By Raffaele Pereno – PhD, MBA
MILAN, Italy – At Bio Europe Spring 2025, Dr. Henrik Luessen, Chief Business Officer at Eleva Biologics, spotlighted the company’s lead therapeutic candidate, CPV-104, a recombinant human Factor H developed using Eleva’s proprietary moss-based manufacturing platform.
A Unique Platform for Complex Biologics
Eleva Biologics has emerged as a leader in plant-based biologics, leveraging Physcomitrella patens, a moss species, as the backbone of its production system. This platform offers several distinct advantages over traditional CHO cell or microbial expression systems:
- Serum-Free, Scalable Production: Moss grows in simple bioreactors with just water, minerals, and light—eliminating the need for animal-derived components and reducing costs.
- Precision Glycoengineering: Moss can be tailored to produce human-compatible or disease-specific glycosylation patterns, improving therapeutic protein stability and efficacy.
- Efficient Folding of Complex Proteins: Moss enables high-fidelity expression of proteins—like Factor H—that are challenging to produce in CHO cells, making it ideal for complex and rare-disease targets.
CPV-104: A First-in-Class Recombinant Factor H
Factor H is a key regulator of the alternative complement pathway. Genetic mutations or autoantibodies can disrupt its function, leading to excessive complement activation and tissue damage. CPV-104 aims to restore balance by replacing defective or missing Factor H.
Eleva’s recombinant Factor H is being developed to treat C3 glomerulopathy (C3G), with additional preclinical programs underway for atypical hemolytic uremic syndrome (aHUS) and dry age-related macular degeneration (dry AMD).
C3G: A Devastating Rare Kidney Disease
C3 glomerulopathy is a progressive kidney disease often diagnosed in young adults. Around 50% of patients progress to kidney failure within a decade, requiring dialysis or transplantation. The condition also severely impacts quality of life, causing fatigue, mobility limitations, and mental health struggles.
At the core of C3G is alternative pathway dysregulation. Unlike other complement pathways triggered by pathogens or immune complexes, the alternative pathway is constantly active at low levels (“tick-over”). In C3G, loss of Factor H function allows uncontrolled C3b deposition, leading to kidney inflammation and damage.
The Complement System: A Delicate Balance
The complement system is a vital part of innate immunity, consisting of over 30 proteins that help eliminate pathogens via:
- Opsonization – Tagging pathogens with C3b for removal
- Inflammation – Recruiting immune cells to infection sites
- Lysis – Destroying pathogens via the membrane attack complex (MAC)
Factor H ensures the system distinguishes self from non-self. When it’s absent or dysfunctional, the body’s own tissues become targets—central to diseases like C3G.
CPV-104 vs. Factor B Inhibitors
Dr. Luessen noted that CPV-104 is expected to enter clinical trials in the first half of 2025. Its development follows the recent FDA approval of Fabhalta™ (iptacopan) from Novartis, a Factor B inhibitor that blocks formation of the alternative pathway’s C3 convertase.
While Fabhalta represents a therapeutic breakthrough, CPV-104 may offer a more physiological approach. Rather than broadly suppressing complement activity, Factor H replacement restores natural regulation—potentially reducing infection risk and directly addressing the root cause in patients with Factor H deficiencies or autoantibodies.
A Promising Outlook
With CPV-104, Eleva Biologics combines therapeutic precision with a scalable, animal-free production platform. As it prepares for clinical trials, Eleva’s moss-based technology holds the potential to transform treatment for patients with complement-driven diseases—many of whom currently face limited or no effective options.
About Eleva Biologics
Eleva is a clinical-stage biopharmaceutical company developing novel therapies and unlocking difficult-to-produce biologics based on a transformative manufacturing platform. The company’s innovative drug development activities currently focus on complement disorders and enzyme replacement therapies, with wider potential across a range of disease areas. For further information go to https://elevabiologics.com.
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