Quell collaborates with CGT Catapult to expand clinical manufacturing capacity for its Treg cell therapies

LondonTuesday, September 28, 2021, 13:30 Hrs  [IST]

Quell Therapeutics Ltd (Quell), the world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has entered a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult), an independent centre of excellence to advance the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and full-scale commercialisation.

The collaboration will expand Quell’s clinical manufacturing capabilities and capacity in one of the recently opened specialist large-scale manufacturing modules at CGT Catapult’s manufacturing innovation centre in Stevenage, UK. This will add a second GMP facility to Quell’s manufacturing operations and allow the Company to efficiently develop and scale the production of its novel multi-modular engineered Treg cell therapies for clinical trials.

Collaboration will facilitate an expanded manufacturing footprint to enable clinical supply of Quell’s pipeline, including QEL-001 in liver transplantation and pipeline programmes in neuroinflammation and autoimmunity.

Quell is currently preparing for the first ever clinical trial of a multi-modular engineered Treg cell therapy with its lead candidate QEL-001, which is designed to prevent organ rejection in liver transplant patients. Quell remains on track to begin the Phase 1/2 “LIBERATE” trial with QEL-001 in the first quarter of 2022. The LIBERATE study will be the first Treg based therapy in transplantation aiming to free patients from all systemic immune suppression.

“In the two years since we launched Quell in 2019, a key part of our strategy has been to build a worldleading manufacturing capability for our engineered Treg product candidates that includes both expert talent and dedicated GMP infrastructure,” said Iain McGill, chief executive officer of Quell Therapeutics. “Our agreement with CGT Catapult is an important strategic step that gives us the flexibility to scale our production capacity, which is crucial to the success of our business both near term, as we prepare for our first clinical trial with QEL-001, and longer term, as we advance our pipeline of novel engineered Treg cell therapies in neuroinflammatory and autoimmune diseases.”

“The Stevenage CGT Catapult Manufacturing Innovation Centre is a proven model that enablesemerging cell and gene therapy companies to further develop their own GMP manufacturing capability at one of the world's premier centres for the development of advanced therapies. I am very excited about this collaboration, which forms a key pillar of our process development, manufacturing and supply strategy,” added Bernd Schmidt, VP product delivery at Quell Therapeutics.

The CGT Catapult was established to bridge the gap between scientific research and full-scale commercialisation to ensure life-changing therapies can reach patients throughout the world. They create powerful collaborations to overcome challenges to the advancement of the sector. The Stevenage Manufacturing Innovation Centre allows companies developing cell and gene therapies to develop their manufacturing processes at scale to GMP standards. The centre, underpinned by a unique collaborative model provides support and expertise from CGT Catapult experts across scientific research, manufacturing, supply, and regulation, to provide therequired capabilities for manufacture at high throughput in a GMP environment. As well as the manufacturing development suites, collaborators work together with CGT Catapult on the development of raw materials supply, quality control testing, cryostorage, logistics, track and trace, and integration into the wider supply chain.

“We are delighted to welcome Quell Therapeutics as the latest pioneering company to collaborate at the CGT Catapult Stevenage,” added Matthew Durdy, CEO at the CGT Catapult.“Quell is a ground-breaking company with leading technology which is progressing engineered Treg cell therapies into the clinic. We are pleased to be able to provide them with the capabilities and collaboration they require to execute their ambitious growth plans.”