KP104, the first bifunctional biologic in complement

Our lead program, KP104 represents a significant breakthrough in complement therapy. It is a potent, first-in-class bifunctional biologic designed to simultaneously and selectively block the alternative and terminal pathways, providing a powerful and synergistic method of targeting validated drivers of complement disease.

Safety Data

Data to date suggests strong safety across SAD and MAD, with no clinically relevant safety findings or signs of immunogenicity.

Enhanced Inhibition of AP and TP

KP104 has been engineered to have an extended half-life and high potency. Its Factor H domain provides proximal complement inhibition at the C3 convertase step of the alternative pathway amplification loop while the anti-C5 antibody moiety provides inhibition of the terminal pathway and also acts as a tissue targeting device to bring Factor H regulatory function to tissues with C5b-9 deposition by virtue of its C5b-binding activity.

Orphan Drug Designation

KP104 was recently granted Orphan Drug Designation by the U.S. FDA for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Preclinical data was presented for the first time at ECMHD in August 2022 and Phase 1 data will be presented at an upcoming conference in November 2022.

Multiple Formulations and Good Manufacturing Data

KP104 has a formulation suitable for both intravenous and subcutaneous administrations. Initial manufacturing experience demonstrates high yield manufacturing and high purity.

mechanism of action

KP104 Targets Multiple Pathways

mechanism of action

KP104 Targets Multiple Pathways

KP104 is the only drug to simultaneously block the upstream Alternative Pathway (Factor H) and downstream Terminal Pathway (C5). With this novel dual-approach mechanism of action, KP104 is uniquely positioned to target complement-mediated diseases where single-target C5 or C3 inhibitors alone are inadequate.

Recently, evidence has emerged to suggest that for certain indications, such as PNH, simultaneous blockade of both proximal and terminal complement pathways may be needed. Click here to read the NEJM paper.

Read more about the PNH example
Targeting multiple areas of unmet need

KP104, Potential to be a Pipeline in a Product

KP104 is entering Phase 2 POC trials across multiple indications with significant unmet need, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), thrombotic microangiopathies secondary to systemic lupus erythematosus (SLE-TMA) and paroxysmal nocturnal hemoglobinuria (PNH). Phase 2 trials will be conducted globally including in the U.S., China, Australia, and South Korea.

Renal Diseases
  • IgAN
  • C3 Glomerulopathy

  • Thrombotic Microangiopathies Secondary to Systemic Lupus Erythematosus (SLE-TMA)
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)

And Many More +
  • Lupus Nephritis
  • ANCA Vasculitis
  • Membranous nephritis (MN)
  • Myasthenia Gravis
  • …and Beyond!