Quell Therapeutics Significantly Expands Clinical Manufacturing Capacity for its Engineered Treg Cell Therapies through a Collaboration with the Cell and Gene Therapy Catapult

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

LONDON, Sept. 23, 2021 /PRNewswire/ -- Quell Therapeutics Ltd ("Quell"), the world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, today announced it has entered a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult). 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.

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 world-leading 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 enables emerging 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 Good Manufacturing Practice (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 the required 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, Chief Executive Officer 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."

About Quell Therapeutics

Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aim to harness, direct and optimize their immune suppressive properties to address serious medical conditions driven by the immune system.

The Company is leveraging its pioneering phenotype lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.

Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in neuroinflammatory and autoimmune diseases. www.quell-tx.com.

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult was established as 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. With more than 350 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.

About the European Regional Development Fund

The expansion of the Cell and Gene Therapy Catapult facility in Stevenage has received £3.36m of funding from the England European Regional Development Fund as part of the European Structural and Investment Funds Growth Programme 2014-2020. The Ministry of Housing, Communities and Local Government (and in London the intermediate body Greater London Authority) is the Managing Authority for European Regional Development Fund. Established by the European Union, the European Regional Development Fund helps local areas stimulate their economic development by investing in projects which will support innovation, businesses, create jobs and local community regenerations. For more information visit https://www.gov.uk/european-growth-funding.

About the Industrial Strategy Challenge Fund

The Cell and Gene Therapy Catapult Stevenage project has received £12m of funding from the Industrial Strategy Challenge Fund, part of the government's modern Industrial Strategy. The Industrial Strategy Challenge Fund is a four-year, £1 billion investment in cutting-edge technology designed to create jobs and improve living standards, built on guidance from business and the academic community. Healthcare and Medicine is one of three core areas for investment under the programme.

Contacts:

For Quell Therapeutics:

Media: Mark Swallow, Frazer Hall
MEDiSTRAVA Consulting
+44 207 638 9571
[email protected]

Investors: Christina Tartaglia
Stern Investor Relations, Inc.
+1 212 362 1200
[email protected]

For CGT Catapult:

FTI Consulting:
Michael Trace, +44 (0)203 319 5674, [email protected]
George Kendrick, +44 (0)203 727 1411, [email protected]