Drug intelligence / Profile preview

epsi-gam

Development stage
Unknown
Lead developer
Tunitas Therapeutics
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

epsi-gam (also known as T-101) is a recombinant bifunctional fusion protein developed by Tunitas Therapeutics for the treatment of allergic diseases. It consists of the Fc domains of human IgE and IgG1, designed to simultaneously bind and cross-link the high-affinity IgE receptor (FcεRI) and the inhibitory IgG receptor (FcγRIIb) on the surface of mast cells and basophils. This co-aggregation recruits the phosphatase SHIP to the FcεRI signaling complex, thereby inhibiting the release of histamine and other inflammatory mediators. This mechanism is allergen-agnostic, meaning it can potentially treat multiple allergies (such as cat, dust mite, and Bermuda grass) by silencing the effector cells regardless of the specific allergen trigger. Although it completed a Phase 1 dose-escalation study (NCT02230059), development appears to have ceased following the inactivity of Tunitas Therapeutics.

Other names
IgE-IgG fusion protein
02

Targets

FCGR2B (Fc gamma receptor IIB)FCER1A (Fc epsilon receptor I alpha)

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