Bintrafusp alfa – the novel immunotherapy at the centre of a major alliance between GlaxoSmithKline (GSK) and Merck KGaA – has failed in a late-stage trial in difficult-to-treat cancers.

GSK and Merck entered the partnership in 2019 to jointly develop and commercialise bintrafusp alfa – previously known as M7824. At the time, the deal was said to be worth $4.2bn (€3.7 billion or £3.2bn) to the Darmstadt-headquartered Merck.

That includes an upfront payment paid by GSK to Merck of €300m – although the €500m earmarked for a milestone payment triggered by data from the lung cancer programme will now be lost.

The phase 3 INTR@PID Lung 037 study evaluated bintrafusp alfa as a first-line treatment for patients with stage IV non-small cell lung cancer (NSCLC) that have high expression of PD-L1.

In a statement, Merck said that the study’s Independent Data Monitoring Committee (IDMC) recommended that the trial should be discontinued, as it is ‘unlikely’ to meet the co-primary endpoint of progression-free survival.

“We remain committed to further evaluation of bintrafusp alfa, and this data from INTR@PID Lung 037 will provide important insights that may be applied to future studies,” said Danny Bar-Zohar, global head of development for the healthcare business of Merck.

A new research institute at the University of Oxford has been established to fight against antimicrobial resistance (AMR).

The Ineos Oxford Institute (IOI) will be based between two sites in Oxford, linking the university’s Department of Chemistry and the Department of Zoology.

It will build on Oxford’s expertise and legacy in the field of AMR and antibiotic research and drug discovery – scientists at the university made progress in making concentrated penicillin after it was discovered by Alexander Fleming in the early 20th century.

The new institute has initially received funding from Ineos, a British chemical company, totalling £100m, which will enable research into the development of new drugs tackling AMR for animals and humans.

The institute will also aim to spread awareness of the responsible use of existing antibiotic medications. The IOI plans to partner with other global leaders in AMR research to achieve this goal.

Although the progression of antibacterial resistance is a natural process, it is being rapidly exacerbated by the overuse and misuse of antibiotics in humans and also in agriculture processes, Oxford University said in a statement.

The IOI will contribute to research on the type and extent of drug-resistant microbes globally, to gain a greater understanding of so-called ‘superbugs’.

“This is a wonderfully generous gift for which we are very grateful. It is another example of a powerful partnership between public and private institutions to address global problems,” said Louise Richardson, vice chancellor of the University of Oxford.

Merck & Co’s appeal to restore a verdict against Gilead for infringing on a patent relating to a hepatitis C virus (HCV) treatment has been rejected by the US Supreme Court.

In 2016, a US federal court sided with Merck in a patent claim which stipulated that Gilead’s sofosbuvir – which features in its blockbuster Sovaldi and Harvoni HCV drugs – infringed on a patent held by Merck subsidiary Idenix Pharmaceuticals.

This patent covers a particular family of compounds that have the same basic chemical structure with properties that are effective against HCV.

The court awarded $2.54bn in damages to Merck as a result – this, however, was overturned by the US Court of Appeals for Federal Circuit in 2019, after the court determined that the patent was invalid.

The patent dispute dates back to August 2013, when Merck first contacted Gilead requesting that the company pay royalties on sofosbuvir and obtain a licence to patent.
Gilead also filed a lawsuit seeking a declaratory judgment that the Merck patent is invalid and not infringed on the basis that it covers “compounds which do not include, but may relate to, sofosbuvir”.

Gilead alleged in the lawsuit that Merck had amended its patent application in an attempt to extend its coverage to include sofosbuvir.
“Idenix discovered that a single type of modified ribonucleoside inhibits the hepatitis C virus,” said Gilead.

“Yet it sought a patent covering a vast genus of billions of untested and largely unmade compounds that might later prove to have similar effect,” the company added.

Merck, when filing for its appeal to the Supreme Court, said that the 2019 ruling undermined biotechnology breakthroughs.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Amarin’s fish oil-derived drug icosapent ethyl for the prevention of cardiovascular events in high-risk patients.

The CHMP has adopted a positive opinion for marketing authorisation of the drug under the brand name Vazkepa in the EU.

The committee has recommended use of the drug in adult patients already receiving statin treatment, and who have elevated triglycerides.

Patients must also have established cardiovascular disease or diabetes and at least one other cardiovascular risk factor.

In December 2019, the US Food and Drug Administration (FDA) approved the drug with the brand name Vascepa, also to reduce the risk of cardiovascular events in high-risk patients.

At that time, Vascepa became the first FDA-approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy.

Similar to the FDA approval, the CHMP recommendation is supported by results from the REDUCE-IT trial, which evaluated Amarin’s drug in over 8,000 statin-treated adults with elevated cardiovascular risk.

In this trial, it achieved a reduction of 25% in major adverse cardiovascular events (MACE) and a 20% reduction in deaths.

Following the CHMP recommendation, the European Commission will now review the application, with a decision expected within 67 days of the positive opinion.