Pipeline

One antibody, a staged path to approval

The lead program in acute GvHD is funded through the EIC Accelerator and targets Phase 2b on a conditional approval pathway. Around it, a staged set of expansion programs extends selective Treg activation into dermatology, rheumatology and lung disease.

Development status

Tregalizumab programs

Six programs, one mechanism: selective activation of regulatory T cells.

Oncology · EIC Accelerator-funded program

Acute Graft-versus-Host Disease (aGvHD)

Transplanted donor immune cells attack the recipient's skin, liver, and GI tract — potentially life-threatening. U.S. Orphan Drug Designation granted.

EIC Accelerator-funded — grant: platform de-risking · equity: Phase 2b clinical PoC
Target: Phase 2b · conditional approval pathway

Immune-Dermatology / Rheumatology · Short-term expansion

Oral Lichen Planus (oLP) — PoCC program

Chronic autoimmune inflammation of the oral mucosa causing painful ulcerations.

CD4 Therapeutics-sponsored — short-term expansion
Target: Phase 2b

bDMARD-Refractory Rheumatoid Arthritis (RA)

~30–40% of RA patients on adalimumab lose response within ~12–18 months; ~15–25% of bDMARD failures are refractory to any later-line treatment.

CD4 Therapeutics-sponsored — short-term expansion
Entering pilot Phase 2

Immune-Dermatology / Lung Diseases · Long-term expansion

Vulvar/Genital Lichen Sclerosus (vLS) — post-oLP scale-up (PoCC)

Autoimmune skin condition causing white, thinning anogenital patches with pain or scarring.

CD4 Therapeutics-sponsored — long-term expansion / scale-up
Entering Phase 2b

Allergic Bronchopulmonary Aspergillosis (ABPA)

Allergic lung reaction to Aspergillus fungi causing airway inflammation.

CD4 Therapeutics-sponsored — long-term expansion program
Target: Phase 1

Chronic Obstructive Pulmonary Disease (COPD)

Chronic lung condition from long-term inflammation that damages lung tissue.

CD4 Therapeutics-sponsored — long-term expansion program
Target: Phase 1

Program status as presented by CD4 Therapeutics, July 2026. Bars indicate the phase reached or targeted per program, not elapsed time.

Structure

A staged expansion strategy

Lead program

Acute GvHD, EIC Accelerator-funded

60% of stem cell transplant patients develop acute GvHD; more than half fail first-line steroids. Phase 2b on a conditional approval pathway, with U.S. Orphan Drug Designation and the graft-versus-leukemia effect preserved.

Target: Phase 2b

Short-term expansion

Oral lichen planus, refractory RA

oLP: chronic, pre-malignant inflammation with no approved therapy, 3M+ patients worldwide. RA: clinical proof-of-concept already achieved with Tregalizumab.

Phase 2b target and pilot Phase 2

Long-term expansion

Lichen sclerosus, ABPA, COPD

Scale-up programs extending selective Treg activation into further immune-driven skin and lung disease.

Entering Phase 2b and targeting Phase 1