NKTR-0165 / Nektar Therapeutics, Biolojic Design - LARVOL DELTA

Upcoming Milestones (PRNewswire) - "Preclinical data presentation from the NKTR-0165 (TNFR2 agonist antibody) program to be presented at a scientific conference in second half of 2026."

Preclinical • Immunology

Nektar Therapeutics Announces Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a Tumor Necrosis Factor Receptor 2 (TNFR2) Antibody, in Multiple Sclerosis (PRNewswire) - "The collaboration with UCSF will explore the potential role of TNFR2 agonism in the reduction of neurodegeneration and promotion of neuroprotection and cell repair when neurons are exposed to patient-derived B cells. Led by Dr. Hauser and his postdoctoral researcher Dr. Chaitrali Saha, the team at UCSF will conduct and fund all research efforts. Nektar will supply NKTR-0165 and will retain all rights to its programs under the collaboration."

Licensing / partnership • Multiple Sclerosis

Summary of Financial Results (PRNewswire) - "R&D expense in the third quarter of 2025 was $27.3 million as compared to $35.0 million for the third quarter of 2024....R&D expense decreased in the first nine months of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expenses for the development of rezpegaldesleukin and NKTR-0165."

Commercial • Atopic Dermatitis • Immunology • Oncology

Nektar Therapeutics Reports Second Quarter 2025 Financial Results (PRNewswire) - "...'We are proceeding in our IND-enabling studies for our next T reg program, NKTR-0165, which targets the TNFR2 receptor to stimulate tissue-specific T regulatory cells....Our goal is to advance NKTR-0165 into the clinic in 2026. Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target'."

New trial • Preclinical • Immunology

Nektar therapeutics outlines REZOLVE-AD phase 2b data and financial position for Q2 2025 (MSN News) - "Robin announced that top-line data from the 16-week induction period of the REZOLVE-AD Phase 2b study will be shared in June 2025, with the 36-week maintenance period results expected in early 2026...The REZOLVE-AD study aims to establish the efficacy and safety of REZPEG in biologic-naïve patients with moderate-to-severe atopic dermatitis. The Phase 2b study is focused on identifying a dose regimen for Phase 3 trials. Upcoming milestones include top-line data for the alopecia areata Phase 2b study in December 2025 and the initiation of a trial for type 1 diabetes later in the year, funded by TrialNet. The company plans to submit an IND for the TNFR2 agonist antibody program NKTR-0165 by the end of 2025."

IND • New trial • P2b data • Alopecia • Atopic Dermatitis • Diabetes

Nektar Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results (PRNewswire) - "...'With enrollment now complete for the atopic dermatitis...Phase 2b trial, we are on track to report topline data for rezpegaldesleukin in the second quarter...of this year'....'We plan to submit the IND for NKTR-0165 in the second half of this year'."

IND • P2b data • Atopic Dermatitis • Immunology • Inflammation

A NOVEL THERAPEUTICALLY ACTIVE ANTI-TNFR2 AGONISTIC ANTIBODY PROMOTES TREG PROLIFERATION AND INDUCTION OF TREG FUNCTIONAL MARKERS (EULAR 2024) - "Generation of a reliable and well-engineered TNFR2 agonist antibody can open new avenues in therapeutic intervention for autoimmune diseases... We have designed unique scFv-based TNFR2 binders recognizing a "signaling epitope". The lead antibody has Treg-selective agonistic biological activities, which is a desirable property in therapeutic intervention for various autoimmune diseases."

IO biomarker • Dermatitis • Immunology • Oncology • CD4 • CD8 • FOXP3 • TIGIT

Nektar Therapeutics Presents First Preclinical Data on NKTR-0165, a TNFR2 Agonist Antibody Being Developed for the Treatment of Inflammatory Diseases, at EULAR 2024 (PRNewswire) - "Nektar Therapeutics...announced the presentation of a poster highlighting new preclinical data on NKTR-0165 at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress....NKTR-0165 shows selective TNFR2 binding and receptor agonism in human Tregs, with minimal binding and signaling activity in other TNFR2-expressing immune cells in vitro and in vivo. NKTR-0165 agonistic activity enhances Treg lineage stabilization and upregulates expression of proteins involved in Treg proliferation and function. NKTR-0165 demonstrates therapeutic efficacy in a KLH-induced delayed type hypersensitivity (DTH) model in human TNFR2 knock-in mice."

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • Vitiligo

Biolojic Design Announces that Nektar Therapeutics Has Exercised Its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases (GlobeNewswire) - "Biolojic Design...announced that Nektar exercised its license option to develop a program resulting from the companies’ research collaboration initiated in 2021. The research collaboration was established to design and test agonistic antibodies targeting tumor necrosis factor receptor type II (TNFR2), a novel, biologically-validated disease target implicated in a wide range of autoimmune diseases that has been difficult to drug with conventional medicines....If the NKTR-0165 candidate proceeds through clinical development, Biolojic Design is entitled to development milestones and sales royalties....'We’re excited to be advancing NKTR-0165 through IND-enabling studies in 2024, with the goal of filing an IND in the first half of 2025.'"

IND • Licensing / partnership • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis