Eleva is separating its moss-based biologics platform from its clinical-stage Factor H therapy as CPV-104 moves towards further clinical development in complement-related diseases.

Two companies to focus on different development stages

German biotechnology company Eleva is separating its business into two independent companies, with Eleva Biologics focused on its moss-based biologics platform and One04 Therapeutics responsible for developing CPV-104.

Eleva Biologics will focus on partnerships involving the discovery, development and manufacturing of complex biologics using its Bryotechnology platform.

One04 Therapeutics will focus on CPV-104, a recombinant human Factor H therapy being developed initially for C3 glomerulopathy (C3G), a rare kidney disease linked to dysregulation of the complement system.

The separation follows the progression of CPV-104 through Phase 1 development. A separate announcement from One04 Therapeutics said interim results from the study supported continued development, with favourable safety and tolerability findings and early efficacy trends reported in patients with C3G.

The first-in-human study began dosing in 2025 and is evaluating the safety, tolerability and pharmacokinetics of CPV-104 in healthy participants and people with C3G.

Factor H programme moves towards further development

CPV-104 is a recombinant full-length human Factor H protein designed to regulate activation of the complement system.

Factor H controls the alternative complement pathway, helping prevent excessive complement activation. In C3G, abnormal complement regulation can lead to accumulation of complement components in the kidneys and progressive kidney damage.

Eleva is developing CPV-104 initially in C3G and is also investigating the therapy in dry age-related macular degeneration (AMD). The company previously reported European Union orphan drug designation for CPV-104 in C3G.

The therapy is manufactured using Eleva’s moss-based expression technology. The company says this approach allows production of recombinant proteins that can be difficult to manufacture using conventional expression systems.

The platform has been used to produce clinical-grade CPV-104, including material for its clinical programme. Eleva also has a manufacturing alliance with 3PBIOVIAN covering production capacity for CPV-104 and future programmes using its technology.

Eleva retains focus on biologics platform

Under the new structure, Eleva Biologics will pursue partnerships around its moss-based production technology and its ability to develop complex proteins.

The company said its platform is being used to investigate recombinant antibody modalities, multi-domain fusion proteins and other biologics that can present challenges for conventional production systems.

Erich Rajkovic, chief business officer of Eleva, said: “The capability of our moss-based platform to produce highly complex molecules is demonstrated by the achievement of producing a properly folded, fully functional, recombinant Factor H at clinical scale.”

He added: “Many high-value biologics never realize their therapeutic potential because they cannot be expressed with the required quality or scaled efficiently.”

Björn Cochlovius, CEO of Eleva, said: “The successful progression of Phase 1 testing of CPV-104 is a natural transition point for this separation to support the advancement of both businesses.”

The companies will remain under Eleva’s parent company, which will retain shared general and administrative functions while the two businesses develop separate financing strategies and increasingly independent operations.

One04 Therapeutics plans to expand clinical development of CPV-104 beyond C3G, including further work in kidney diseases and dry AMD.

The latest separation therefore marks a shift in focus for the two businesses, with Eleva Biologics seeking external partnerships around its manufacturing and biologics platform while One04 Therapeutics concentrates on advancing a clinical-stage complement therapy.