Pipeline Overview
HyperAcute® allogeneic (off-the-shelf) cancer cell-based immunotherapies:
NewLink has produced and tested the safety profiles of five different HyperAcute cancer immunotherapies designed to treat non-small cell lung cancer, pancreatic cancer, melanoma, prostate cancer, and breast cancer. At present our resources are mainly focused on advancing HyperAcute-Pancreas and HyperAcute-Lung immunotherapies through Phase 2 trials. We plan to initiate a pivotal trial of HyperAcute-Pancreas immunotherapy in early 2010. In line behind our two leading HyperAcute product candidates, HyperAcute-Melanoma immunotherapy has shown early promise in a small, physician-initiated Phase 2 study, and HyperAcute-Prostate immunotherapy yielded encouraging results in a completed Phase 1 study.
Beyond the current pipeline, NewLink's HyperAcute platform will readily support efficient design and development of additional products tailored for treatment of other cancer types.
Small molecule inhibitors of cancer immune escape pathways:
NewLink's formulation of D-1 methyl tryptophan (D-1MT) — an inhibitor of the indoleamine 2,3 dioxygenase (IDO) pathway — is being tested in two Phase 1 studies designed to assess its safety in humans. Our scientists are also engaged in research aimed at identification of next generation development candidates targeting the IDO pathway.