The Challenge
Complement Therapeutics, a spin-out from the University of Manchester, was founded with a vision to develop innovative therapeutics for complement-related diseases. Beginning in ophthalmology, the company’s lead investigational gene therapy is being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), a progressive condition and leading cause of blindness globally.
As an early-stage company translating academic innovation into a clinical candidate, Complement Therapeutics faced key challenges common to emerging gene therapy developers, including securing funding, establishing a scalable, regulatory-compliant manufacturing process and defining and executing non-clinical and regulatory strategies.
The Collaboration
In 2020, Complement Therapeutics began its collaboration with the Cell and Gene Therapy Catapult (CGT Catapult) - a long-term partnership that would support its journey from concept into clinical development.
Initially, CGT Catapult provided in-kind support, assessing the technical landscape for the proposed use of an adeno-associated virus (AAV) vector and providing recommendations to the team at the University of Manchester. This resulted in a re-design of the therapeutic vector and a clearer definition of the scientific and commercial opportunity, and led to the successful spinout of Complement Therapeutics and its subsequent raising of €5 million of seed funding.
Building on this foundation, the collaborating organisations worked together towards defining Complement Therapeutics’ non-clinical strategy, laying the groundwork for progression into clinical development. In 2022, Complement Therapeutics were awarded funding from Innovate UK, enabling further collaboration with CGT Catapult to shape its regulatory strategy, and prepare for engagement and submissions to the regulators. This partnership directly supported successful meetings with the FDA (pre-IND) and MHRA (scientific advice), providing critical guidance that helped secure an Innovation Passport under the accelerated Innovative Licensing and Access Pathway (ILAP) and ultimately steer the development pathway of Complement Therapeutics’ lead programme.
Complement Therapeutics successfully raised a substantial €72 million Series A financing round in 2023, enabling the advancement of its lead programme into phase I/II clinical studies and the continued development of complement pathway–modulating therapies for a broader range of diseases.
In 2024, Complement Therapeutics and CGT Catapult extended their collaboration on several multi-partner initiatives, supported by over £2 million in Innovate UK grant funding. These efforts focused on optimising AAV manufacturing processes to enhance efficiency and sustainability, improve product quality, and reduce cost of goods. This long-standing partnership has not only supported Complement Therapeutics in advancing its clinical candidate, but has also enabled CGT Catapult to deliver benefit to the wider advanced therapies sector by applying shared learnings around more efficient and cost-effective manufacturing.
Learn more about these collaborations:
- Touchlight, Cell and Gene Therapy Catapult and Complement Therapeutics to develop innovative manufacturing process for gene therapies
- CGT Catapult, Pharmaron Biologics (UK) Ltd and Complement Therapeutics receive £1.4m grant to develop a perfusion process to improve production of gene therapies
Complement Therapeutics has demonstrated strong commitment to advancing gene therapy by leveraging CGT Catapult’s comprehensive support across all areas of advanced therapies. Most recently, the company benefited from access to state-of-the-art facilities at CGT Catapult’s Skills and Training Laboratories, further strengthening its internal capabilities.
In addition, the success of this enduring partnership demonstrates how CGT Catapult has strengthened and expanded its capabilities to support emerging companies and further enable the advanced therapies industry to develop life-changing medicines that are scalable.
Learn more about how CGT Catapult supports across the ATMP pathway
Where are they now?
Complement Therapeutics has recently achieved a significant milestone, receiving FDA clearance of their Investigational New Drug (IND) application. This approval marks a pivotal step, enabling the company to progress to first-in-human clinical studies.
Evolving from a university spinout to a clinical-stage biotechnology company in approximately four years, Complement Therapeutics exemplifies how focused collaboration, strategic funding, and innovation in manufacturing can accelerate the development of pioneering gene therapies towards the clinic and set a firm path to commercial reality.