NewLink Genetics Corporation, a biopharmaceutical company focused on discovering, developing, and commercializing immunotherapeutics to treat cancer, has formed an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink’s IDO pathway inhibitor. The parties also entered into a research collaboration for the discovery of next generation IDO/TDO compounds.

Under the terms of the agreement, NewLink will receive an upfront payment of $150 million. NewLink will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech. Genentech will fund future research, development, manufacturing, and commercialization costs. Genentech will also provide research funding to NewLink for support of the research collaboration. NewLink will continue to pursue development activities associated with NLG919 in combination with its HyperAcute vaccine platform.

NewLink will retain the option for co-promotion rights for NLG919 and potential next generation IDO/TDO compounds in the U.S. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4, PD-1, and PD-L1 that represent potential breakthrough approaches to cancer therapy. The IDO pathway regulates immune response by suppressing T-cell activation, which enables local tumor immune escape. Recent studies have demonstrated that the IDO pathway is active in many cancers, both within tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby this pathway promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, the IDO pathway may facilitate the survival, growth, invasion, and metastasis of malignant cells whose expression of TAAs might otherwise be recognized and attacked by the immune system.

NewLink has a number of active programs directed at synthesizing inhibitors to the IDO pathway and additionally has discovered novel tryptophan-2,3-dioxygenase (TDO) specific inhibitors that are potential anti-cancer compounds which could function individually or in combination with IDO inhibition.

Source: NewLinks Genetics