Budoprutug and CD-19

Budoprutug is an anti-CD19 mAb designed to result in durable and potent B cell depletion, based on long dosing intervals, and with potential for intravenous (IV) and subcutaneous (SC) formulations. CD19 is an attractive target relevant to multiple B cell-mediated diseases, as it is expressed across the entire B cell lineage, including autoantibody-secreting cells. The broad CD19 expression profile may enable comprehensive, rapid, and durable depletion of pathogenic B cells, while preserving protective antibody responses mediated by long-lived plasma cells. Targeting CD19 could provide significant clinical benefits compared to other immune cell markers.

Budoprutug is a Highly Potent, Fc-Enhanced Anti-CD19 mAb

Designed for optimal biological activity, with a specialized formulation that may enable the development
of both intravenous and subcutaneous delivery.

A completed budoprutug Phase 1b study demonstrated proof of concept and a favorable safety profile

  • Rapid and complete B cell depletion observed in 100% of pMN patients (n=5) at doses of 100-200mg
  • Serologic Remission Anti-PLA2R antibody negativity achieved in 100% (3/3) evaluable patients
  • Led to Clinical Remission with all patients (5/5) achieving complete or partial clinical remission by Week 48, as measured by Urine Protein Creatine Ratio (UPCR)
  • Budoprutug was generally well tolerated at doses of up to 200mg, supporting exploration of higher doses in future studies
Rapid and complete B cell depletion observed in Phase 1b study

Our budoprutug development strategy

We are developing budoprutug across multiple disease categories, pursuing lead indications with high unmet need, clear B-cell driven pathology and large therapeutic and commercial opportunities.

IgG4 Mediated Conditions

Diseases with clear pathophysiology, support targeting of CD19-expressing B cells with demonstrated clinical proof of concept

LEAD PROGRAM

primary Membranous
Nephropathy (pMN)

Single Organ, Orphan Diseases

Diseases for which B cell depletion has demonstrated clinical proof of concept

LEAD PROGRAM

Immune Thrombocytopenia (ITP)

Complex Systemic Disorders

Multi-organ diseases with a more heterogeneous patient population

LEAD PROGRAM

Systemic Lupus Erythematosus (SLE)

The results from ongoing clinical studies will inform the design of later-stage trials and potential additional expansion into new indications.

Clinical Trial

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