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Home>NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer

NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer

NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer

09/25/2017

NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer

Phase 2, randomized, double-blind, placebo-controlled trial of indoximod in combination with durvalumab, an immune checkpoint inhibitor, along with gemcitabine/ABRAXANE ® (nab-paclitaxel) and durvalumab with gemcitabine/ABRAXANE ® versus gemcitabine/ABRAXANE ®

NewLink Genetics Corporation (Nasdaq: NLNK) today announced that it has entered into a clinical collaboration agreement with AstraZeneca 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.

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 Genetics’ share of the aggregate expense of the trial is not expected to have a material effect on its financial position.

“We are pleased to initiate a joint immuno-oncology clinical collaboration with AstraZeneca,” said Dr. Charles J. Link, Jr., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics. “As recent data have indicated, indoximod combinations with immunotherapy and chemotherapy show promise of improving outcomes for patients with multiple tumor types.”

About Durvalumab

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.

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