ABO2203 / Suzhou Abogen Biosci, Novartis - LARVOL DELTA

Abogen Announces Licensing and Option Agreement with Novartis to Advance mRNA-Encoded T-Cell Engager and other potential RNA programs (PRNewswire) - "The agreement includes an exclusive worldwide license to Abogen's lead asset, ABO2203, as well as options to exclusively license other potential programs leveraging Abogen's proprietary RNA platform. ABO2203 is a novel mRNA-encoded CD19xCD3 T-cell engager with the potential to transform the treatment landscape for patients with autoimmune diseases....Under the agreement, Novartis will also have the exclusive option to license a number of next-generation therapeutic assets developed on Abogen's RNA platform."

Licensing / partnership • Immunology

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

mRNA-encoding CD19-targeting T cell engager for refractory immune thrombocytopenia. (PubMed, Cell) - "ABO2203 is a lipid nanoparticle-formulated messenger RNA (mRNA) encoding a CD19-targeting TCE...B cell reconstitution was observed with predominant transitional and naive B cells. These findings establish mRNA-encoded TCEs as a potent and safer therapeutic modality for B cell-mediated autoimmune diseases."

First-in-human • Journal • Genetic Disorders • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Sjogren's Syndrome • Systemic Lupus Erythematosus • Thrombocytopenia • Thrombocytopenic Purpura

Preclinical to clinical translation of ABO2203, a messenger RNA (mRNA) encoding a CD3 × CD19 T-cell engager (TCE), for refractory autoimmune diseases (AIDs): Preliminary results from the first-in-human clinical trial (EULAR 2026) - P1 | "Patients exhibited fast B-cell depletion in blood and bone-marrow and promising clinical response. Hence, mRNAs encoding TCE might display a wider therapeutic window and represent a promising class of therapeutics that might be administered safely in the outpatient setting."

First-in-human • P1 data • Preclinical • Genetic Disorders • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

ABO2203, a messenger RNA encoding a CD3×CD19 T cell engager, for relapsed/refractory B cell non-Hodgkin lymphoma: Preliminary results from first-in-human study (AACR 2026) - P1 | "Moreover, LNP component had a short half-life (mean 2.4 days), indicative of minimal accumulation risk.ConclusionABO2203 achieved initial clinical proof-of-concept. Its LNP-mRNA platform showed a well-tolerated safety profile and dose-dependent anti-tumor activity in heavily pretreated B-NHL patients, supporting its continual development in B-NHL."

First-in-human • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AACR 2026 Oral Presentation: Abogen Presents Preliminary Results of ABO2203 (mRNA-Encoded CD3×CD19 TCE) from First-in-Human Clinical Study in R/R B-NHL (PRNewswire) - "The presentation included data from nine patients in the dose- escalation stage....ABO2203 was well tolerated across all evaluated dose levels....Objective response rates (ORR) were dose-dependent across cohorts, reaching 33%, 67%, and 100% in the low-, medium-, and high-dose groups, respectively. Complete metabolic responses (CMRs) were observed in both the medium- and high-dose cohorts, with a 100% complete response (CR) rate achieved in the high-dose cohort as updated by Professor Li Wang. Responses were seen across both aggressive (DLBCL) and indolent (FL, MCL, MZL) lymphomas, with a 100% ORR in follicular lymphoma."

First-in-human • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma

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