Nektar Therapeutics (Nektar) operates as a clinical stage, research-based drug discovery biopharmaceutical company focuses on discovering and developing innovative medicines in the field of immunotherapy.
Within this growing field, the company directs its efforts toward creating new immunomodulatory agents that selectively induce, amplify, attenuate, or prevent immune responses in order to achieve desired therapeutic outcomes. The company applies its deep understanding of immunology to identify...
Nektar Therapeutics (Nektar) operates as a clinical stage, research-based drug discovery biopharmaceutical company focuses on discovering and developing innovative medicines in the field of immunotherapy.
Within this growing field, the company directs its efforts toward creating new immunomodulatory agents that selectively induce, amplify, attenuate, or prevent immune responses in order to achieve desired therapeutic outcomes. The company applies its deep understanding of immunology to identify and create innovative drug candidates, and uses its drug development expertise to advance these molecules through preclinical and clinical development. The company’s pipeline of clinical-stage and preclinical-stage immunomodulatory agents targets the treatment of autoimmune diseases (e.g., rezpegaldesleukin and NKTR-0165, respectively) and cancer (e.g., NKTR-255).
Drug Candidates and Pipeline
By modulating the immune system, the company’s drug candidates target pathways that play critical roles in a wide range of serious diseases. In autoimmune diseases, its focus is on addressing imbalances in the immune system to restore the body’s self-tolerance mechanisms, and to achieve immune homeostasis. In oncology, the company focuses on activating the immune system’s natural tumor-fighting mechanisms.
Autoimmune Diseases
The company recognizes that many autoimmune diseases are caused by an imbalance in the body’s immune system.
Rezpegaldesleukin
The company’s drug candidate, rezpegaldesleukin, is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with autoimmune disorders and inflammatory diseases. It is designed to target the interleukin-2 (IL-2) receptor complex in the body in order to stimulate the proliferation of Treg cells. By activating these cells, rezpegaldesleukin may act to bring the immune system back into balance. Rezpegaldesleukin is being developed as a once or twice monthly self-administered injection for a number of autoimmune disorders and inflammatory diseases.
On October 13, 2023, the company announced final efficacy data from a Phase 1b study of rezpegaldesleukin in adult patients with atopic dermatitis (Phase 1b AD Study) at the European Academy of Dermatology and Venereology conference. The final efficacy data from the Phase 1b AD study showed that patients with moderate-to-severe atopic dermatitis who were treated with rezpegaldesleukin had dose-dependent improvements in the eczema area and severity index (EASI), validated investigator global assessment (vIGA), body surface area (BSA), and itch numeric rating scale (NRS) over twelve weeks of treatment compared to placebo, which were sustained post-treatment over an additional thirty-six weeks. Rezpegaldesleukin was well tolerated, with no patients in the rezpegaldesleukin groups experiencing severe, serious, or fatal adverse events, and no anti-rezpegaldesleukin antibodies were detected.
In late October 2023, the company initiated a Phase 2b clinical study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis, which remains on track for a topline data readout in the first half of 2025. On February 11, 2025, the company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
In March 2024, the company initiated a Phase 2b clinical study of rezpegaldesleukin in patients with severe-to-very severe alopecia areata, which remains on track for a topline data readout in the second half of 2025.
The company plans to explore other autoimmune indications for the development of rezpegaldesleukin.
On February 24, 2025, the company announced that it had entered into a clinical trial agreement with TrialNet, an international clinical trial network focused on diabetes research, to evaluate rezpegaldesleukin in patients with new onset stage 3 type 1 diabetes mellitus (TID). Under the agreement, TrialNet will conduct and provide funding for a Phase 2 randomized, double-blind, placebo-controlled clinical trial to investigate the safety and potential efficacy of rezpegaldesleukin in approximately 70 adults and children with new onset stage 3 TID. The company will supply rezpegaldesleukin for the trial, and will provide support for the study, including pharmacokinetic and other analyses. The company will retain all rights to rezpegaldesleukin under the collaboration.
The company developed rezpegaldesleukin and owns full rights to this drug candidate. Although the company previously entered into a license agreement with Eli Lilly and Company in 2017 (the Lilly Agreement) to develop and commercialize rezpegaldesleukin, on April 23, 2023, it received from Lilly a notice of at-will termination of the Lilly Agreement, and on April 27, 2023, the company announced that it would be regaining full rights to rezpegaldesleukin.
NKTR-0165
TNFR2 signaling drives immunoregulatory function and can provide a direct protective effect for tissue cells. TNFR2 is highly expressed on Tregs, neuronal cells, and endothelial cells, and has been shown to potentiate the suppressive effects and overall functional properties of Tregs. The company’s focus is on TNFR2 antibody candidates that show selective Treg cell binding and signaling profiles that may be potentially developed for the treatment of autoimmune diseases, such as ulcerative colitis, multiple sclerosis, and vitiligo. The company is conducting Investigational New Drug (IND) enabling studies for this program, after having exercised an option to gain an exclusive license to specified agonistic antibodies and other materials that were developed pursuant to a research collaboration and license option agreement the company entered into with Biolojic Design, Ltd. in 2021, with the goal of preparing for an IND submission in the second half of 2025.
Oncology
NKTR-255
In oncology, the company focuses on developing medicines based on targeting biological pathways that stimulate and sustain the body’s immune response in order to fight cancer. NKTR-255 is an investigational biologic that is designed to target the interleukin-15 (IL-15) pathway in order to activate the body’s innate and adaptive immunity. Activation of the IL-15 pathway enhances the survival and function of natural killer (NK) cells, and induces the survival of both effector and CD8+ memory T cells. Recombinant human IL-15 is rapidly cleared from the body and must be administered frequently and in high doses, limiting its utility due to toxicity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and the formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.
The company is continuing select developmental studies of NKTR-255 in combination with cell therapies and checkpoint inhibitors while it evaluates additional strategic partnership pathways for the program. The company initiated a Nektar-sponsored Phase 2/3 study to evaluate NKTR-255 following Yescarta or Breyanzi CD19 CAR-T cell therapy in patients with large B-cell lymphoma, and announced results from the Phase 2 portion of the study at the 66th Annual American Association of Hematology (ASH) Meeting in December 2024. Fred Hutchinson Cancer Center is also evaluating NKTR-255 following Breyanzi CD19 CAR-T cell therapy in patients with relapsed/refractory large B-cell lymphoma in an investigator-sponsored study. The company is continuing its oncology clinical collaboration with Merck KGaA to evaluate the maintenance regimen of NKTR-255 in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma in the Phase II JAVELIN Bladder Medley study. The company expects to receive topline data from the study in the first half of 2025. The company entered into a new clinical study collaboration with AbelZeta Pharma, Inc. (AbelZeta) to study NKTR-255 in combination with its C-TIL051, a tumor-infiltrating lymphocyte (TIL) therapy, in advanced non-small cell lung cancer (NSCLC) patients that are relapsed or refractory to anti-PD-1 therapy. Under the collaboration, the company will contribute NKTR-255, and AbelZeta will add NKTR-255 to its ongoing AbelZeta-sponsored Phase 1 clinical trial. The company also has an ongoing investigator-sponsored study evaluating NKTR-255 in combination with IMFINZI (darvulumab) in patients with unresectable Stage 3 NSCLC who have received chemoradiation.
Other Research and Development Programs
The company’s discovery research organization continues to leverage its deep understanding of immunology to identify new drug candidates in a wide range of molecule classes, including proteins, peptides, and antibodies.
The company’s preclinical PEG-Colony Stimulating Factor (PEG-CSF1) program, NKTR-422, which is a polyethylene glycol modified version of the CSF1 protein that is intended to optimize receptor interaction and to selectively modulate resolution processes of inflammation, has applications in a number of therapeutic indications, including acute and chronic inflammation, as well as fibrosis. The company also maintains its preclinical oncology asset, NKTR-288, which is an investigational PEG conjugate of the protein interferon gamma that is designed utilizing a site-specific conjugation approach to modify binding of interferon gamma with one of its substrates, and to optimize the pharmacodynamic duration of interferon gamma signaling.
Many of the company’s drug candidates incorporate advanced and proven polymer conjugate technology, which involves conjugating polyethylene glycol to a pharmaceutically active agent, a process often referred to as ‘PEGylation.’ PEGylation has been a highly effective technology for the development of therapeutics with significant commercial success, such as Amgen’s Neulasta (pegfilgrastim), and UCB’s CIMZIA (certolizumab pegol).
The company previously owned a manufacturing facility in Huntsville, Alabama (the Facility), which manufactured the company’s proprietary polyethylene glycol reagents (PEG reagents) for its PEGylation and advanced polymer conjugate technology operations. In December 2024, the company sold the Facility and assigned its manufacturing and supply agreements to Gannet BioChem, an affiliate of Ampersand Management LLC d/b/a Ampersand Capital Partners.
Government Regulation
The research and development, clinical testing, manufacture, and marketing of the company’s drug candidates and products using its technologies are subject to regulation by the U.S. Food and Drug Administration (FDA) and by comparable regulatory agencies in other countries.
Patents and Proprietary Rights
The company owns more than 150 U.S. and 700 foreign patents, and a number of pending patent applications that cover various aspects of its research and development efforts.
Trademarks
The Nektar brand and product names, including but not limited to Nektar, contained in this document are trademarks and registered trademarks of Nektar Therapeutics in the United States (U.S.) and certain other countries.
Customer Concentrations
The company derived the substantial majority of its PEGylation reagent product sales from UCB and Pfizer. Following the 2020 Purchase and Sale Agreement (wherein under a capped return sale arrangement the company sold its rights to receive royalties on future worldwide new sales of MOVANTIK/MOVANTIG and ADYNOVATE/ADYNOVI, as well as REBINYN and specified licensed products), other than its product sales, substantially all of its revenues are non-cash royalty revenues.
Environment
As a manufacturer of proprietary polyethylene glycol reagents (PEG reagents) for clinical drug candidates and commercial drug products, the company is subject to inspections generally applicable to manufacturers of important components of pharmaceuticals, particularly inspections carried out by the FDA and the U.S. Environmental Protection Agency for compliance with current good manufacturing practices (cGMP) and other U.S. regulatory requirements, including the U.S. federal, state, and local regulations regarding environmental protection and hazardous and controlled substance controls, among others.
History
The company was founded in 1990. Nektar Therapeutics was incorporated in California in 1990 and reincorporated in Delaware in 1998.