HyperAcute Pancreas

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Vaccine: HyperAcute Pancreas (algenpantucel-L)
Company: NewLink Genetics
Target: Pancreatic cancer

NewLink Genetics ($NLNK), a newly public biotech company, is developing HyperAcute Pancreas (algenpantucel-L), a cell-based vaccine against pancreatic cancer, in Phase III trials in the U.S. Rather than using the personalized approach as exemplified by Dendreon's Provenge (sipleucel-T), algenpantucel-L is an off-the-shelf vaccine based on two allogeneic (non-self) pancreatic cancer tumor cell lines. These were chosen to cover a broad spread of pancreatic cancer antigens, and are engineered to produce alpha (1,3) galactosyltransferase (α-GT), which boosts the immune response against the patient's pancreatic tumor.

In a Phase II trial of high-risk patients with resected pancreatic cancer (removal of the tumor post-cancer surgery), given algenpantucel-L along with standard therapy, there was an improvement in the number of patients who were disease-free at one year, as well as a rise in overall survival at one, two and three years compared with standard chemotherapy. As an added bonus, the benefits seemed to improve over time in some patients. For the few patients who relapsed, further chemotherapy put them into remission still ongoing at 6 to 36 months.

The vaccine was given as an intradermal injection in up to 12 treatments over 6 months, followed-up with 6 maintenance treatments over a further 6 months.

NewLink Genetics has an ongoing study of algenpantucel-L in resected pancreatic cancer patients, and has launched an additional open-label, randomized Phase III study in patients with borderline resectable or locally advanced unresectable pancreatic cancer, where patients will receive standard of care FOLFIRINOX (leucovorin calcium, fluorouracil, irinotecan, and oxaliplatin) alone or in combination with algenpantucel-L. The study will look at the effect of the treatment on overall survival, progression-free survival, and immunological response.

In a tough period for IPOs, NewLink Genetics floated in 2011, netting $43.4 million, and is currently trading around $15.