Clinical Research

A bispecific T cell engaging antibody developed by Roche for diffuse large B-cell lymphoma (DLBCL) received an accelerated US approval on 16 June, the second authorisation this year for the Swiss multinational in this indication. The drug, Columvi (glofitamab) was authorised by the Food and Drug Administration based on response rate and durability of response in a Phase 1/2 trial. In April the FDA approved Polivy, an antibody drug conjugate from Roche in combination with other drugs, also for DLBCL.

A candidate vaccine designed to protect against chikungunya virus infection has met its primary endpoint in a Phase 3 study paving the way for a regulatory review and possible launch in geographies where the disease is prevalent. The results of the study were published in The Lancet on 12 June 2023. The vaccine, VLA1553, has been developed by Valneva SE of France.

Switzerland-based BC Platforms AG is to strengthen its position as a provider of real world data for clinical research with the acquisition of 4Pharma Ltd, a contract research organisation located in Turku Finland. The acquisition, announced on 1 June, will bring the Finnish company’s research capabilities, which include medical writing and data collection, into BC Platform’s global service offering. The financial terms of the transaction were not disclosed.

Data from a Phase 3 trial of a combination vaccine candidate to prevent meningococcal disease, a bacterial infection that can cause death or permanent disability, were positive, according to the developer GSK Plc. The vaccine candidate showed non-inferiority in primary endpoints for five Neisseria meningitidis serogroups compared with Bexsero and Menveo, two marketed GSK vaccines, which together cover the same serogroups. The five Neisseria meningitidis serogroups account for nearly all invasive meningococcal disease cases in the world.

Gene editing technology has been used by an international team of researchers to create a new therapeutic that targets Escherichia coli in the guts of patients with blood cancers who are at risk of infection. A preclinical study of the new therapy was published in Nature Biotechnology on 4 May. The therapy, SNIPR001, was developed by Denmark-based SNIPR Biome ApS which is currently conducting a Phase 1 trial of the drug in the US. The drug has received a fast track designation from the Food and Drug Administration.

Preclinical data for the small molecule drug vidofludimus calcium has revealed its activity in relation to a neuroprotective transcription factor in addition to its ability to inhibit an enzyme which plays a key role in the metabolism of overactive immune cells and virus-infected cells, Immunic Inc announced on 17 May. The findings have been published in the Journal of Medicinal Chemistry.

Fenebrutinib, a small molecule drug being investigated for multiple sclerosis, was able to reduce brain lesions in people with the disease, the developer Roche announced on 17 May. The results were obtained from a Phase 2 trial of fenebrutinib, a Bruton’s tyrosine kinase inhibitor, which is being studied in adults with relapsing forms of the disease. Data from the study showed that fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared with a placebo, the primary endpoint of the trial.

H. Lundbeck A/S scored two important regulatory goals in April and May, just weeks after closing its books for the first quarter, a period during which it produced its highest three-month revenue figure ever. Revenue was DKK 5 billion (€670 million) for the period, up by 15% from a year earlier.

Eli Lilly and Co reported positive results for its Alzheimer’s disease drug donanemab on 3 May saying that the Phase 3 TRAILBLAZER-ALZ 2 trial met the primary and all secondary endpoints measuring cognitive and functional decline. The company expects to make a regulatory submission to the US Food and Drug Administration by 30 June. Lilly submitted a regulatory application for donanemab to the FDA in January but the agency turned it back citing insufficient data.

Just a year after closing a €60 million Series B financing, Tubulis GmbH of Germany has concluded a licensing agreement with Bristol Myers Squibb Company to develop antibody-drug conjugates (ADC). Announced on 20 April, the deal will give BMS rights to Tubulis’ technology platform to develop ADCs for solid tumours. The number of products to be developed wasn’t disclosed.