FREIBURG IM BREISGAU, Germany, and PAMPLONA-NOáIN, Spain, February 04, 2025 -- Eleva and 3PBIOVIAN Sign Strategic GMP Manufacturing and Technology Alliance to Boost Capacity for Eleva’s Platform and Pipeline

• 3PBIOVIAN provides production capacity for clinical-grade material for current and future development programs including Eleva’s proprietary Factor H (CPV-104) program, which is expected to enter a first clinical study in C3G patients in H1 2025

• Eleva provides 3PBIOVIAN with access to its proprietary moss-based expression system to build-up manufacturing capacity for future partnered projects

• Both parties will promote Eleva’s moss-based technology platform as a novel solution for the development of complex biologics and collaborate on programs with future partners and clients

Eleva, a pioneer in unlocking difficult-to-produce biologics bbiologics ased on a breakthrough manufacturing platform, and 3PBIOVIAN, a leading contract development and manufacturing organization (CDMO), announced today a strategic alliance to collaborate on the manufacturing of current pipeline programs and potential future programs based on Eleva’s technology platform. Under the terms of the agreement, Eleva secures production capacity at 3PBIOVIAN for the clinical-grade material needed to advance its current pipeline programs into mid- to late-stage clinical development. This covers Factor H (CPV-104), a novel complement modulator currently being developed in C3 Glomerulopathy (C3G) and dry age-related macular degeneration (dry AMD). Additionally, 3PBIOVIAN acquires a non-exclusive license to Eleva’s expression system. As a result of the alliance, Eleva essentially triples its offering of GMP production capacity for programs based on its technology platform.

“With 3PBIOVIAN, we have secured a renowned and high-quality manufacturing partner to support our pipeline expansion strategy. As our current programs advance towards and through clinical studies, forward-looking planning of production capacity is a crucial success factor,” commented Dr. Andreas Schaaf, Ph.D., CSO & Managing Director of Eleva. “At the same time, a range of therapeutic opportunities in our industry could benefit immensely from our moss-based expression system. The relationship with 3PBIOVIAN will allow us to increase the visibility and market penetration of our platform and offers an integrated solution to advance new programs swiftly towards clinical development.”

Dámaso Molero Sánchez, Group CEO at 3PBIOVIAN, added: “We are delighted that Eleva has selected us as a partner for the manufacturing of clinical material for their current pipeline programs, including their novel complement regulator Factor H (CPV-104), which could provide patients with a much-needed new therapeutic option. Access to Eleva’s expression system also supports our commitment to meet the evolving needs of biopharmaceutical developers by continuously expanding our capabilities. Moss-based expression adds a valuable new dimension to our established high-quality offerings in biologics manufacturing.”

Eleva is currently developing Factor H (CPV-104), a recombinant version of human complement Factor H, for complement-related disorders, including CG3 as the first indication, and dry AMD. In C3G, the company expects to enter a Phase 1 clinical study in H1 2025. The clinical material for the first study has already been secured previously. Eleva’s second pipeline program aGal (RPV-001), is being developed in Fabry disease and has delivered promising clinical data in a phase 1b study.

Eleva’s pioneering work in the development of a novel, moss-based expression cell line, has delivered a GMP-ready platform at pre-commercial scale with a current production capacity of up to 2,000 liters. The process is designed as a suspension cell culture suited for standard fermenter equipment. Today’s news supports Eleva’s strategy of building up clinical and commercial-scale manufacturing capacity in collaboration with 3PBIOVIAN for platform-based products across all major pharmaceutical markets, while also attracting a network of commercial partners for de novo discovery programs.

+++ Meet the Eleva team during BIO-Europe Spring in Milan, Italy, March 17-19, 2025,

About Eleva

Eleva is a clinical-stage biopharmaceutical company unlocking difficult-to-produce biologics based on a breakthrough manufacturing platform. The company’s proprietary drug development activities currently focus on complement disorders and enzyme replacement therapies. Factor H (CPV-104), a recombinant version of human complement Factor H, is expected to enter clinical studies in C3 Glomerulopathy (C3G) in H1 2025. The company’s aGal (RPV-001) program to treat Fabry disease has completed a Phase 1b clinical study with promising results. All programs are sourced from Eleva’s transformative moss-based expression system, which allows lab to GMP-scale manufacturing of challenging proteins with previously untapped therapeutic potential. 

About 3PBIOVIAN

3PBIOVIAN is a globally operating Contract Development and Manufacturing Organization (CDMO), delivering end-to-end services for biotech and pharma companies. Their service offerings include protein expression and production platforms based on microbial strains and mammalian cells, plasmid DNA, viral vectors for adenovirus and adeno-associated virus for gene therapy, and cell therapy products. Additionally, they provide fill and finish services for recombinant proteins and viral vectors. The company has manufacturing facilities in Pamplona-Noáin, Spain, and Turku, Finland, efficiently supporting the diverse needs of their clients, covering everything from preclinical and clinical supply to large-scale commercial manufacturing for drug substance and drug product.