In a significant development for rare disease therapeutics, biotechnology company Eleva has partnered with contract development and manufacturing organization (CDMO) 3PBIOVIAN to manufacture and scale production of its innovative complement modulator, Factor H (CPV-104).
The manufacturing agreement secures crucial production capacity for Eleva's pipeline programs, particularly focusing on their lead compound targeting C3 Glomerulopathy (C3G), a rare kidney disease, and dry age-related macular degeneration (AMD). Clinical trials for the C3G indication are scheduled to commence in the first half of 2025.
Advanced Manufacturing Platform
At the heart of this partnership is Eleva's proprietary moss-based expression system, which has demonstrated capability to produce GMP-ready material at pre-commercial scale. The platform boasts an impressive production capacity of up to 2,000 liters, positioning it well for commercial manufacturing needs.
Under the terms of the agreement, 3PBIOVIAN has received non-exclusive rights to utilize Eleva's expression system, marking a significant vote of confidence in the technology's potential broader applications in biopharmaceutical manufacturing.
Therapeutic Innovation
Factor H, developed as CPV-104, represents a novel approach to treating complement disorders. The therapy is designed to maintain better functionality of the human body's immune system compared to currently available treatments, potentially offering improved outcomes for patients with complement-related diseases.
Andreas Schaaf, CSO and managing director of Eleva, emphasized the strategic importance of the partnership: "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."
Platform Potential
The collaboration extends beyond immediate manufacturing needs. Schaaf highlighted the broader implications for the biopharmaceutical industry, noting that Eleva's moss-based expression system could benefit the sector as a whole. The partnership with 3PBIOVIAN is expected to enhance the visibility and market penetration of this innovative platform technology.
