary results of accordingly, the lung cancer vaccine has now been expanded to two larger scale Phase II trials, one in patients who have failed chemotherapy and in another trial where the vaccine is added to initial therapy for advanced lung cancer patients. Both of these trials initiated patient enrollment in 2007. Based on preliminary data for the Phase I trials in pancreatic cancer patients, a Phase II trial has been initiated for pancreatic cancer patients who are eligible to undergo surgical resection when first diagnosed.
|
