News

The US Food and Drug Administration has approved two biosimilar drugs for the treatment of bone-related disorders – the first follow-on products for medicines developed by Amgen Inc. The new biosimilars, Wyost and Jubbonti, have been produced by Sandoz Group AG, a recent spin-out of Novartis. The active ingredient in both medicines, denosumab, is a human monoclonal antibody that binds to the RANKL protein, an activator of osteoclasts. Osteoclasts are cells that are involved in breaking down bone tissue.

Novo Nordisk A/S’s semaglutide (Ozempic), currently approved to reduce the risk of adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease, has achieved another milestone. This was evidence that the drug reduced the risk of kidney disease-related events by 24% in people with type 2 diabetes and chronic kidney disease. The data comes from the Phase 3 FLOW trial, which was stopped early in October 2023 due to efficacy. The headline results from this trial were released on 5 March.

An investigational RNA interference (RNAi) treatment has delivered positive data in a Phase 2 trial of people with mild to moderate uncontrolled hypertension, according to the developers Roche and Alnylam Pharmaceuticals Inc. The two companies have now started another Phase 2 study of the drug, zilebesiran, in people with uncontrolled hypertension at high cardiovascular risk.

A Phase 2b study of a small molecule drug for the treatment of early Alzheimer’s disease failed to meet its primary and key secondary endpoints, the Germany-based developer Vivoryon Therapeutics NV, announced on 4 March. The drug targets an enzyme, glutaminyl cyclase, which is thought to be responsible for the formation of toxic oligomers in the disease. Although the drug showed promising efficacy signals in an earlier Phase 2a trial, it did not show a statistically significant difference in change over time on cognition – the primary endpoint.

Phagenesis Ltd, a UK medical technology company, has raised $42 million from EQT Life Sciences, a private equity group based in Sweden, to commercialise its recently approved device for treating swallowing disorders. The money is being provided by EQT’s Health Economics Fund that invests in late clinical stage health technology companies, or those which are just starting to bring their products to the market. Rudy Dekeyser, former managing director of the Belgian research institute VIB, is head of the fund.

Syncona Ltd, the evergreen investment group, announced on 8 February that its portfolio company Autolus Therapeutics Plc is to collaborate with BioNTech SE to develop new therapies in oncology. The project will aim to advance both companies’ CAR T cell programmes towards commercialisation. These include BioNTech’s cell therapy for solid tumours, BNT211, and Autolus’ two CAR T cell therapy programmes, AUTO1/22, and AUTO6NG, for oncology indications. Under the terms of the agreement, BioNTech has agreed to purchase $200 million of Autolus’ American Depositary Shares in a private placement.

Gilead Sciences Inc is to discontinue studies of magrolimab, a monoclonal antibody targeting CD47 on cancer cells, following evidence that the risks associated with the drug outweigh the benefits. On 7 February the company said it was stopping a clinical programme in haematologic cancers. On 15 February it announced a partial clinical hold on four Phase 2 studies in solid tumours at the request of the US Food and Drug Administration.

A cell therapy for melanoma, the first of its kind, was given an accelerated approval by the US Food and Drug Administration on 16 February for patients whose disease has progressed despite earlier treatment with a checkpoint inhibitor or a personalised cancer therapy. The therapy, Amtagvi (lifileucel), is a tumour infiltrating lymphocyte cell therapy (TIL) which consists of T cells that have been derived from a patient’s own tumour. 

More financial support was announced in late January for the African Medicines Agency (AMA), a regulatory project that will see the 55 countries in the African Union have a dedicated healthcare institution to meet the needs of their combined populations of 1.3 billion people. A treaty formally establishing the agency has been ratified by 27 countries to date. All governments will need to get parliamentary approval of the treaty for the agency to take effect in their countries.

An early clinical-stage radionuclide therapy for neuroendocrine tumours received a ‘breakthrough therapy designation’ from the US Food and Drug Administration on 12 February – the first targeted alpha therapy to do so. The therapy, AlphaMedix, is being developed by RadioMedix Inc of the US and Orano Med of France to treat patients with somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumours. Neuroendocrine tumours mostly occur in the gastrointestinal tract and pancreas, but also can be found in other tissues such as the thymus.