- Eleva Biologics will seek strategic partnerships for development and manufacturing of first-in-class and previously inaccessible biologics discovered with the Bryotechnology platform
- One04 Therapeutics will focus on progressing its wholly owned, first-in-class human complement Factor H therapy, CPV-104, into advanced clinical development
- Separation of the two companies enables capital structures tailored to their distinct strategies and potentiates focused investments and growth acceleration
Freiburg im Breisgau, Germany, September 15, 2026 – eleva GmbH, a pioneer in discovering and developing previously inaccessible biologics, announced today the separation of its businesses into two stand-alone companies: Eleva Biologics GmbH & Co. KG, which will pursue discovery and development partnerships for complex biologics based on its breakthrough moss-based Bryotechnology platform; and One04 Therapeutics GmbH & Co. KG, which will advance its first-in-class human Factor H product-candidate, CPV-104, into late-stage clinical development.
Eleva Biologics will pursue a partnership-led business model using its moss-based Bryotechnology biologics platform. The Bryotechnology platform has been proven capable of discovery, optimization and scalable GMP manufacturing of biological candidates that other technologies could not produce. Eleva Biologics will focus on discovering and developing first-in-class candidates, many of which are scientifically well-validated but have defied attempts at industrial drug development using other technologies. Initial areas of focus include recombinant antibody modalities, multi-domain fusion proteins and other complex biologics.
One04 Therapeutics separately announced today its development plans for CPV-104, its first-in-class recombinant, full-length human Factor H therapy. Factor H is a well-validated key complement control protein that has long resisted drug development because it cannot be manufactured at scale using other GMP production platforms, such as CHO or yeast. CPV-104 is now the only Factor H therapeutic candidate in the clinic and one of two clinical-stage biologics to have been discovered, optimized, and GMP-manufactured at scale using the Bryotechnology platform.
“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,” commented Björn Cochlovius, Ph.D., Chief Executive Officer of eleva GmbH. “Successful production of fully functional Factor H at clinical scale demonstrated the broader capabilities of our Bryotechnology moss-based expression platform. Many additional promising programs remain constrained by expression, product quality, or scale up challenges. Eleva Biologics’ mission is to help partners overcome these barriers.”
“As CPV-104 has matured into a clinical asset with distinct development and financing needs, it will benefit from the capital structure of a company focused on clinical development and supported by new investors looking for a promising opportunity driven by therapeutic-candidate development.”
Bryotechnology is a breakthrough moss-based expression system that allows the development of biologics with highly differentiated, competitive product profiles that are difficult or impossible to achieve with other production systems. The platform preserves the correct folding and assembly of highly complex proteins including multi-domain fusions and complex blood proteins. Additionally, the moss-based system offers precise control over glycosylation and ensures homogeneous protein production.
“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,” said Erich Rajkovic, Ph.D., MBA, Chief Business Officer of eleva GmbH. “Many high-value biologics never realize their therapeutic potential because they cannot be expressed with the required quality or scaled efficiently. We want to work with biotech and pharma partners to unlock these programs focusing on recombinant antibody modalities and other complex fusion proteins.”
Both Eleva Biologics and One04 Therapeutics are owned by eleva GmbH. The parent company will house shared general and administrative functions, enabling both companies to focus on efficiently executing their respective operations with separate financing strategies and increasingly independent capital structures.
ABOUT ELEVA BIOLOGICS
Eleva Biologics is a strategic partner for the discovery and development of highly complex biologics using Bryotechnology. Underpinned by more than 25 years of process engineering, Bryotechnology is a proprietary moss-based platform that unlocks the production of protein therapeutics that are otherwise difficult or impossible to manufacture, while achieving controllable, human-like glycosylation. The platform enables manufacturing of complex molecules – including recombinant antibody modalities, multi-domain fusions, and proteins with complex folding structures – and integrates seamlessly into standard infrastructure. The GMP-validated Bryotechnology platform has produced two moss-derived candidates that have advanced into clinical development in Europe following authorization by the relevant national authorities.
MEDIA CONTACTS
Fabienne Zeitter
Director Corporate Communications
pr@elevabiologics.com
Phone: +49 761 470 99 0
Valency Communications
Mario Brkulj
mbrkulj@valencycomms.eu
Phone: +49 160 9352 9951
INVESTOR CONTACT
| Cohesion Bureau Giovanni Ca’ Zorzi giovanni.cazorzi@cohesionbureau.com Phone: +33 7 84 67 07 27 |
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