Company News

Semaglutide reduces risk of kidney disease progression

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.

Positive data for RNAi therapeutic for hypertension

Country
Switzerland

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.

Vivoryon Alzheimer’s study fails

Country
Germany

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 raises finance

Country
United Kingdom

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.

BioNTech and Autolus collaborate

Country
United Kingdom

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 discontinues magrolimab studies

Country
United States

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.

Amtagvi approved by FDA

Country
United States

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. 

Breakthrough designation for radiotherapy

Country
United States

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.

New drug for eosinophilic esophagitis

Country
Japan

The US Food and Drug Administration has approved a new drug for the treatment of eosinophilic esophagitis (EoE), a chronic, immune-mediated inflammatory disease that can cause difficulty swallowing and affect individuals of any age. The drug, Eohilia, is an oral suspension of budesonide which was developed by Takeda Pharmaceutical Co Ltd and shown to be effective in two trials of adult and paediatric patients. The drug was compared with a placebo and administered for a period of 12 weeks. The first study enrolled patients 11 to 56 years of age and the second, 11 to 42 years of age.

Alys launches with capital

Country
United States

Alys Pharmaceuticals Inc, a new company with a preclinical pipeline of candidate drugs for immune-related disorders, was launched on 12 February with $100 million of capital. The company was co-founded by the venture capital group Medicxi and a group of six scientists specialising in immuno-dermatology. The scientific founders are based at institutions in the US, Germany and France and include Craig Mello, professor at the UMass Chan Medical School, US, and winner of a Nobel Prize in 2006 for the discovery of RNA interference.