Boehringer Ingelheim and Immunitas Therapeutics have announced a global
licensing agreement for a preclinical antibody programme being developed for chronic inflammatory and autoimmune diseases.

The programme is designed to selectively target cells that play a central
role in driving chronic inflammation, with the goal of achieving sustained disease
control for patients who do not respond adequately to current therapies.

In an agreement worth 407.5m euros, Boehringer Ingelheim will obtain
worldwide rights to develop, manufacture and commercialise the antibody programme. Immunitas Therapeutics will receive an upfront payment, milestone
payments and tiered royalties.

Chronic inflammatory and autoimmune diseases affect millions of people
worldwide and can significantly impact quality of life. While current therapies
have improved outcomes for some patients, many experience limited or
diminishing benefit over time.

Unlike therapies that block individual inflammatory signals, the licensed
Immunitas antibody programme is designed to target pathogenic cells
localised at the sites of inflammation. By targeting this subset of pathogenic cells,
the approach has the potential to provide deeper and more durable benefit across a range of inflammatory conditions.

Sanofi’s Tzield (teplizumab) has received expanded approved from the US FDA, allowing it to be used for children aged one year and older with stage 2 type 1 diabetes (T1D) to delay progression to stage 3 disease.

The decision extends the therapy’s previous approval, which covered patients
aged eight years and above, and was granted under a priority review. It is supported by one-year data from the phase 4 PETITET1D study, which assessed safety and pharmacokinetics in younger children.

The PETITE-T1D study is an open-label, single-arm phase 4 trial involving 23
participants under the age of eight with stage 2 T1D.

Stage 2 T1D is characterised by the presence of two or more diabetes-related
autoantibodies alongside dysglycaemia, reflecting ongoing autoimmune destruction of beta cells. Progression to stage 3 marks the onset of clinical disease, requiring lifelong insulin therapy.

Type 1 diabetes is a progressive autoimmune condition in which immunemediated
destruction of pancreatic beta cells leads to loss of insulin production. Early
intervention to delay disease progression is seen as a potential way to reduce the burden of disease management, particularly in very
young children.

The US FDA has granted Rare Paediatric Disease (RPD) designation for Satellite Bio’s SB-101 to treat urea cycle disorders (UCDs).

Satellite Bio is a biotechnology company developing off-the-shelf liver therapies designed to restore liver function in patients with severe liver diseases.

UCDs are devastating, life-threatening conditions with high infant mortality and significant risk of neurological injury, with no curative treatment available in the first weeks of life.

UCDs primarily affect individuals aged from birth to 18 years of age, with serious or life-threatening manifestations such as neurocognitive deficits, behavioural impairment, encephalopathy, coma, seizures, organ failure and mortality.

The current standard of care for UCDs remains inadequate, with mortality rates exceeding 25%, cognitive impairment affecting half of the patients and no curative treatment available in the first weeks of life.

Satellite Bio’s lead programme, SB-101, is a first-in-class, off-the-shelf liver therapy being developed as a treatment for infants with severe early onset UCD. The company plans to initiate a phase 1/2 clinical trial of SB-101 in 2026. Satellite Bio’s pipeline also includes additional drug candidates designed to improve liver function.