NewLink Genetics has launched a Phase III open-label study of algenpantucel-L immunotherapy in patients with borderline resectable or locally advanced unresectable pancreatic cancer.
The multi-institutional study is expected to enrol and randomise 280 subjects and patients (1:1) with standard of care Folfirinox plus or minus algenpantucel-L (HyperAcute-Pancreas) immunotherapy.
The evaluation of the overall survival is the primary endpoint, while the secondary objectives include evaluation of progression free survival and immunological response.
NewLink chief executive officer Dr. Charles Link said the company is initiating an additional Phase III trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer.
"The successful expansion of algenpantucel-L into a market segment for locally advanced disease would potentially more than double the patient population who might benefit from this immunotherapy treatment," Dr. Link added.
The algenpantucel-L immunotherapy product candidate consists of a group of two allogeneic pancreatic cancer tumour cell lines that were modified to express Alpha-Gal. Every modified cell line is grown in large cultures, harvested, irradiated and packaged, according to the company.
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NewLink Genetics chief medical officer Dr. Nick Vahanian said at present more than 70 major cancer centres are enrolling patients in the ongoing trial for resected pancreatic cancer patients.
"We believe these relationships will enable us to efficiently implement this new Phase III clinical trial," Vahanian added.