AstraZeneca to collaborate on Type 1 diabetes and IBD therapies with Quell Therapeutics in deal worth potential $2bn
AstraZeneca has agreed a collaboration potentially worth more than $2bn to Quell Therapeutics, focused on therapies for Type 1 diabetes and inflammatory bowel disease.
The Cambridge-headquartered biopharmaceutical company will pay $85million upfront in a predominantly cash payment and equity investment in London-based Quell, which specialises in proprietary multi-modular T-regulatory cell engineering.
Mene Pangalos, executive vice president, biopharmaceuticals R&D at AstraZeneca, said: “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 to stop or slow disease progression and ultimately accelerate the delivery of transformative care to patients with chronic autoimmune conditions.”
Under the terms of the deal, Quell’s toolbox of Treg cell engineering modules, including its innovative Foxp3 Phenotype Lock, will be utilised to develop autologous multi-modular Treg cell therapy candidates for major autoimmune disease indications.
Quell CEO Iain McGill said: “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.
“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.”
AstraZeneca will have the option for the further development and commercialisation of successful clinical candidates in Type I diabetes and IBD. Quell will be eligible to receive more than $2billion in milestones, if successful, plus tiered royalties.
Quell also 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 programme with AstraZeneca in the United States in exchange for additional milestone payments and increased royalties on US net sales.
AstraZeneca is, however, discontinuing its brazikumab inflammatory bowel disease (IBD) development programme. The anti-IL-23 monoclonal antibody was being investigated for the treatment of Crohn’s disease and ulcerative colitis, but AstraZeneca said a review of the development timeline and the evolving competitive landscape prompted the decision. It said: “The timeline was impacted by delays that could not be mitigated following global events.”
Meanwhile, the company has reported a raft of results this month:
- Results from the ALPHA Phase III trial showed Danicopan as an add-on to Ultomiris or Soliris improved haemoglobin levels and maintained disease control in patients with the rare and severe blood disorder paroxysmal nocturnal haemoglobinuria (PNH) who were experiencing signs or symptoms of clinically significant extravascular haemolysis.
- Nirsevimab has been unanimously recommended by the FDA advisory committee in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants during or entering their first RSV season. If approved, nirsevimab would be the first preventive option specifically designed to protect the broad infant population in their first RSV season.
- Datopotamab deruxtecan combinations showed encouraging tumour responses in patients with advanced non-small cell lung cancer in the TROPION-Lung02 Phase Ib trial.
- Tagrisso achieved unprecedented survival in early-stage EGFR-mutated lung cancer, with 88 per cent of patients alive at five years in ADAURA Phase III trial.
- Imfinzi plus chemotherapy significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Phase III trial.
- Lynparza plus abiraterone has been approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer
AstraZeneca also confirmed that it is to proceed with regulatory filings to convert the approval for Andexxa (andexanet alfa) from conditional to full in the US and EU. It comes after a Phase IV trial was stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care.
Dr Pangalos said: “Millions of people worldwide depend on FXa inhibitors to prevent harmful blood clots from forming, but these agents also carry a small but significant risk of increasing the likelihood that an acute major bleed could occur. We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required.”
