This Phase 2 study is a 2-arm, multi-center, double-masked, placebo-controlled, 2:1 randomized sequential trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

开始日期2025-11-13

申办/合作机构

National Institute of Diabetes & Digestive & Kidney Diseases

NCT06340360

/ Active, not recruiting临床2期

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata.
The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.

开始日期2024-04-02

申办/合作机构

Nektar Therapeutics

NCT06136741

/ Active, not recruiting临床2期

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.

开始日期2023-11-15

申办/合作机构

Nektar Therapeutics

100 项与 Rezpegaldesleukin 相关的临床结果

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100 项与 Rezpegaldesleukin 相关的转化医学

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100 项与 Rezpegaldesleukin 相关的专利（医药）

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项与 Rezpegaldesleukin 相关的文献（医药）

2025-04-18·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Biological activity and antitumor effect of long-acting recombinant human interleukin-2 drug].

Article

作者: Zhang, Fengxia ; Zhu, Jingjing ; Jin, Ting ; Liang, Xuejun

OBJECTIVE:

To investigate the biological activity and antitumor effect of pegylated recombinant human interleukin 2 (PEG-rhIL-2) obtained by site-specific conjugation of polyethylene glycol (PEG) with non-natural amino acids, and to explore its antitumor mechanism.

METHODS:

The binding activities of PEG-rhIL-2 at three different sites (T41, Y45, and V91) to human interleukin 2 receptors α (IL-2R_α) and β (IL-2R_β) and were detected by surface plasmon resonance (SPR) technology. Western blot was used to detect the levels of the Janus kinase-signal transducer and activator of transcription 5 (JAK-STAT5) signaling pathway activated by different doses of rhIL-2 and PEG-rhIL-2 in CTTL-2 and YT cells. Blood was collected after a single administration in mice to detect the drug concentration at different time points and evaluate the pharmacokinetic parameters of Y45-PEG-rhIL-2. Mouse hepatoma cell line Hepa1-6, pancreatic cancer cell line Pan-02, and colon cancer cell line MC-38 were selected. Tumor models were constructed in C57BL/6 mice. Different doses of Y45-PEG-rhIL-2 and excipient control were administrated respectively to evaluate the tumor suppression effect of the drug. In the MC-38 colon cancer model, the tumor suppression effect of Y45-PEG-rhIL-2 combined with anti-programmed death-1 (PD-1) monoclonal antibody was evaluated. Hepa1-6 mouse tumor models were constructed and rhIL-2, Y45-rhIL-2 and Y45-PEG-rhIL-2 were administrated respectively. The proportion of tumor-infiltrating lymphocytes was analyzed by flow cytometry.

RESULTS:

The SPR detection results showed that the binding activities of PEG-rhIL-2 to IL-2R_α/IL-2R_β were both reduced. The affinity of Y45-PEG-rhIL-2 to IL-2R_α was reduced to approximately 1/250, and its affinity to IL-2R_β was reduced to 1/3. Western blot results showed that the activity of Y45-PEG-rhIL-2 in stimulating JAK-STAT5 signaling in CTLL-2 cells expressing heterotrimeric IL-2 receptor complex IL-2R_αβγwas reduced to approximately 1/300, while its activity in YT cells expressing heterodimeric IL-2 receptor complex IL-2R_βγwas reduced to approximately 1/3. The pharmacokinetic evaluation after a single dose in the mice showed that the elimination half-life of Y45-PEG-rhIL-2 was 17.7 h. Y45-PEG-rhIL-2 has pharmacokinetic characteristics superior to those of rhIL-2. Y45-PEG-rhIL-2 showed dose-dependent tumor suppression activity, and the combination of Y45-PEG-rhIL-2 and anti-PD-1 antibody had a better tumor-inhibiting effect than the single use of Y45-PEG-rhIL-2 or anti-PD-1 antibody. Flow cytometry analysis demonstrated that 72 h after the administration of Y45-PEG-rhIL-2, the proportion of tumor-infiltrating cytotoxic T lymphocytes (CD8⁺T cells) increased by 86.84%. At 120 h after administration, the ratio of CD8⁺T cells to regulatory T cells (Treg) increased by 75.10%.

CONCLUSION:

Y45-PEG-rhIL-2 obtained by site-specific conjugation via non-natural amino acids changed its receptor binding activity and inhibited tumor growth in dose-dependent manner in multiple tumor models by regulating CD8⁺T cells.

2022-01-01·Journal of translational autoimmunity

Selective expansion of regulatory T cells by NKTR-358 in healthy volunteers and patients with systemic lupus erythematosus

Article

作者: Furie, Richard ; Levin, Robert ; Diab, Isam ; Fanton, Christie ; Chindalore, Vishala ; Hanan, Nathan ; Zalevsky, Jonathan ; Dickerson, Daniel ; Dixit, Neha ; Haglund, Cat ; Kotzin, Brian L ; Gibbons, Jacqueline

Objective:

To evaluate NKTR-358, a polyethylene glycol-interleukin-2 conjugate composition designed to selectively induce regulatory T cells (Tregs), in first-in-human studies.

Methods:

Healthy volunteers and patients with systemic lupus erythematosus (SLE) received single- or multiple-dose (biweekly) NKTR-358 or placebo in two sequential, randomized, phase 1 studies (single ascending dose [SAD; NCT04133116] and multiple ascending dose [MAD; NCT03556007]). Primary objectives were safety and tolerability; secondary objectives included pharmacokinetics (PK) and immune effects of NKTR-358; exploratory objectives included effects on SLE disease activity.

Results:

There were eight ascending dose cohorts in the SAD study (0.3-28.0 μg/kg: n = 76; placebo: n = 24) and four in the MAD study (3-24.0 μg/kg: n = 36; placebo: n = 12). Most adverse events (AEs) were grade 1-2 injection-site reactions, with no treatment-related serious or severe AEs, or deaths. PK data showed dose proportionality and prolonged exposure (mean half-life: 7.4-12.9 days). Dose-dependent, selective, and sustained increases in percentages and absolute numbers of total CD4⁺ Tregs and CD25^bright Tregs were observed, with no significant changes in conventional CD4⁺ and CD8⁺ T cells, and low-level increases in natural killer cells. At the highest doses tested, administration of NKTR-358 resulted in a 12-17-fold increase in CD25^bright Tregs over baseline that was sustained for 20-30 days.

Conclusion:

NKTR-358 was well tolerated, had a suitable PK profile for biweekly dosing, and led to marked and selective dose-dependent increases in CD25^bright Tregs, with no significant changes in conventional T cells. These results provide strong support for further testing in SLE and other inflammatory diseases.

2021-01-01·Journal of translational autoimmunity

NKTR-358: A novel regulatory T-cell stimulator that selectively stimulates expansion and suppressive function of regulatory T cells for the treatment of autoimmune and inflammatory diseases

Article

作者: Zhang, Ping ; Lee, Myong ; Kuo, Peiwen ; Dixit, Neha ; Doberstein, Stephen K ; Fanton, Christie ; Cetz, Janet ; Sweeney, Theresa D ; Kamihara, Yusuke ; VanderVeen, Laurie A ; Dixit, Vidula ; Chang, Thomas ; Rubas, Werner ; Langowski, John L ; Kirksey, Yolanda ; Ritz, Jerome ; Tang, Yinyan ; Zalevsky, Jonathan ; Maiti, Mekhala ; Ji, Chunmei ; Kim, Grace ; Kirk, Peter

Impaired interleukin-2 (IL-2) production and regulatory T-cell dysfunction have been implicated as immunological mechanisms central to the pathogenesis of multiple autoimmune and inflammatory diseases. NKTR-358, a novel regulatory T-cell stimulator, is an investigational therapeutic that selectively restores regulatory T-cell homeostasis in these diseases. We investigated NKTR-358's selectivity for regulatory T-cells, receptor-binding properties, ex vivo and in vivo pharmacodynamics, ability to suppress conventional T-cell proliferation in mice and non-human primates, and functional activity in a murine model of systemic lupus erythematosus. In vitro, NKTR-358 demonstrated decreased affinity for IL-2Rα, IL-2Rβ, and IL-2Rαβ compared with recombinant human IL-2 (rhIL-2). A single dose of NKTR-358 in cynomolgus monkeys produced a greater than 15-fold increase in regulatory T-cells, and the increase lasted until day 14, while daily rhIL-2 administration for 5 days only elicited a 3-fold increase, which lasted until day 7. Repeated dosing of NKTR-358 over 6 months in cynomolgus monkeys elicited cyclical, robust increases in regulatory T-cells with no loss in drug activity over the course of treatment. Regulatory T-cells isolated from NKTR-358-treated mice displayed a sustained, higher suppression of conventional T-cell proliferation than regulatory T-cells isolated from vehicle-treated mice. NKTR-358 treatment in a mouse model (MRL/MpJ-Fas^lpr) of systemic lupus erythematosus for 12 weeks maintained elevated regulatory T-cells for the treatment duration and ameliorated disease progression. Together, these results suggest that NKTR-358 has the ability to elicit sustained and preferential proliferation and activation of regulatory T-cells without corresponding effects on conventional T-cells, with improved pharmacokinetics compared with rhIL-2.

123

项与 Rezpegaldesleukin 相关的新闻（医药）

2025-08-14

·PRNewswire

Cancer Treatment Stocks Surge as $866B Market Attracts Private Investment

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- USA News Group News Commentary – Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Fate Therapeutics, Inc. (NASDAQ: FATE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), and Nektar Therapeutics (NASDAQ: NKTR). Global Market Insights estimates the global oncology market at US$345.1 billion in 2025 and forecasts it will climb to US$866.1 billion by 2034, growing at a robust 10.8% CAGR. The U.S. alone is expected to contribute $377.1 billion to that total. Vision Research Reports projects an even larger figure for the global cancer drug sector, predicting it will surpass US$900 billion in sales by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep. In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025. For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone. Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution. Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners. The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population. Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment. With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC. The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported strong Q2 2025 results with $60 million in total product revenue, driven primarily by its breakthrough melanoma therapy Amtagvi, which treated over 100 patients in the second quarter. "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs." The company's tumor-infiltrating lymphocyte (TIL) therapy—which uses a patient's own immune cells to fight cancer—generated $54.1 million in revenue and represents the first FDA-approved T-cell therapy for solid tumors, offering new hope for advanced melanoma patients who have tried other treatments without success. With expanded clinical trials planned for lung cancer and endometrial cancer, plus international approvals expected in Canada and other markets, Iovance is positioned to bring its innovative cancer treatment to patients worldwide. Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced promising clinical progress for its off-the-shelf CAR T-cell therapy FT819, which showed lasting responses in lupus patients and received FDA clearance to begin trials for a solid tumor program targeting MICA/B proteins. While primarily focused on autoimmune diseases, the company's next-generation FT836 CAR T-cell therapy represents a significant advancement in cancer treatment as it's designed to target solid tumors without requiring harsh conditioning chemotherapy, potentially making the treatment safer and more accessible. "Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield™ technology toward the clinic." The company's stem cell-based platform continues to advance multiple programs, including partnerships for HER2-positive solid tumors, positioning Fate as a leader in developing ready-made cancer cell therapies. Inovio Pharmaceuticals, Inc. (NASDAQ: INO) remains on track to submit its application for INO-3107 in the second half of 2025, targeting Recurrent Respiratory Papillomatosis (RRP), a rare cancer-related condition caused by HPV that affects the airways. The company's DNA medicine platform represents a novel approach to treating HPV-related diseases and cancers, with INO-3107 showing significant clinical benefit by reducing the need for repeated surgeries in RRP patients from an average of 4.1 procedures annually to just 0.9 procedures. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease," said Dr. Jacqueline Shea, President and CEO of INOVIO. "I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026." Beyond RRP, Inovio's technology platform is designed to treat various HPV-related cancers and other tumors by teaching the body's immune system to recognize and fight cancer cells. With breakthrough therapy designation from the FDA and plans for a trial involving 100 patients, INO-3107 could become the first DNA-based therapy approved for treating this serious cancer-related condition. Nektar Therapeutics (NASDAQ: NKTR) reported impressive Phase 2b data for rezpegaldesleukin in treating moderate to severe atopic dermatitis, with the company positioning this immune system regulator as a first-in-class treatment for autoimmune diseases. While primarily focused on autoimmune conditions, Nektar's pipeline includes NKTR-255, a treatment designed to boost the immune system's ability to fight cancer, which is being tested in multiple ongoing clinical trials with various partners. "As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders," said Howard W. Robin, President and CEO of Nektar. "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." The company's technology platform creates novel treatments that could potentially address both autoimmune diseases and cancer by enhancing the immune system's cancer-fighting abilities. With additional data expected from hair loss trials in December 2025 and continued development of next-generation programs, Nektar is advancing a unique approach to immune system therapy that could benefit millions of patients with serious diseases. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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免疫疗法临床2期孤儿药临床结果

2025-08-07

·PRNewswire

Nektar Therapeutics Reports Second Quarter 2025 Financial Results

SAN FRANCISCO, Aug. 7, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the second quarter ended June 30, 2025. Cash and investments in marketable securities on June 30, 2025 were $175.9 million as compared to $269.1 million on December 31, 2024. Nektar's cash and marketable securities at June 30, 2025 do not include $107.5 million of approximate net proceeds from the secondary offering closed on July 2, 2025. With the net proceeds from the secondary offering, we expect our cash and investments in marketable securities to support our operations into the first quarter of 2027. "This quarter, we announced transformative data for rezpegaldesleukin from the Phase 2b study in patients with moderate to severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "The 16-week induction data demonstrated that rezpegaldesleukin resulted in a rapid onset of EASI response and itch relief and showcased the advantage of a broad-based Treg mechanism over other mechanistic approaches in development to treat atopic dermatitis. We look forward to seeing the effect of continued treatment with rezpegaldesleukin when we report the 52-week data in early 2026. In alopecia areata, we will report the data from a separate Phase 2b study in December of this year. We believe the data from both randomized studies will demonstrate the potential of rezpegaldesleukin to provide a new treatment paradigm for patients with chronic and serious diseases that significantly impact quality of life. As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders." "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," continued Robin. "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." Summary of Financial Results Revenue in the second quarter of 2025 was $11.2 million as compared to $23.5 million in the second quarter of 2024. Revenue for the first half of 2025 was $21.6 million as compared to $45.1 million in the first half of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024. Total operating costs and expenses in the second quarter of 2025 were $47.4 million as compared to $73.3 million in the second quarter of 2024. Total operating costs and expenses in the first half of 2025 were $102.4 million as compared to $130.3 million in the first half of 2024. Operating costs and expenses for the first half of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility, as well as a decrease in restructuring and impairment charges. R&D expense in the second quarter of 2025 was $29.9 million as compared to $29.7 million for the second quarter of 2024. R&D expense in the first half of 2025 was $60.4 million as compared to $57.1 million for the first half of 2024. R&D expense increased for the first half of 2025 primarily due to an increase in expenses for the development of rezpegaldesleukin and NKTR-0165, partially offset by a decrease in expense for the development of NKTR-255. G&A expense was $17.1 million in the second quarter of 2025 as compared to $20.5 million in the second quarter of 2024. G&A expense was $41.4 million in the first half of 2025 as compared to $40.7 million in the first half of 2024. G&A expense increased slightly in the first half of 2025 due to an increase in legal expenses, partially offset by decreases in facilities and stock-based compensation expenses. Non-cash restructuring and impairment charges were not material in the second quarter and first half of 2025. Non-cash restructuring and impairment charges in the second quarter of 2024 were $13.3 million and $14.3 million in the first half of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar. In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem's equity each quarter. This resulted in non-cash losses from the equity method investment of $2.4 million in the second quarter of 2025 and $6.8 million in the first half of 2025. Net loss for the second quarter of 2025 was $41.6 million or $2.95 basic and diluted loss per share as compared to a net loss of $52.4 million or $3.761 basic and diluted loss per share in the second quarter of 2024. Net loss in the first half of 2025 was $92.5 million or $6.57 basic and diluted loss per share as compared to a net loss of $89.2 million or $6.631 basic and diluted loss per share in the first half of 2024. Excluding the $2.4 million and $6.8 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the second quarter and first half of 2025 were $39.2 million and $85.6 million, respectively, or $2.78 and $6.08 basic and diluted loss per share, respectively. Recent Business Highlights In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters' option to purchase additional shares, raising $115 million in gross proceeds. In June of 2025, Nektar announced that the REZOLVE-AD study achieved statistical significance on the primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo and achieved statistical significance for key secondary endpoints at week 16, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA. The rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory T-cell mechanism as a first and best-in-class immune-modulator. In June of 2025, Nektar collaborators at the Fred Hutchinson Cancer Center presented oral data for NKTR-255 as adjunctive treatment to cell therapy at the 30th Annual European Hematological Association (EHA) Congress entitled, "Enhanced CAR T-cell Expansion and Durable Complete Responses with NKTR-255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B-cell Lymphoma." Conference Call to Discuss Second Quarter 2025 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on August 7, 2025. This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: . The web broadcast of the conference call will be available for replay through September 8, 2025. To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Nektar's pipeline also includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody and bispecific programs, NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow Nektar on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "expect," "develop," "potential," "advance," "plan," "target," "believe," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for, rezpegaldesleukin, NKTR-0165, NKTR-0166, NKTR-422, and NKTR-255. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-0165, NKTR-0166, NKTR-422 and NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-0165, NKTR-0166, NKTR-422 and NKTR-255 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-0165, NKTR-0166, NKTR-422 and NKTR-255 are in clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) a Fast Track designation does not increase the likelihood that rezpegaldesleukin will receive marketing approval in the United States; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2025. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts: For Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC [email protected] 212-915-2577 Ahu Demir, Ph.D. LifeSci Advisors, LLC [email protected] 212-915-3820 For Media: Madelin Hawtin LifeSci Communications 603-714-2638 SOURCE Nektar Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期财报快速通道临床结果细胞疗法

2025-08-04

·PMLiVE

FDA grants fast track designation to Nektar’s rezpegaldesleukin in alopecia areata

The US Food and Drug Administration (FDA) has granted fast track designation to Nektar Therapeutics’ rezpegaldesleukin as a treatment for alopecia areata (AA). The regulator’s decision specifically applies to adult and paediatric patients aged 12 years and older who weigh at least 40 kilograms and are living with severe-to-very severe cases of the autoimmune disease. Approximately 700,000 people in the US currently have some form of AA, which occurs when a patient’s own immune system attacks hair follicles, resulting in varying degrees of hair loss. Rezpegaldesleukin, which has already been granted FDA fast track designation for moderate-to-severe atopic dermatitis, is designed to target the interleukin-2 receptor complex in the body, stimulating the proliferation of inhibitory immune cells called Tregs and potentially bringing the immune system back into balance. The phase 2b REZOLVE-AA trial is currently evaluating the drug in patients with severe-to-very severe AA who have at least 50% scalp involvement and have not previously been treated with a JAK inhibitor or other biologic. The primary efficacy endpoint of the study will evaluate the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period. Jonathan Zalevsky, senior vice president and chief research and development officer at Nektar, said: “AA is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches that could treat the underlying pathogenesis of this disorder. “We remain on track to announce top-line data in December from our ongoing REZOLVE-AA phase 2b study for rezpegaldesleukin in AA, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational programme following the completion of phase 2.” In line with the FDA’s fast track designation process, designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, Nektar will now be eligible for more frequent meetings and written interactions with the FDA to discuss rezpegaldesleukin’s development plan in AA. The drug may also be eligible for rolling review and priority review.

临床2期快速通道优先审批

100 项与 Rezpegaldesleukin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
斑秃	临床2期	美国	Nektar Therapeutics	2024-04-02
斑秃	临床2期	加拿大	Nektar Therapeutics	2024-04-02
斑秃	临床2期	波兰	Nektar Therapeutics	2024-04-02
中度特应性皮炎	临床2期	美国	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	澳大利亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	保加利亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	加拿大	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	克罗地亚	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	捷克	Nektar Therapeutics	2023-11-15
中度特应性皮炎	临床2期	德国	Nektar Therapeutics	2023-11-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06136741 (REZOLVE-AD, PRNewswire) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	393	Rezpegaldesleukin 24 µg/kg q2w	製夢醖選築衊鬱齋糧觸(衊襯鹽蓋觸築顧醖顧願) = 餘鏇壓製獵蓋壓鬱淵憲鏇蓋繭窪餘蓋鹽淵積淵 (遞窪繭顧遞醖範鏇憲憲 ) 达到更多	积极	2025-06-24
				Rezpegaldesleukin 18 µg/kg q2w	製夢醖選築衊鬱齋糧觸(衊襯鹽蓋觸築顧醖顧願) = 夢選壓憲齋衊憲簾鑰網鏇蓋繭窪餘蓋鹽淵積淵 (遞窪繭顧遞醖範鏇憲憲 ) 达到更多
Pubmed \| Nat Commun	临床1期	炎症性皮肤病 Eczema Area and Severity Index (EASI) \| Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) \| Psoriasis Area and Severity Index (PASI) ... 更多	-	Rezpegaldesleukin 10-12 µg/kg	選蓋淵顧構糧製醖獵憲(積築遞鬱構觸顧構憲觸) = EASI-75 responses are maintained for 36 weeks after treatment discontinuation in 71% of week 12 responders 選糧鬱獵壓鹽餘網鑰膚 (獵獵廠製網選鹹遞鹽蓋 ) 更多	积极	2024-10-25
NCT04433585 (ISLAND-SLE, CTgov)	临床2期	系统性红斑狼疮	291	LY3471851 (LY3471851 High Dose)	艱範範觸鏇簾憲淵醖醖 = 餘繭製網廠顧鹹壓選襯廠鹹製膚構鏇襯遞齋鬱 (網廠選餘廠鑰網膚選獵, 艱範憲構觸廠鏇窪艱襯 ~ 齋鏇糧醖築衊築齋製繭) 更多	-	2024-04-23
				LY3471851 (LY3471851 Mid Dose)	艱範範觸鏇簾憲淵醖醖 = 繭遞鬱鏇積糧選鏇淵襯廠鹹製膚構鏇襯遞齋鬱 (網廠選餘廠鑰網膚選獵, 願積糧製糧醖衊齋鏇鹹 ~ 鹽衊醖糧壓簾蓋艱鏇鬱) 更多
NCT04081350 (Phase 1b study, EADV2023)	临床1期	特应性皮炎 Treg	-	Rezpegaldesleukin 12 µg/kg	膚糧獵壓憲積積築顧壓(觸糧獵鏇襯繭窪壓衊範) = 築鬱壓鑰艱鹹衊餘遞築窪鹽鹽醖簾積網憲構襯 (餘窪膚鑰繭鑰膚鹽鑰選 ) 更多	积极	2023-10-11
				Rezpegaldesleukin 24 µg/kg	膚糧獵壓憲積積築顧壓(觸糧獵鏇襯繭窪壓衊範) = 遞襯獵夢蓋鑰選範鏇衊窪鹽鹽醖簾積網憲構襯 (餘窪膚鑰繭鑰膚鹽鑰選 ) 更多
NCT04677179 (INSTRUCT-UC, CTgov)	临床2期	溃疡性结肠炎	81	Placebo (Placebo (Induction Treatment Period))	醖獵襯膚獵夢鑰膚壓築 = 艱積衊繭築齋鏇艱憲蓋淵壓簾膚網淵遞齋網鏇 (鏇鬱範糧鹽範製憲顧齋, 鹹範築醖淵繭壓獵範醖 ~ 壓鹹遞艱齋夢糧蓋膚廠) 更多	-	2023-09-05
				LY3471851 (Low Dose LY3471851 (Induction Treatment Period))	醖獵襯膚獵夢鑰膚壓築 = 遞網積衊遞範艱觸鏇廠淵壓簾膚網淵遞齋網鏇 (鏇鬱範糧鹽範製憲顧齋, 窪鹽窪餘願窪艱窪窪網 ~ 糧範糧廠選艱鏇淵獵蓋) 更多
NCT04433585 (ISLAND-SLE, Corporate Publications) 人工标引	临床2期	系统性红斑狼疮	291	rezpegaldesleukin 300mcg Q2W	衊夢醖選鏇壓窪遞齋繭(餘積蓋簾蓋鏇襯淵鹽構) = 築願遞窪鹹鑰遞艱範壓襯簾顧糧鏇構廠鹽窪構 (網襯壓選憲鹹觸觸鹹鬱 ) 更多	不佳	2023-02-23
				rezpegaldesleukin 900mcg Q2W	衊夢醖選鏇壓窪遞齋繭(餘積蓋簾蓋鏇襯淵鹽構) = 襯壓夢網夢範夢積鏇繭襯簾顧糧鏇構廠鹽窪構 (網襯壓選憲鹹觸觸鹹鬱 ) 更多
NCT04119557 (Corporate Publications) 人工标引	临床1期	银屑病	26	LY3471851	憲簾齋觸衊淵範淵築齋(構積構範憲壓鑰衊齋獵) = 夢繭積鏇顧襯鏇壓鑰憲繭繭積鑰築鏇顧簾醖衊 (獵繭積餘簾衊鑰廠願鹽 ) 更多	积极	2022-09-07
				Placebo	憲簾齋觸衊淵範淵築齋(構積構範憲壓鑰衊齋獵) = 願獵繭鏇餘鏇範觸繭鏇繭繭積鑰築鏇顧簾醖衊 (獵繭積餘簾衊鑰廠願鹽 ) 更多
NCT04081350 (Corporate Publications) 人工标引	临床1期	特应性皮炎	43	LY3471851 12 µg/kg	齋遞糧糧醖繭艱醖網獵(鏇積鏇選鑰積鏇鏇築鏇) = 網鬱願遞願製鏇糧繭壓範膚壓膚艱壓窪積觸窪 (憲鹹廠鑰膚鹽簾壓簾衊 ) 更多	积极	2022-09-07
				LY3471851 24 µg/kg	齋遞糧糧醖繭艱醖網獵(鏇積鏇選鑰積鏇鏇築鏇) = 夢襯簾範廠製糧憲憲遞範膚壓膚艱壓窪積觸窪 (憲鹹廠鑰膚鹽簾壓簾衊 ) 更多
NCT03556007 (Corporate Publications) 人工标引	临床1期	系统性红斑狼疮	48	NKTR-358	簾膚遞齋鹹衊窪蓋範遞(淵鹹鑰襯獵構鹹膚廠鹽) = NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE 積蓋願艱蓋襯積衊獵糧 (艱醖醖糧觸膚構衊齋製 )	积极	2020-06-04
				Placebo