News

Mendus AB of Sweden announced on 19 June that it has received a certificate from the European Medicines Agency confirming that the manufacturing preparations and preclinical data for its lead dendritic cell vaccine candidate meet the current regulatory standard. The EMA’s advanced therapy medicinal product certificates may be issued to cell and gene therapy developers at the start of product development to verify quality controls. They are not required for a future regulatory submission.

Syncona Ltd, an evergreen investment group, has confirmed its target for growth over the next 10 years while reporting a decline in the value of its net assets for the 12 months ended 31 March. The UK-based group ended the year with net assets of £1,254.7 million, compared with £1,309.8 million the previous year. Gains were reported from currency movements and from Beacon Therapeutics, a recently launched gene therapy company targeting retinal diseases. However these were offset by a decline in the value of the company’s listed life science holdings.

Eli Lilly and Co has signed a collaboration agreement with Verve Therapeutics Inc,  a clinical stage US genetic medicines company, to develop a product that can treat atherosclerotic cardiovascular disease. This is a disorder arising from a thickening of the arteries, restricting the flow of blood to organs and tissues. An increase in a specific type of lipoprotein can cause the disease. The amount of this protein in individuals is congenital.

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.

Novartis is to pay $3.2 billion upfront to acquire Chinook Therapeutics Inc of Seattle, Washington, US, in a bid to strengthen its renal portfolio with two Phase 3 assets for immunoglobulin A nephropathy (IgAN), a rare, progressive kidney disease. The transaction, which has been approved by the boards of both companies, is expected to close in the second half of 2023. It will take the form of a merger of Chinook into a newly formed Novartis subsidiary.

Syncona Ltd, the UK investment group, has launched its third gene therapy company directed against retinal diseases, including an inherited monogenic disorder that leads to progressive vision loss in males. The launch of Beacon Therapeutics Holdings Ltd was announced on 12 June and follows the UK group’s acquisition and restructuring of Applied Genetic Technologies Corp (AGTC) of the US. Beacon’s assets include a late-stage programme from AGTC in X-linked retinitis pigmentosa, the inherited monogenic disorder, and two proprietary pre-clinical assets identified by Syncona.

ITM Isotope Technologies Munich SE (ITM) has secured €255 million from an investor syndicate led by Temasek of Singapore to advance its pipeline of radiopharmaceuticals for the treatment of cancer. The round, which was also supported by BlackRock Alternatives and the Qatar Investment Authority, will help advance the company’s lead product for neuroendocrine tumours and expand capacity for the production of targeted radionuclide therapies. These are a type of radiation therapy in which a radioactive chemical is linked to a cell-targeting molecule such as a peptide or small molecule.

Quell Therapeutics Ltd has secured its first major partnership for the development of its regulatory T cell technology for the treatment of autoimmune diseases. An agreement with AstraZeneca Plc, announced on 9 June, will bring the two parties together to research and develop potential therapies for Type 1 diabetes and inflammatory bowel disease. AstraZeneca is to make an $85 million upfront payment to Quell comprising cash and equity. If the collaboration is successful, with the commercialistion of new products, milestone payments could exceed $2 billion.

An advisory committee that reviews drug applications for the US Food and Drug Administration has concluded that the Alzheimer’s disease treatment Leqembi (lecanemab) has shown clinical benefit for patients and should be approved. The Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend full approval on 9 June. A decision by the FDA is expected on 6 July.