| 2 min read
Register for free to listen to this article
Listen with Speechify
0:00
2:00
INDIANAPOLIS & SAN FRANCISCO—In the hopes of advancing a new option for treating several autoimmune and chronic inflammatory conditions, Eli Lilly and Co. and Nektar Therapeutics have inked a strategic collaboration for the co-development of NKTR-358, a novel immunological therapy and potential first-in-class resolution therapeutic.
 
Per the terms of the agreement, Lilly will pay Nektar $150 million in an initial payment, with the potential for up to $250 million in additional development and regulatory milestones. Nektar will assume responsibility for completing Phase 1 clinical development while the partners split Phase 2 development costs, with Lilly fielding 75 percent and Nektar 25 percent. Nektar will have the option to participate in Phase 3 development of the compound on an indication-by-indication basis, and also stands to receive double-digit royalties commensurate with their Phase 3 involvement as well as product sales. Lilly will handle global commercialization costs, and Nektar will have the option to co-promote the product in the United States under certain conditions. The deal is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions.
 
"We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market," Howard W. Robin, president and CEO of Nektar, said in a press release. "Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic."
 
It's thought that NKTR-358 could address one of the base immune system imbalances at the root of many autoimmune conditions as it targets the interleukin (IL-2) receptor complex to stimulate proliferation of regulatory T cells. This activation could rebalance the immune system and provide clinical impact and improved organ function. NKTR-358 achieved its first human dose in Phase 1 clinical development this March. The drug candidate is being developed as a once- or twice-monthly self-administered injection for a variety of autoimmune disorders, and at present is being evaluated in a Phase 1 dose-finding trial to establish a range of dose levels that could be advanced in additional clinical trials. The study will assess pharmacokinetics, safety and observed changes and functional activity of regulatory T cells in roughly 50 healthy subjects.
 
"We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions," said Dr. Thomas F. Bumol, senior vice president of Biotechnology and Immunology Research at Lilly. "NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly's commitment to sustain a flow of innovative medicines in our pipeline."
 
News of the deal came two weeks after Nektar announced positive preclinical results for NKTR-358 that demonstrated that treatment with the compound “induces profound regulatory T cell effects and suppresses inflammation in multiple preclinical models,” as noted in a press release. The results were shared at the 13th Annual World Congress on Inflammation earlier this month.
 
"These studies show that NKTR-358 increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases," Dr. Jonathan Zalevsky, senior vice president, Biology and Preclinical Development at Nektar, said in a press release at the time. "NKTR-358 also demonstrated suppression of antigen-driven inflammation in multiple preclinical models including systemic lupus erythematosus. We are very excited about NKTR-358's potential as a resolution therapy in autoimmune disease."

 
SOURCE: Nektar press release

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Gold circles with attached purple corkscrew shapes represent gold nanoparticles against a black background.

Driving gene therapy with nonviral vectors 

Learn why nonviral vectors are on the rise in gene therapy development.
A 3D digital illustration of a viral spike protein on a cell surface, surrounded by colorful, floating antibodies in the background

Milestone: Leapfrogging to quantitative, high throughput protein detection and analysis

Researchers continuously push the boundaries of what’s possible with protein analysis tools.
Blue cancer cells attached to a cellular surface against a bright blue background in a 3D rendering of a cancer infection.

Advancing immuno-oncology research with cellular assays

Explore critical insights into immunogenicity and immunotoxicity assays for cancer therapies.
Drug Discovery News November 2024 Issue
Latest IssueVolume 20 • Issue 6 • November 2024

November 2024

November 2024 Issue

Explore this issue