ABO-203 / Arbor Biotech - LARVOL DELTA

ABO2203, an mRNA-Encoded CD3×CD19 T-Cell Engager (TCE), Mediates Deep B-Cell Depletion and Clinical Improvement in Systemic Sclerosis (SSc): First-in-Human Results (ACR Convergence 2026) - P1 | "All 5 SSc pts attained an ACR-CRISS score ≥ 0.600 (range: 0.863-1.000) as early as Week 4, including one rituximab-refractory pt, with responses maintained at the latest assessment (Figure 1). ABO2203 provides a favorable safety profile and achieves rapid, durable B-cell depletion in refractory SSc pts without corticosteroid premedication. The marked, early clinical improvements highlight this mRNA-encoded TCE as a highly promising therapeutic strategy for SSc, supporting its continued clinical evaluation."

Clinical • First-in-human • P1 data • Immunology • Infectious Disease • Inflammation • Scleroderma • Systemic Sclerosis

Arbor Biotechnologies, Inc…announced the nomination of three CNS-focused development candidates: ABO-201 for familial ALS, and ABO-202 and ABO-203 for sporadic ALS. (GlobeNewswire) - "First CNS investigational new drug (IND) filings are anticipated in 2027."

IND • New molecule • Amyotrophic Lateral Sclerosis

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Ruijin Hospital | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Nov 2026 ➔ Nov 2027

Trial completion date • Trial primary completion date • Immunology

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Ruijin Hospital | N=26 ➔ 66

Enrollment change • Immunology

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Ruijin Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Ruijin Hospital

New P1 trial • Immunology

A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Ruijin Hospital

New P1 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology