NewLink, AstraZeneca Sign Immuno-oncology Clinical Collaboration Deal

(RTTNews) - NewLink Genetics Corp. (NLNK) announced Monday that it has entered into a clinical collaboration agreement with AstraZeneca (AZN, AZN.L). The deal is to evaluate the combination of indoximod, NewLink Genetics' small molecule IDO pathway inhibitor, and durvalumab, AstraZeneca's anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy for patients with metastatic pancreatic cancer.

Durvalumab (Imfinzi), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.

The company said the primary objective for this randomized placebo-controlled, Phase 2 study is to evaluate the efficacy and safety of the immuno-oncology-based combination compared to gemcitabine/ABRAXANE alone.

Patients will also be enrolled into a smaller cohort evaluating the combination of durvalumab with gemcitabine/ABRAXANE.

The Phase 2 trial will be funded equally by both companies, with NewLink Genetics serving as the study sponsor. NewLink said its share of the aggregate expense of the trial is not expected to have a material effect on its financial position.

Imfinzi received accelerated approval from the US Food and Drug Administration for previously treated patients with advanced bladder cancer and is under review in Canada and Australia for similar use.

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.