About Nektar Therapeutics

Nektar Therapeutics is a clinical stage, research-based drug discovery biopharmaceutical company. The company focuses on discovering and developing innovative medicines in the field of immunotherapy. 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, the company’s 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 focused on activating the immune system’s natural tumor-fighting mechanisms. Autoimmune diseases (rezpegaldesleukin) The company recognizes that many autoimmune diseases are caused by an imbalance in the body’s immune system. Rezpegaldesleukin has advanced to Phase 2 development, which the company’s collaboration partner, Lilly, has carried out in various indications. In February 2023, the company announced the topline data from the Phase 2 study of rezpegaldesleukin in adult patients with systemic lupus erythematosus (SLE) (Phase 2 Lupus Study). Lilly has also completed a Phase 1b study in patients with atopic dermatitis. The company and Lilly are working together to determine next steps for the planned Phase 2b study in atopic dermatitis, as well as a potential third Phase 2 study in a yet-to-be-announced autoimmune indication. 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 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’s development strategy for NKTR-255 is focused on three therapeutic areas: to enhance response to antibody-dependent cellular cytotoxicity (ADCC) mediated therapies by restoring NK cells, to improve CAR-T cell persistency in cellular therapies and to augment response to checkpoint inhibitors. The company is studying NKTR-255 in ADCC combinations in both liquid and solid tumors. It has initiated a Phase 1 dose escalation and expansion study of NKTR-255 in patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma where patients are treated with NKTR-255 as a monotherapy or NKTR-255 in combination with daratumumab. The company has also initiated a Phase 1/2 study of NKTR-255 in patients with relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer where patients are treated with NKTR-255 in combination with cetuximab. The company expects to receive data from the expansion stage of both studies in the second half of 2023. It is evaluating NKTR-255 following treatment with CAR-T cell therapy and initiated a Nektar-sponsored Phase 2/3 study (in the Phase 2 portion) to evaluate NKTR-255 following Yescarta or Breyanzi CD19 CAR-T cell therapy in patients with large B-cell lymphoma. The company expects initial data from the study to be available in the second half of 2024. Two ongoing investigator sponsored trials are also studying NKTR-255 in combination with CAR-T cell therapy. These studies include a Phase 1 study evaluating NKTR-255 in combination with CD19 CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphoma and a Phase 1 study evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. A third investigator sponsored study is evaluating NKTR-255 in combination with darvulumab in patients with unresectable Stage 3 non-small cell lung cancer who have received chemoradiation. The company is continuing its oncology clinical collaboration with Merck KGaA and Pfizer Inc. 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. It expects to receive topline data from the study in the second half of 2024. Other Research and Development Programs and Advanced Polymer Conjugate Technology Platform The company’s discovery research organization is continuing to identify new drug candidates by applying its technology platform to a wide range of molecule classes, including small molecules and proteins, peptides and antibodies. One of the company’s research programs is focused on developing a tumor necrosis factor (TNF) receptor 2 (TNFR2) agonist antibody. TNFR2 signaling drives immunoregulatory function and can provide a direct protective effect for tissue cells. Its focus is on TNFR2 antibody candidates that show selective Treg cell binding and signaling profiles that may be developed for the treatment of autoimmune diseases. In connection with this program, it is targeting IND readiness for a lead TNFR2 agonist antibody candidate by the end of 2023 in order to submit an Investigational New Drug (IND) filing for the first clinical study in 2024. The company also plans to continue its preclinical stage NKTR-288 development program. NKTR-288 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. The company’s advanced and proven polymer conjugate technology platform is focused on conjugating polyethylene glycol to a pharmaceutically active agent, a process often referred to as ‘PEGylation’. PEGylation has been a highly effective technology platform for the development of therapeutics with significant commercial success, such as Amgen’s Neulasta (pegfilgrastim) and UCB’s CIMZIA (certolizumab pegol). In addition to inventing new PEGylated drug candidates, the company’s expertise extends to developing robust manufacturing processes for generating the PEGylation reagents that allow it to utilize the full potential of this important technology. Patents and Proprietary Rights The company owns more than 300 U.S. and 1,500 foreign patents and a number of pending patent applications that cover various aspects of its technologies. Customer Concentrations The company derives the substantial majority of its PEGylation reagent product sales from UCB Pharma and Pfizer Inc. The company’s collaboration with Lilly for the development of rezpegaldesleukin provides for the most significant portion of its potential future development and regulatory milestone payments, as well as royalties from net sales of rezpegaldesleukin, if approved. 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. Government Regulation Product Development and Approval Process 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 FDA and by comparable regulatory agencies in other countries. Environment As a manufacturer of PEG reagents for the U.S. market, the company is subject to inspections 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. Competition In the fields of advanced polymer conjugate technologies, the company’s competitors include Biogen Idec Inc.; Horizon Pharma; Dr. Reddy’s Laboratories, Ltd.; Mountain View Pharmaceuticals, Inc.; SunBio Corporation; NOF Corporation; and Novo Nordisk A/S. History The company was founded in 1990. Nektar Therapeutics was incorporated in California in 1990 and reincorporated in Delaware in 1998.