Genentech, NewLink deal could be worth more than $1B

AMES, Iowa—Biopharmaceutical company NewLink Genetics Corporation, which specializes in immunotherapeutics for patients with cancer, has announced an exclusive worldwide agreement with Genentech, a member of the Roche Group, for the development of NLG919, an IDO pathway inhibitor from NewLink. The two companies also established a research collaboration to discover next-generation IDO/TDO compounds.

Per the terms of the agreement, Genentech will pay NewLink $150 million up front, and NewLink will be eligible to receive more than $1 billion in milestone payments if all predetermined milestones are met. In addition, NewLink also stands to receive escalating double-digit royalties on potential commercial sales of multiple products by Genentech.

"This alliance enables us to accelerate and expand development of NLG919 while we continue to advance our other promising clinical and preclinical development programs," Dr. Charles Link, chairman and CEO of NewLink, said in a press release. "Genentech's oncology development expertise, commercial leadership and history of successful strategic alliances make it an ideal collaborator to bring the potential benefits of NLG919 to patients."

Genentech will be responsible for funding future research, development, manufacturing and commercialization, and will provide research funding for NewLink in conjunction with the research collaboration. For its part, NewLink will continue pursuing development activities for NLG919 in combination with its novel HyperAcute vaccine platform. NewLink will have an option for co-promotion rights for the compound and potential next-generation IDO/TDO compounds in the United States. The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Act.

"We are intrigued by the biology of the IDO and TDO compounds and are very interested in the potential to combine them with Genentech's portfolio of novel therapies," James Sabry, senior vice president and global head of Genentech Partnering, commented in a statement. "We are delighted to have initiated this significant partnership with NewLink. We hope this collaboration will lead to new therapies for people with cancer."

IDO pathway inhibitors are a class of immune checkpoint inhibitors, one of the newer areas of interest in cancer research. The IDO pathway is responsible for regulating immune response by suppressing T cell activation which allows for local tumor immune escape. Research has shown the IDO pathway to be active in several cancers, both within tumors as a defense against T cell attack and in antigen-presenting cells in tumor-draining lymph nodes, which allows the pathway to promote peripheral tolerance to tumor-associated antigens. When cancers manipulate the IDO pathway, it facilitates survival, growth and metastasis of malignant cells expressing tumor-associated antigens that might otherwise have been targeted by the immune system.

SOURCE: NewLink press release