Nektar Therapeutics Presents First Preclinical Data from Novel CSF-1 Program, NKTR-422, at 2024 American College of Rheumatology (ACR) Convergence
Nektar Therapeutics (NKTR) presented preclinical data for NKTR-422, a novel modified CSF protein, at the 2024 ACR conference. The drug demonstrated promising results in inflammation resolution and tissue repair across multiple preclinical models. NKTR-422 functions by targeting anti-inflammatory tissue resident macrophages and shows a differentiated PK/PD profile compared to native CSF-1 cytokine, requiring only single doses rather than multiple daily administrations. The compound showed potential to enhance efficacy when combined with inflammatory cytokine blockade treatments in rodent models.
Nektar Therapeutics (NKTR) ha presentato dati preclinici per NKTR-422, una nuova proteina CSF modificata, alla conferenza ACR 2024. Il farmaco ha mostrato risultati promettenti nella risoluzione dell'infiammazione e nella riparazione dei tessuti in diversi modelli preclinici. NKTR-422 agisce mirando ai macrofagi residenti nel tessuto con effetto anti-infiammatorio e presenta un profilo PK/PD differenziato rispetto alla citochina CSF-1 nativa, richiedendo solo dosi singole invece di somministrazioni quotidiane multiple. Il composto ha mostrato un potenziale per migliorare l'efficacia quando combinato con trattamenti di blocco delle citochine infiammatorie in modelli di roditori.
Nektar Therapeutics (NKTR) presentó datos preclínicos para NKTR-422, una nueva proteína CSF modificada, en la conferencia ACR 2024. El fármaco mostró resultados prometedores en la resolución de la inflamación y la reparación de tejidos en varios modelos preclínicos. NKTR-422 funciona al dirigirse a los macrófagos residentes en el tejido con propiedades antiinflamatorias y muestra un perfil PK/PD diferenciado en comparación con la citoquina CSF-1 nativa, requiriendo solo dosis únicas en lugar de múltiples administraciones diarias. El compuesto mostró potencial para mejorar la eficacia cuando se combina con tratamientos de bloqueo de citoquinas inflamatorias en modelos de roedores.
Nektar Therapeutics (NKTR)는 2024 ACR 회의에서 새로운 수정된 CSF 단백질인 NKTR-422에 대한 전임상 데이터를 발표했습니다. 이 약물은 여러 전임상 모델에서 염증 해결 및 조직 수리에 대해 유망한 결과를 보였습니다. NKTR-422는 항염증성 조직 거주 대식세포를 표적으로 하여 작용하며, 자연적인 CSF-1 사이토카인에 비해 차별화된 PK/PD 프로필을 보여 주며, 여러 번의 일일 투여가 아닌 단일 용량만으로도 효과를 나타냅니다. 이 화합물은 설치류 모델에서 염증성 사이토카인 차단 치료와 결합했을 때 효능을 향상시킬 가능성을 보여주었습니다.
Nektar Therapeutics (NKTR) a présenté des données précliniques sur NKTR-422, une nouvelle protéine CSF modifiée, lors de la conférence ACR 2024. Le médicament a montré des résultats prometteurs dans la résolution de l'inflammation et la réparation des tissus dans plusieurs modèles précliniques. NKTR-422 agit en ciblant les macrophages résidents anti-inflammatoires et montre un profil PK/PD différencié par rapport à la cytokine CSF-1 native, nécessitant seulement des doses uniques plutôt que plusieurs administrations quotidiennes. Le composé a montré un potentiel d'amélioration de l'efficacité lorsqu'il est associé à des traitements de blocage des cytokines inflammatoires dans des modèles de rongeurs.
Nektar Therapeutics (NKTR) stellte auf der ACR-Konferenz 2024 präklinische Daten zu NKTR-422, einem neuartigen modifizierten CSF-Protein, vor. Das Medikament zeigte vielversprechende Ergebnisse bei der Auflösung von Entzündungen und der Gewebereparatur in verschiedenen präklinischen Modellen. NKTR-422 wirkt, indem es entzündungshemmende residenten Gewebemakrophagen angreift, und weist im Vergleich zur nativen CSF-1-Zytokine ein differenziertes PK/PD-Profil auf, das nur eine Einzeldosis anstelle mehrerer täglicher Verabreichungen erfordert. Die Verbindung zeigte Potenzial zur Verbesserung der Wirksamkeit in Kombination mit entzündungshemmenden Zytokinblockadebehandlungen in Tiermodellen.
- NKTR-422 demonstrated successful inflammation resolution in preclinical models
- Drug requires single dose administration versus multiple daily doses of existing treatments
- Shows potential for enhanced efficacy when combined with existing treatments
- Still in early preclinical stage, far from market approval
- No human trial data available yet
Insights
The preclinical data for NKTR-422 shows interesting potential in treating chronic inflammatory conditions through a novel mechanism targeting tissue resident macrophages. The key differentiator is its improved pharmacokinetic profile requiring less frequent dosing compared to existing CSF-1 treatments. However, these are very early-stage results with significant development hurdles ahead.
While the data demonstrates both inflammation resolution and tissue repair capabilities, particularly noteworthy when combined with existing treatments, investors should recognize that preclinical success often doesn't translate to human trials. For a small-cap biotech like Nektar (
The broad potential applications across inflammatory conditions could provide significant market opportunity, but substantial funding will be needed to advance clinical development. Given Nektar's resources, partnership discussions may be important for this program's future.
- NKTR-422 demonstrated inflammation resolution and tissue repair in multiple preclinical models of chronic inflammatory conditions -
NKTR-422 is a novel modified hematopoietic colony stimulating factor (CSF) protein engineered to selectively modulate resolution processes of inflammation by targeting the expansion, reprograming and activation of anti-inflammatory tissue resident macrophages.
Currently approved inflammatory disease therapies are not designed to achieve inflammation resolution or tissue repair, which are both required for remission.1 Nektar has identified a CSF-1R agonist with a differentiated pharmacokinetic (PK)/pharmacodynamic (PD) profile compared to the native CSF-1 cytokine. Reduced clearance enables sustained PD activity from a single dose, unlike historical multiple dose per day necessary regimens of recombinant human CSF-1 administration. This CSF-1R agonist, NKTR-422, demonstrated inflammation resolution and tissue repair markers induction in tissue resident macrophages without induction of monocytosis and enhanced the efficacy of inflammatory cytokine blockade in rodent models.
"These early data demonstrate that NKTR-422 has the potential to accelerate treatment efficacy and may improve disease remission, especially in combination treatments with standard of care inflammatory cytokine blockade drugs," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "We're excited to see how this program progresses given its wide potential applications in a number of therapeutic indications including acute and chronic inflammation."
Details of the presentation can be found on Nektar's website at www.nektar.com under Scientific Posters, Presentations and Publications.
2024 American College of Rheumatology (ACR) Convergence
Abstract 1866120: "A Novel Therapeutically Active CSF-1R Agonist Promotes Tissue Macrophages Inflammation Resolution and Induces Tissue Repair Pathways", Kivimae, S.
Presentation Type: Oral
Session: Abstracts: Cytokines & Cell Trafficking
Presentation Time: Monday, November 18 at 3:15 PM - 3:30 PM EST
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. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. 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
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," 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-422. 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-422 are based on preclinical findings and observations and are subject to change as research and development continue; (ii) NKTR-422 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-422 is in preclinical 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
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- Ramírez-Valle, F., Maranville, J.C., Roy, S. et al. Sequential immunotherapy: towards cures for autoimmunity. Nat Rev Drug Discov 23, 501–524 (2024). https://doi.org/10.1038/s41573-024-00959-8
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FAQ
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