Pipeline

About ZB-168

ZB-168

ZB-168

ZB-168 is a fully human-IgG1 monoclonal antibody targeted against the IL-7Rα, which plays a key role in the development, function and homeostasis of T cells. We believe ZB-168 may be a therapeutic option for autoimmune diseases where IL-7 or TSLP signaling has been implicated.

ZB-168 has been well tolerated to date. In 93 subjects dosed with ZB-168 to date, the majority of adverse events (“AEs”) were categorized as grade 1 or grade 2. There were no deaths or permanent discontinuations due to AEs.

Zura Bio holds an exclusive worldwide license for the development and commercialization of ZB-168 in all indications.

It is the only anti-IL-7Rα program to date with clinical data showing impact on key T-cell subpopulations, underscoring its potential applicability in a broad range of T-cell mediated diseases and atopic diseases.

We plan to conduct necessary CMC and regulatory activities to prepare ZB-168 for Phase 2 readiness. Additionally, we are actively monitoring Phase 2 IL-7R external catalysts along with additional TSLP-driven catalysts.

IL-7 and TLSP Pathways

IL-7Rα: A unique target for modulating two key immune pathways

IL-7 Pathway

IL-7 is a critical modulator of T-cell homeostasis,
proliferation, and survival

Inhibition of IL-7Rα promotes a normalisation in Treg :Teffector T-cell ratios

Polymorphism in IL-7Rα associated with multiple disease states, including T1DM, MS, UC, Sarcoidosis PBC and AA

TSLP Pathway

Is a regulator of Th2 immune response

Is involved in immunity at barrier surfaces
(skin, airways, gut)

Is clinically validated for the treatment of
severe asthma

Is under clinical investigation in CSU, COPD,
and chronic rhinosinusitis

IL7 TLSP Pathways

References

  1. Immunomodulatory activity of humanized anti–IL-7R monoclonal antibody RN168 in subjects with type 1 diabetes
    Herold et al, JCI Insight. 2019;4(24):e126054. https://doi.org/10.1172/jci.insight.126054
  2. Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 Diabetes
    Williams, J.H., Udata, C., Ganguly, B.J. et al. AAPS J 22, 23 (2020). https://doi.org/10.1208/s12248-019-0401-3
  3. Blockade of IL-7 signaling suppresses inflammatory responses and reverses alopecia areata in C3H/HeJ mice
    Dai, Zhenpeng et al. Science advances vol. 7,14 eabd1866. 2 Apr. 2021. doi: 10.1126/sciadv.abd1866.