Pipeline

Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells, reported positive data from the Phase 1b EQUATE study in patients with acute graft-versus-host disease (aGVHD) and is now being evaluated in the Phase 3 EQUATOR study. It is also being evaluated in the EQUALISE Phase 1b study for patients with lupus/lupus nephritis.

EQ101 is a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, three inflammatory cytokines implicated in multiple diseases. It selectively blocks those three key pathogenic cytokines while preserving non-pathogenic signaling related to IL-4, IL-7 and IL-21 and has demonstrated clinical proof-of-concept as a novel cytokine inhibitor through a completed Phase 1/2 study in cutaneous T cell lymphoma (CTCL), a dermato-oncology indication.

EQ102 is a first-in-class, selective inhibitor of IL-15 and IL-21. It has undergone substantial translational work supporting its potential use as a treatment for various gastrointestinal diseases and is Phase 1 ready for a study planned to include a proof-of-concept evaluation in patients with celiac disease, an immune disorder related to gluten exposure. EQ102 is currently formulated for subcutaneous administration where it is positioned to address an unmet need in patients experiencing symptoms despite attempts to maintain a gluten-free diet.

Pipeline Overview

Drug

Indication & Delivery

Discovery & Pre-Clinical

Pre-Clinical

Phase 1

Phase 2

Phase 3

Status & Designations

EQ001
Itolizumab

anti-CD6

acute graft-versus-host disease

intravenous
  • Phase 3 initiated Q1 2022
  • Pivotal study to support BLA filing
  • FDA FastTrack and Orphan Drug Designations

systemic lupus erythematosus (SLE) / lupus nephritis (LN)

subcutaneous
  • Interim data expected mid-2022
  • Phase 1b study
    actively enrolling
  • FDA FastTrack Designation

EQ101

IL-2/9/15
antagonist

alopecia areata

intravenous & subcutaneous
  • Phase 2 Study initiation
    expected during 2H 2022
  • Clinical PoC in Phase 1/2 CTCL study
  • Open IND for Phase 2a study
  • Subcutaneous delivery in development

EQ102

IL-15/21
antagonist

nhv / celiac disease

subcutaneous
  • Phase 1 initiation
    expected 2H 2022
  • Phase 1 study expected to include PoC in celiac disease
  • Potential expanstion into other GI

Additional
Products

immunology & inflammatory disorders

  • Phase 1 initiation
    expected 2H 2022
  • Broad potential including additional cytokine families and orally-delivered peptides

Pipeline Overview

Drug

EQ001 Itolizumab anti-CD6

acute graft-versus-host disease

intravenous

Indication & Delivery

Discovery & Pre-Clinical

Phase 1

Phase 2

Phase 3

  • Phase 3 initiated Q1 2022

Status & Designations

  • Pivotal study to support BLA filing
  • FDA FastTrack and Orphan Drug Designations

systemic lupus erythematosus (SLE) / lupus nephritis (LN)

subcutaneous

Indication & Delivery

Delivery & Pre-Clinical

Phase 1

Phase 2

Phase 3

  • Interim data expected
    mid 2022

Status & Designations

  • Phase 1b study actively enrolling
  • FDA FastTrack Designation

Drug

EQ101 Itolizumab IL-2/9/15 antagonist

alopecia areata

Indication & Delivery

Delivery & Pre-Clinical

Phase 1

Phase 2

Phase 3

  • Phase 2 Study initiation expected
    during 2H 2022

Status & Designations

  • Clinical PoC in phase 1/2 CTCL study
  • Open IND for Phase 2a study
  • Subcutaneous delivery in development

Drug

EQ102 IL-15/21 antagonist

celiac disease

subcutaneous

Indication & Delivery

Delivery & Pre-Clinical

Phase 1

Phase 2

Phase 3

  • Phase 1 initiation
    expected 2H 2022

Status & Designations

  • Phase 1 PoC Study expected to include PoC in celiac disease
  • Potential expansion into other GI

Drug

Additional Products

immunology & inflammatory disorders

Indication & Delivery

Delivery & Pre-Clinical

Phase 1

Phase 2

Phase 3

Status & Designations

  • Broad potential including additional cytokine families and orally-delivered peptides