HyperAcute Pancreas - Biotech's 5 key attacks on pancreatic cancer

Drug: HyperAcute Pancreas
Company: NewLink Genetics
Phase: Phase III
Type: Vaccine

Scoop: NewLink Genetics is attempting to harness the immune system to attack pancreatic cancer with a late-stage vaccine called HyperAcute Pancreas cancer immunotherapy. The Ames, IA-based developer is conducting a Phase III trial to evaluate its vaccine in approximately 700 Stage I and Stage II pancreatic cancer patients. And NewLink has secured FDA Fast Track and Orphan Drug designations for adjuvant treatment of pancreatic cancer after surgeries to remove tumor tissue.

HyperAcute Pancreas is made up of equal doses of two separate, non-patient specific pancreatic cancer cell lines genetically engineered to express an enzyme called α-Ga. The enzyme isn't found in human pancreatic cancer cells, but NewLink's genetically engineered pancreatic cancer cells do share some molecules with the natural form disease. NewLink believes that the body will attack the genetically engineered cells, and in the process train the immune system to recognize and destroy the naturally occurring version of the disease.

NewLink kicked off its late-stage trial of HyperAcute Pancreas in May 2010 after a 70-patient Phase II trial of the vaccine combined with the standard of care turned in promising results. The study met its primary objective with an established median disease free survival of 14.2 months, NewLink disclosed in an SEC filing. Additionally, the trial met the secondary endpoint of overall survival; 86% of those who'd received the vaccine were alive after one year. Patients on the highest dose of the treatment demonstrated a median disease-free survival of 15.3 months.

As of Sept. 1, 161 patients were enrolled in the late-stage study at 52 sites in the U.S.; the company expects to fully enroll the Phase III trial by 2013. The vaccine is also in development for melanoma and lung cancer.

HyperAcute Pancreas - Biotech's 5 key attacks on pancreatic cancer
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