Quell Therapeutics, AstraZeneca Partner on Engineered Treg Cell Therapies

Quell Therapeutics Ltd, a leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced that it has entered into a collaboration, exclusive option and license agreement with AstraZeneca to develop, manufacture and commercialize autologous, engineered Treg cell therapies for two autoimmune disease indications.

“We are extremely pleased to have AstraZeneca on board as our first major partner. This collaboration builds on our pioneering work to develop exquisitely engineered, multi-modular Treg cell therapies for immune disorders and provides excellent validation for the technologies and capabilities we have established,” said Iain McGill, Chief Executive Officer of Quell Therapeutics. “We are proud and incredibly excited to partner our leading science with the deep experience of AstraZeneca to accelerate the application of our Treg cell therapy platform in major autoimmune disease, where we believe there is a broad opportunity to reset immune tolerance and drive durable responses for patients.”

“This is a very exciting collaboration with Quell as we look to expand our next-generation therapeutic toolbox and explore the untapped potential with Treg cell therapies in autoimmune indications. This is aligned with our strategy to target underlying disease drivers, stop or slow disease progression and ultimately accelerate the delivery of transformative care to patients with chronic autoimmune conditions,” added Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.

Under the terms of the agreement, Quell’s proprietary toolbox of Treg cell engineering modules, including its Foxp3 Phenotype Lock, will be leveraged to develop autologous multi-modular Treg cell therapy candidates for Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD). AstraZeneca will have the option to further develop and commercialize successful candidates, with Quell responsible for the process development and manufacturing of clinical candidates through to the end of the first-in-human clinical study.

Quell will receive $85 million upfront from AstraZeneca, which comprises a predominant cash payment and an equity investment. Quell is also eligible to receive over $2 billion for further development and commercialization milestones, if successful, plus tiered royalties. In addition, Quell retains an option, which can be exercised either after approval of an Investigational New Drug (IND) application or at the end of the Phase I/II clinical study, to co-develop Treg cell therapies from the T1D program with AstraZeneca in the United States in exchange for additional milestone payments and increased royalties on US net sales.

Quell retains full ownership of its lead Treg cell therapy candidate QEL-001, which is designed to prevent organ rejection and eliminate the need for lifelong immunosuppression in liver transplant patients and is expected to enter first-in-human trials during 2023, as well as its preclinical program in neuroinflammation.