- Nektar Therapeutics said Monday it will collaborate with Eli Lilly on the development of an early-stage immmunological candidate, securing $150 million upfront from the pharma for a compound the San Francisco-based biotech discovered just 14 months ago.
- Known as NKTR-358, the drug is currently being tested in a small Phase 1 dose-finding study of healthy subjects. Nektar plans to initiate a Phase 1b study in lupus patients later this year and believes NKTR-358 may also be effective in treating autoimmune diseases or other inflammatory conditions such as rheumatoid arthritis.
- Per the deal, Nektar could receive another $250 million from Lilly if certain development and regulatory milestones are hit. Shares in Nektar, which was buoyed in March by positive Phase 3 results for its opioid painkiller candidate, rose by as much as 7% Monday morning before paring back gains.
Nektar has been riding high on positive momentum from its pipeline so far this year — developments that will be crucial for the biotech to grow beyond its current portfolio of partnered products.
Back in March, Nektar shares surged on the Phase 3 win from its opioid painkiller NKTR-181, data which could support an early filing with the Food and Drug Administration if all goes well.
Results reported last week from a human abuse potential study showed the analgesic had lower likeability across all doses compared to oxycodone in the time period immediately following administration. The data appears to support Nektar's claim NKTR-181 has a lower abuse potential due to its low permeability across the blood-brain barrier.
Nektar hopes to secure a collaboration on the painkiller by the end of this year to help move it through any additional studies that the FDA may require for submission.
Elsewhere in its pipeline, the biotech's lead immuno-oncology compound has attracted attention from big pharmas like Bristol-Myers Squibb and Takeda. NKTR-214 is designed to boost proliferation of cancer-killing T cells and natural killer cells by targeting a signaling receptor known as CD122 (a subunit of the IL-2 receptor). The Japanese drugmaker inked a research collaboration with Nektar in May to pair NKTR-214 with five cancer compounds in its pipeline, noting the candidate's potential to stimulate T-cells in the tumor micro-environment.
Nektar has retained global commercial rights to the drug, although Bristol-Myer Squibb retains the right of first negotiation on any licensing efforts through September 2018.
Similar to NKTR-214, NKTR-358 also targets the IL-2 pathway to influence cell populations in the body. In cancer, increasing binding to the receptor helps to reduce immune suppression and up production of T cells that will seek out and destroy cancer cells. NKTR-358 works in an opposite manner, essentially increasing immune suppression to counteract autoimmune or inflammatory conditions.
"We learned much about the IL-2 pathway and what was possible with our chemistry when we began work on [NKTR-] 214," said Jonathan Zalevsky, Nektar senior vice president of biology and preclinical development, in an email.
"This started us on a totally different research initiative where we discovered additional traits of the IL-2 pathway and IL2 biology and the possible medical applications in immunology."
Data from the Phase 1 study of NKTR-358 in healthy subjects is expected in the third quarter and the early study in lupus patients is slated to begin soon after that.
Lilly and Nektar will co-develop the candidate, splitting Phase 2 development costs 75%/25%, respectively. Nektar has an option to participate in Phase 3 development on an indication-by-indication basis, determining the level of royalties received on any future product sales.
For Lilly, the deal is a significant financial bet on a compound just out of the gate in clinical testing — an indication of the pharma's focus on continuing to build its pipeline in immunology.
Editor's note: This article has been updated to include comment from Nektar Therapeutics' senior vice president Jonathan Zalevsky that was emailed to BioPharma Dive after publication.