Gilead Sciences and Dragonfly Therapeutics have announced a new partnership focused on advancing Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for cancer and inflammatory diseases.

A clinical-stage biopharmaceutical company, Dragonfly focuses its research capabilities on discovering, developing and commercialising therapies that implement its Tri-specific NK Engager (TriNKET) platform.

Gilead will make an upfront payment of $300m to Dragonfly, with an option for further royalties of up to 20% on global net sales.

NK cell engagers are part of a mechanism that has the ability to tackle a wide range of cancers. This includes potential for activity in checkpoint resistant and refractory tumours, alongside other disease areas like inflammation.

Gilead will gain an exclusive, global licence for DF7001, part of a 5T4-targeting investigational immunotherapy programme. DF7001 is a TriNKET created to activate and control NK and cytotoxic T-cell killing against aggressive cancer cells.

DF7001 could destroy 5T4+ expressing cells, including tumour cells, cancer-associated fibroblasts and cancer stem cells.

In addition to this, the deal also allows further options for Gilead – after certain preclinical activities are finalised – to license exclusive, global rights to develop and commercialise additional NK cell engager programmes using the Dragonfly TriNKET platform.

A new study funded by AstraZeneca has revealed insights into chronic obstructive pulmonary disease (COPD) exacerbations (often referred to as ‘flare-ups’).

The EXACOS-UK study (EXAcerbations of COPD and their OutcomeS) showed that an increased frequency and severity of flare-ups can increase the risk of future incidences and death in primary care COPD patients.

The observational study involved 340,515 COPD patients in the UK and concluded that even the occurrence of one moderate flare-up increased the likelihood of future episodes, underscoring the fact that every flare-up matters.

COPD is a progressive disease and over 70% of people living with the condition can experience at least one moderate or severe flare-up within three years of diagnosis.

As the second largest cause of emergency hospital admissions in the UK, COPD has recorded admission rates higher than most other European countries. This places a significant overall burden on the NHS, with a cost to the healthcare system of £1.9bn a year.

COPD is the fifth most common cause of death in the UK, causing nearly 30,000 deaths every year in England alone.

It has been reported that one-third of patients (33.3%) are not reviewed by a respiratory team within 24 hours of hospital admission, while 38% remain under-treated after being discharged from hospital.

Following regulatory blocks and rejections late last year, Biogen has decided to withdraw its application for its Alzheimer’s drug Aduhelm (aducanumab) in Europe.

The company made the decision to pull its application after discussions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) highlighted that the data provided thus far would not be enough to support a positive opinion on the marketing authorisation of Aduhelm by the regulator.

The EMA had explained that, despite Aduhelm reducing amyloid beta in the brain, the connection between this effect and significant clinical improvement has not been verified.

In December 2021, the EMA raised concerns surrounding the safety of Aduhelm, stating that: ‘The studies did not show that the medicine was sufficiently safe as images from brain scans of some patients showed abnormalities (amyloid-related imaging abnormalities) suggestive of swelling or bleeding in the brain, which could potentially cause harm. Furthermore, it is not clear that the abnormalities can be properly managed in clinical practice.’

The EMA had also said Biogen’s data on the drug’s affect on cognition is ‘conflicted’ and, in response to two identical studies carried out on the treatment, the EMA said the results ‘did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease’.

A pooled analysis of Sanofi’s Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD) has shown that certain organ clinical responses have correlated with clinically meaningful changes in patient-reported outcomes (PROs).

The condition is a complication that can often occur following allogeneic stem cell transplantation, resulting in both significant morbidity and mortality among patients. In cGVHD, transplanted immune cells typically attack the patient’s cells, leading to inflammation and fibrosis in a number of tissues.

Results from the ROCKstar and KD025-208 studies showed particularly significant changes for the skin, mouth, eyes, upper gastrointestinal area and lungs – clearly showing the potential to increase the quality of life for many thousands of cGVHD patients worldwide.

Following the studies, the data also supports the use of PROs for response assessment in cGVHD clinical trials and patient care to help capture individual perspectives on disease activity.

There are approximately 14,000 patients living with cGVHD in the US.

Rezurock is the first and, currently, only approved therapy inhibiting rho-associated coiled-coil kinase 2 (ROCK2). The therapy is approved in the US for the treatment of adult and paediatric cGVHD patients aged 12 years and older.