Delving into the Latest Updates on Rezpegaldesleukin with Synapse

Overview

Basic Info

Drug Type

Cytokines, Fusion protein

Synonyms

IL-2 conjugate, Interleukin-2 conjugate, PEG-conjugated rhIL-2

+ [5]

Target

IL-2Rβ

Mechanism

IL-2Rβ agonists(Interleukin-2 receptor beta chain agonists)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases

Active Indication

Alopecia AreataModerate Atopic DermatitisSevere Atopic Dermatitis+ [2]

Inactive Indication

Colitis, UlcerativeEczemaSystemic Lupus Erythematosus

Originator Organization

Nektar Therapeutics

Active Organization

Nektar TherapeuticsNektar Therapeutics UK Ltd.

Eli Lilly & Co.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 720

Source: *****

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.

Start Date02 Apr 2024

Sponsor / Collaborator

Nektar Therapeutics

NCT06136741 / RecruitingPhase 2

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.

Start Date15 Nov 2023

Sponsor / Collaborator

Nektar Therapeutics

NCT05565729 / CompletedPhase 1

A Phase 1, Randomized, Placebo-controlled, Participant- and Investigator-blind, Single-dose Study of the Pharmacokinetics of LY3471851 Following Subcutaneous Dosing of LY3471851 in Healthy Participants

The purpose of this study is to compare two different formulations (test & reference) of LY3471851 in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving the study drug that is LY3471851.

Start Date05 Oct 2022

Sponsor / Collaborator

Nektar Therapeutics

[+1]

100 Clinical Results associated with Rezpegaldesleukin

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100 Translational Medicine associated with Rezpegaldesleukin

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100 Patents (Medical) associated with Rezpegaldesleukin

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17

Literatures (Medical) associated with Rezpegaldesleukin

01 Sep 2024·ALLERGY

Recent patents in allergy and immunology: The interleukin‐2 receptor pathway agonist rezpegaldesleukin (REZPEG) for the rescue of regulatory T cells in chronic inflammatory and autoimmune diseases

Article

Author: Fanton, Christie ; Zalevsky, Jonathan

A review.A review discussing interleukin-2 receptor pathway agonist rezpegaldesleukin for the rescue of regulatory T cells in chronic inflammatory and autoimmune diseases.It also discusses f these being to achieve effective autoimmune and chronic inflammatory disease management, increased patient compliance, convenience, and tolerability while also minimizing the risk of off-target Tcon stimulation.

01 Jan 2022·Journal of translational autoimmunity

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

Article

Author: 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.

14 Jan 2019·ACS biomaterials science & engineeringQ3 · ENGINEERING & TECHNOLOGY

Folic-Acid-Adorned PEGylated Graphene Oxide Interferes with the Cell Migration of Triple Negative Breast Cancer Cell Line, MDAMB-231 by Targeting miR-21/PTEN Axis through NFκB

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Chattopadhyay, Dipankar ; Ghosh, Avijit ; Upadhyay, Priyanka ; Basu, Arijita ; Adhikary, Arghya

Triple negative breast cancer (TNBC), characterized by its aggressive and highly metastatic nature, is difficult to cure by the currently available therapies. In our investigation, folic-acid-adorned PEGylated graphene oxide (FA-PEG-GO) was synthesized by modifying graphene oxide (GO) with folic acid-PEG conjugate (FA-PEG-NH₂) by EDC/NHS coupling reaction. FA-PEG-GO exhibited an exceptional potential to attenuate cell migration of TNBC cell line ,MDAMB-231 as compared to GO because of the adorned folic acid moiety, which rendered better targeting. FA-PEG-GO inhibited cell migration by actin depolymerization and perturbing lamellipodia formation. The immunocytochemistry and western blot data unraveled the fact that FA-PEG-GO inhibited cell migration by targeting miR-21 by restricting the nuclear translocation of NFκB. The downregulation of miR-21 resulted in the elevation of PTEN expression which sequentially downregulated pFAK resulting in inhibition of cell migration. Moreover, upregulation of PTEN in FA-PEG-GO treated cells led to the decrease in expression of the downstream regulators including pAkt(Ser473) and pERK1/2, which contributed to the retardation of cell migration. Interestingly, the overexpression of NFκB-p65 by the transfection of NFκB-p65 expression plasmid in TNBC cells reversed the inhibitory effect of FA-PEG-GO on the nuclear translocation of NFκB-p65 which stabilized miR-21 expression and successively downregulated PTEN expression in FA-PEG-GO treated cells. Furthermore, miR-21 overexpression by transfection of miR-21 mimic in turn downregulated PTEN expression and sequentially restored the expression of pFAK even upon FA-PEG-GO treatment. miR-21 overexpression also compensated the inhibitory effect of FA-PEG-GO on pAkt(Ser473) and pERK1/2 which was evident from their significant expression in FA-PEG-GO-treated cells. The studies on chick embryo model ratified the ex ovo antimigratory efficacy of FA-PEG-GO. Altogether, our study unveiled the enormous potential of FA-PEG-GO to attenuate migration of TNBC cell line, MDAMB-231 by targeting the miR-21/PTEN axis through NFκB and thereby providing insights on cancer treatment.

62

News (Medical) associated with Rezpegaldesleukin

08 Dec 2024

·pipelinereview.com

Nektar Therapeutics Announces NKTR-255 Following CD19-directed CAR-T Therapy Enhanced Complete Response Rates in Patients with Relapsed or Refractory Large B-cell Lymphoma at the 66th Annual ASH Meeting

73% of the NKTR-255 treatment group compared to 50% of the placebo group achieved a complete response at 6 months NKTR-255 enhanced CAR T-cell kinetics with improved CD8+ CAR-T area under the curve (AUC) 0-15 days post-administration being 5.8-fold greater than placebo-controls SAN FRANCISCO, CA, USA I December 7, 2024 I Nektar Therapeutics (Nasdaq: NKTR ) today announced results of its Phase 2 proof-of-concept study evaluating NKTR-255 as an adjuvant treatment to enhance complete response rate (CRR) and durability following CD19-directed CAR-T therapy in patients with relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL) at the 66 th ASH Annual Meeting and Exposition in San Diego, California. NKTR-255 is an investigational polymer-conjugated IL-15 agonist, that activates, proliferates and expands natural killer (NK) and CD8+ T-cells in vivo , as well as promotes the survival and expansion of memory CD8+ T cells intended to increase duration and level of response for CAR-T and cellular therapies. 1,2 In this multicenter, double-blind Phase 2 study, patients were randomized to receive one of three dose regimens of NKTR-255 or placebo intravenously starting 14 days after CAR-T infusion. In the fifteen-person clinical trial, the NKTR-255 combined treatment group demonstrated an improved CRR at six months, achieving 73% compared to 50% for the placebo, as assessed by a blinded independent central radiology review. Additionally, two patients treated with NKTR-255 converted from stable disease or partial response to complete responses at six months. No conversions from stable disease or partial response to complete response were observed in the placebo arm of the trial. “The majority of patients currently receiving CAR-T therapies fail to achieve durable disease remission,” said Sairah Ahmed, M.D., Associate Professor, Director of CAR-T Program at the Department of Lymphoma/Myeloma, Division of Cancer Medicine at University of Texas MD Anderson Cancer Center. “The results of this study demonstrated that NKTR-255 enhanced CAR T-cell counts and increased the number of patients who achieve a CR at 6 months post infusion. This finding is highly significant since, in multiple pivotal trials, patients who achieved complete response at 6 months were highly likely to remain in complete response beyond 2 years translating to improved progression-free survival.” The reported clinical benefit surpasses the published historical benchmark data from multiple pivotal trials and real-world meta-analyses of currently available commercial CD19 CAR-T cell therapies, which demonstrate 6-month complete response rates of 41% to 44%. “This study is the first randomized trial demonstrating adjuvant treatment with NKTR-255 can enhance the durability of response to standard-of-care commercial CAR T-cell therapy by modifying CAR T-cell kinetics,” said Mary Tagliaferri, M.D., Chief Medical Officer of Nektar. “These results contribute to the growing body of evidence demonstrating the broad applicability of NKTR-255 in combination with cellular therapies, and, as new data emerge, we continue to explore the best path forward for this program.” NKTR-255 was safe and well-tolerated in patients with relapsed/refractory LBCL in combination with FDA-approved CD19 CAR T-cell products. Details of the presentation can be found on Nektar’s website at www.nektar.com under Scientific Posters, Presentations and Publications. Title: 2068 NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/ Refractory (R/R) Large B-Cell Lymphoma (LBCL) Poster: 2068 Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I Hematology Disease Topics & Pathways: Research, Clinical trials, Clinical Research Time & Date: Saturday, December 7, 2024, 5:30 PM-7:30 PM About NKTR-255 NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body’s innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response. In addition to studies in combination with CAR T cell therapies, NKTR-255 is being studied in a Phase 1 clinical trial sponsored by AbelZeta Pharma, Inc., which is evaluating C-TIL051, a tumor-infiltrating lymphocyte therapy, in anti-PD1 resistant metastatic non-small cell lung cancer (NCT05676749). The JAVELIN Bladder Medley study (NCT05327530), sponsored by Merck KGaA, is also ongoing to evaluate NKTR-255 in combination with avelumab as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (NCT05327530). 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 www.nektar.com and follow Nektar on LinkedIn . SOURCE: Nektar Therapeutics

Clinical ResultCell TherapyPhase 2ImmunotherapyPhase 1

07 Dec 2024

·www.prnewswire.com

Nektar Therapeutics Announces NKTR-255 Following CD19-directed CAR-T Therapy Enhanced Complete Response Rates in Patients with Relapsed or Refractory Large B-cell Lymphoma at the 66th Annual ASH Meeting

73% of the NKTR-255 treatment group compared to 50% of the placebo group achieved a complete response at 6 months NKTR-255 enhanced CAR T-cell kinetics with improved CD8+ CAR-T area under the curve (AUC) 0-15 days post-administration being 5.8-fold greater than placebo-controls SAN FRANCISCO, Dec. 7, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced results of its Phase 2 proof-of-concept study evaluating NKTR-255 as an adjuvant treatment to enhance complete response rate (CRR) and durability following CD19-directed CAR-T therapy in patients with relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL) at the 66th ASH Annual Meeting and Exposition in San Diego, California. NKTR-255 is an investigational polymer-conjugated IL-15 agonist, that activates, proliferates and expands natural killer (NK) and CD8+ T-cells in vivo, as well as promotes the survival and expansion of memory CD8+ T cells intended to increase duration and level of response for CAR-T and cellular therapies.1,2 In this multicenter, double-blind Phase 2 study, patients were randomized to receive one of three dose regimens of NKTR-255 or placebo intravenously starting 14 days after CAR-T infusion. In the fifteen-person clinical trial, the NKTR-255 combined treatment group demonstrated an improved CRR at six months, achieving 73% compared to 50% for the placebo, as assessed by a blinded independent central radiology review. Additionally, two patients treated with NKTR-255 converted from stable disease or partial response to complete responses at six months. No conversions from stable disease or partial response to complete response were observed in the placebo arm of the trial. "The majority of patients currently receiving CAR-T therapies fail to achieve durable disease remission," said Sairah Ahmed, M.D., Associate Professor, Director of CAR-T Program at the Department of Lymphoma/Myeloma, Division of Cancer Medicine at University of Texas MD Anderson Cancer Center. "The results of this study demonstrated that NKTR-255 enhanced CAR T-cell counts and increased the number of patients who achieve a CR at 6 months post infusion. This finding is highly significant since, in multiple pivotal trials, patients who achieved complete response at 6 months were highly likely to remain in complete response beyond 2 years translating to improved progression-free survival." The reported clinical benefit surpasses the published historical benchmark data from multiple pivotal trials and real-world meta-analyses of currently available commercial CD19 CAR-T cell therapies, which demonstrate 6-month complete response rates of 41% to 44%. "This study is the first randomized trial demonstrating adjuvant treatment with NKTR-255 can enhance the durability of response to standard-of-care commercial CAR T-cell therapy by modifying CAR T-cell kinetics," said Mary Tagliaferri, M.D., Chief Medical Officer of Nektar. "These results contribute to the growing body of evidence demonstrating the broad applicability of NKTR-255 in combination with cellular therapies, and, as new data emerge, we continue to explore the best path forward for this program." NKTR-255 was safe and well-tolerated in patients with relapsed/refractory LBCL in combination with FDA-approved CD19 CAR T-cell products. Details of the presentation can be found on Nektar's website at under Scientific Posters, Presentations and Publications. Title: 2068 NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/ Refractory (R/R) Large B-Cell Lymphoma (LBCL) Poster: 2068 Program: Oral and Poster Abstracts Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I Hematology Disease Topics & Pathways: Research, Clinical trials, Clinical Research Time & Date: Saturday, December 7, 2024, 5:30 PM-7:30 PM About NKTR-255 NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body's innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response. In addition to studies in combination with CAR T cell therapies, NKTR-255 is being studied in a Phase 1 clinical trial sponsored by AbelZeta Pharma, Inc., which is evaluating C-TIL051, a tumor-infiltrating lymphocyte therapy, in anti-PD1 resistant metastatic non-small cell lung cancer (NCT05676749). The JAVELIN Bladder Medley study (NCT05327530), sponsored by Merck KGaA, is also ongoing to evaluate NKTR-255 in combination with avelumab as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (NCT05327530). 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," "anticipate," "can," 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, 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 NKTR-255 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) NKTR-255 is an investigational agent and continued research and development for this drug candidate 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) NKTR-255 is 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) 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 (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2024. 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. For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: Madelin Hawtin LifeSci Communications 603-714-2638 [email protected] Shah, N., Perales, M. A., Turtle, C. J., Cairo, M. S., Cowan, A. J., Saeed, H., … Patel, K. K. (2021). Phase I Study Protocol: NKTR-255 as Monotherapy or Combined with Daratumumab or Rituximab in Hematologic Malignancies. Future Oncology, 17(27), 3549–3560. Miyazaki T, Maiti M, Hennessy M, et al. NKTR-255, a novel polymer-conjugated rhIL-15 with potent antitumor efficacy. Journal for ImmunoTherapy of Cancer 2021;9:e002024. doi:10.1136/jitc-2020-002024 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

$Nektar Therapeutics Announces NKTR-255 Following CD19-directed CAR-T Therapy Enhanced Complete Response Rates in Patients with Relapsed or Refractory Large B-cell Lymphoma at the 66th Annual ASH Meeting$

Clinical ResultImmunotherapyPhase 2Cell TherapyPhase 1

02 Dec 2024

·www.prnewswire.com

Ampersand Capital Partners Completes Acquisition of Nektar Therapeutics' PEG Reagent Manufacturing Business, Launching Newly Branded Gannet BioChem

BOSTON and HUNTSVILLE, Ala., Dec. 2, 2024 /PRNewswire/ -- Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the life sciences and healthcare sectors, today announced the successful closing of its previously announced acquisition of Nektar Therapeutics' PEGylation reagent manufacturing business. The new Ampersand portfolio company will be branded Gannet BioChem and will continue to operate out of its state-of-the-art facility in Huntsville, Alabama. Continue Reading Gannet BioChem With over 30 years of expertise, Gannet BioChem is a proven specialty CDMO leader in developing, scaling, and manufacturing polyethylene glycol (PEG) reagents - critical components in advanced biopharmaceutical and therapeutic products. Gannet BioChem combines industry-leading expertise and cutting-edge infrastructure to deliver unparalleled capabilities: End-to-End GMP Production: From raw material sourcing to manufacturing and packaging, ensuring exceptional quality and reliability across every stage of the supply chain. FDA-Approved Applications: Development and production of PEG reagents used in nine FDA-approved therapeutics over facility's history. Commercial Impact: Supplying PEG reagents for several currently marketed drugs. Flexible Facility: Designed to efficiently handle small-scale and commercial-scale production needs. Expert Team: An experienced workforce with an average tenure of 13 years, ensuring consistent quality and innovation. Expansion-Ready Infrastructure: A 124,000 sq. ft. manufacturing facility with dedicated small and large-scale production areas and operational capacity for future growth. Strategic Location: Situated in Huntsville, Alabama, Gannet BioChem benefits from its proximity to the USA's second-largest life sciences research park, providing a robust ecosystem for collaboration and innovation in biotechnology. Legacy of Quality: Gannet BioChem's FDA-inspected facility maintains an exceptional compliance record, underlining its commitment to quality and reliability for customers worldwide. "We are thrilled to introduce Gannet BioChem as a new, independent PEG reagents CDMO," said David Anderson, General Partner at Ampersand Capital Partners. "The PEG reagent manufacturing team at Gannet BioChem has a well-established track record and long history of delivering high-quality, specialized PEG reagents for commercial and clinical stage biologic therapeutics. We are well-equipped to build on that legacy with the support of Ampersand's resources and expertise in life sciences partnerships. Gannet BioChem is poised for continued success and strategic growth as a trusted partner to biopharmaceutical innovators globally." About Ampersand Capital Partners Ampersand Capital Partners, founded in 1988, is a middle-market private equity firm with $3 billion of assets under management, dedicated to growth-oriented investments in the healthcare sector. With offices in Boston, MA, and Amsterdam, Netherlands, Ampersand leverages a unique blend of private equity and operating experience to build value and drive long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. For additional information, visit AmpersandCapital.com or follow us on LinkedIn. About Gannet BioChem With over 30 years of expertise, Gannet BioChem is a leading specialty CDMO specializing in the development, scaling, and manufacturing of polyethylene glycol (PEG) reagents—essential components in advanced biopharmaceutical and therapeutic products. Operating from a state-of-the-art 124,000 sq. ft. FDA-inspected facility in Huntsville, Alabama, Gannet BioChem delivers end-to-end GMP production, supporting clinical and commercial therapeutics. With a highly experienced team, flexible production capabilities, and a commitment to quality, Gannet BioChem provides reliable, innovative solutions to meet the evolving needs of the global biopharmaceutical industry. For additional information, please visit GannetBioChem.com or follow us on LinkedIn. 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. SOURCE Ampersand Capital Partners WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Acquisition

100 Deals associated with Rezpegaldesleukin

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alopecia Areata	Phase 2	US	Nektar Therapeutics	02 Apr 2024
Alopecia Areata	Phase 2	CA	Nektar Therapeutics	02 Apr 2024
Moderate Atopic Dermatitis	Phase 2	US	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	AU	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	BG	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	CA	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	HR	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	CZ	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	DE	Nektar Therapeutics	15 Nov 2023
Moderate Atopic Dermatitis	Phase 2	HU	Nektar Therapeutics	15 Nov 2023

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04433585 (ISLAND-SLE, CTgov)	Phase 2	Systemic Lupus Erythematosus	291	LY3471851 (LY3471851 High Dose)	zlukbdnuke(ugjazyjvdz) = uwjwfrvcqu benvunsygy (agqafzbslv, zqajrxhfkw - qebuewjnti) View more	-	23 Apr 2024
				LY3471851 (LY3471851 Mid Dose)	zlukbdnuke(ugjazyjvdz) = pratskdlno benvunsygy (agqafzbslv, sxnhqsivjt - lrwwlmqijm) View more
NCT04081350 (Phase 1b study, EADV2023)	Phase 1	Dermatitis, Atopic Treg	-	Rezpegaldesleukin 12 µg/kg	odccuveodi(ejbqzailkk) = bugaqgyrci ddsqqotcds (vvgnuvxdck ) View more	Positive	11 Oct 2023
				Rezpegaldesleukin 24 µg/kg	odccuveodi(ejbqzailkk) = xxilpmphme ddsqqotcds (vvgnuvxdck ) View more
NCT04677179 (INSTRUCT-UC, CTgov)	Phase 2	Colitis, Ulcerative	81	Placebo (Placebo (Induction Treatment Period))	ebxuakkbsq(ioiyuklvsw) = spbnlgupqo vfsiyrkijg (qmobrvdhrs, gftaumheti - wrvaxsmtqc) View more	-	05 Sep 2023
				LY3471851 (Low Dose LY3471851 (Induction Treatment Period))	ebxuakkbsq(ioiyuklvsw) = ocmaicgelc vfsiyrkijg (qmobrvdhrs, yoqjdkgiqw - hahhqghkub) View more
NCT04433585 (ISLAND-SLE, Corporate Publications) Manual	Phase 2	Systemic Lupus Erythematosus	291	rezpegaldesleukin 300mcg Q2W	zcibtikwsh(xzletrmeex) = fikvfsnjnr wklvseakxc (eqwswbwjny ) View more	Negative	23 Feb 2023
				rezpegaldesleukin 900mcg Q2W	zcibtikwsh(xzletrmeex) = leknozyvtd wklvseakxc (eqwswbwjny ) View more
NCT04081350 (Corporate Publications) Manual	Phase 1	Dermatitis, Atopic	43	LY3471851 12 µg/kg	pherdhfixh(cglkfvgpos) = qjqxgqizdf sybfwzmboq (psizxebxag ) View more	Positive	07 Sep 2022
				LY3471851 24 µg/kg	pherdhfixh(cglkfvgpos) = fjgehrzfat sybfwzmboq (psizxebxag ) View more
NCT04119557 (Corporate Publications) Manual	Phase 1	Psoriasis	26	LY3471851	rhyycnngdl(tljybngrpm) = zlwdzfmjlk vinmksobqi (kzgsvcxfnp ) View more	Positive	07 Sep 2022
				Placebo	rhyycnngdl(tljybngrpm) = gbwstlilnz vinmksobqi (kzgsvcxfnp ) View more
NCT03556007 (Corporate Publications) Manual	Phase 1	Systemic Lupus Erythematosus	48	NKTR-358	lqkaojmicv(qliybzzmoc) = NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE vfdhqjmjuk (pkrvlrgyxe )	Positive	04 Jun 2020
				Placebo
ACR2019	Not Applicable	Autoimmune Diseases	-	NKTR-358 0.3 µg/kg	yzpmehtjzh(diezdzpeua) = increased at doses >20 μg/kg tlhjxgkyhl (xmioiiswjl ) View more	-	10 Nov 2019
				NKTR-358 3.0 µg/kg