AstraZeneca (AZ) and Quell Therapeutics have announced a collaboration agreement focused on developing cell therapies for two autoimmune disease indications, with the deal potentially worth over $2bn.

The partnership will utilise Quell’s T-regulatory (Treg) cell engineering modules, including its Foxp3 phenotype lock, to develop Treg cell therapy candidates for type 1 diabetes and inflammatory bowel disease.

Engineered Treg cell therapies aim to regulate the immune system in a targeted way to prevent over-activation and resultant pathological immune responses.

They have been shown to potentially possess multiple therapeutic effects within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory diseases.

Quell will be responsible for the process development and manufacturing of clinical candidates through to the end of the first-in-human clinical study, at which point AZ will have the option to further develop and commercialise successful candidates.

Under the terms of the agreement, Quell will receive an upfront payment of $85m and will also be eligible to receive over $2bn in future development and commercialisation milestones, plus tiered royalties.

Quell will also have the option to co-develop therapies from the type 1 diabetes programme in the US in exchange for additional milestone payments and increased royalties on net US sales.

Eli Lilly has entered into an agreement to acquire Dice Therapeutics for approximately $2.4bn, signifying a significant boost to its immunology pipeline.

The deal grants Lilly access to the biopharma’s lead candidate, DC-806, an oral small-molecule inhibitor of the pro-inflammatory cytokine interleukin-17 (IL-17) currently in phase 2 development for psoriasis.

Dice said DC-806 had “best-in-class” potential in October last year when it announced positive results from an early-stage trial of the drug, which was associated with a 43.7% reduction in psoriasis area and severity.

The acquisition also includes a second candidate, DC-853, which is being developed as a “fast follower” to DC-806, meaning it should have improved potency and metabolic stability. A top-line readout from an early-stage trial of the IL-17 inhibitor is expected in the second half of this year.

Dice is also developing oral therapeutic candidates targeting the integrin α4ß7 for the treatment of inflammatory bowel disease.

Under the terms of the agreement, Lilly will pay Dice $48 per share in cash, representing a premium of about 40% to the company’s 30-day volume-weighted average trading price.

The transaction is not subject to any financing condition and is expected to close in the third quarter of this year, subject to customary closing conditions.

The US Food and Drug Administration (FDA) has granted fast-track designation to AC Immune SA’s investigational anti-amyloid beta immunotherapy vaccine for Alzheimer’s disease.

The announcement follows the FDA clearance of the company’s investigational new drug (IND) application, allowing for the expansion to the US of the ongoing phase 1b/2 ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

ACI-24.060’s fast-track designation and IND clearance, as well as the expansion of ABATE to include individuals with Down’s syndrome, was supported by initial interim safety and immunogenicity results from the low dose cohort of the trial. Dosing in a second, higher dose cohort began earlier this year.

Those with Down’s syndrome have a third copy of all or part of chromosome 21, which contains the gene that codes for amyloid-precursor protein, and overproduction of this protein is believed to cause the accumulation of anti-amyloid beta plaques – a key hallmark of Alzheimer’s disease.

Given the more predictable onset and progression of symptoms in Down’s syndrome-related Alzheimer’s disease, AC Immune said it believes ABATE’s results will “offer crucial insights into the ability of ACI-24.060 active immunotherapy to modulate neurodegeneration at its earliest stages and offer this population a much-needed therapeutic option”.

The US Food and Drug Administration (FDA) has approved CellTrans’ Lantidra (donislecel) as the first cellular therapy to treat patients with type 1 diabetes.

The authorisation specifically applies to adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education.

Type 1 diabetes requires lifelong care, including the regular administration of insulin.  However, some patients have trouble managing the amount of insulin needed every day, and dosing becomes difficult. These patients may also develop hypoglycaemia unawareness, where they are unable to detect that their blood glucose is dropping and may not have a chance to treat themselves.

Lantidra, which is administered initially as a single infusion, aims to replace the insulin-producing beta cells in the pancreas, reducing the need for patients to take insulin to control their blood sugar levels.

The therapy was evaluated in two single-arm studies in which 30 patients with type 1 diabetes and hypoglycaemic unawareness received one to three infusions.

Overall, 21 patients did not need to take insulin for a year or more, with 11 not needing insulin for one to five years and ten not needing insulin for more than five years.