GSK Plc ended 2023 with a pipeline of 71 vaccines and specialty medicines in clinical development and a forecast for sales of more than £38 billion by 2031 – an upgrade from earlier financial projections. Underlying the forecast are plans for the launch of at least 12 new products from 2025. These are vaccines and medicines in development for infectious diseases, HIV, respiratory diseases and oncology.
IMU Biosciences Ltd, a two-year old UK company, has raised £11.5 million from private investors to create a map of the human immune system using artificial intelligence. The goal is be able to monitor the presence of immune disorders early and guide the development of targeted drugs, also known as precision medicines. The Series A financing was announced on 24 January and led by Moulton Ventures Plc. It also included LifeX Ventures and several individuals.
Biogen Inc is to discontinue the development and commercialisation of Aduhelm (aducanumab), its monoclonal antibody treatment for Alzheimer’s disease in order to direct resources towards newer treatment types. Developed with Eisai Co Ltd, Aduhelm was given an accelerated approval by the US Food and Drug Administration on 7 June 2021 on the basis of data showing a reduction of beta-amyloid plaque in patients.
MetrioPharm AG, a Swiss biotech company, has reported positive results from a trial of its small molecule immune modulator in patients hospitalised with Covid-19. The Phase 2a study showed that the drug, MP1032, was effective when administered with a standard of care and delivered lower mortality compared with patients receiving a placebo and standard of care. According to the company, the results showed that MP1032 is comparable to remdesivir (Veklury), an approved antiviral, with additional safety benefits.
BlueRock Therapeutics LP has exercised an option and gained exclusive rights to a cell therapy derived from induced pluripotent stem cells (iPSC) for the treatment of primary photoreceptor diseases. The product, OpCT-001, was developed in collaboration with Fujifilm Cellular Dynamics Inc, a manufacturer of human iPSCs and iPSC-derived cells, and Opsis Therapeutics LLC.
Healthcare professionals are being advised to monitor patients and clinical trial participants who receive treatment for cancer with a chimeric antigen receptor (CAR) T cell therapy for the risk of secondary malignancies. In a commentary in The New England Journal of Medicine on 25 January, Nicole Verdun and Peter Marks write that while secondary cancers from these medicines appear to be relatively rare, they need to be identified. Drs Verdun and Marks are both senior officials at the US Food and Drug Administration.
Sanofi SA is to acquire an experimental biologic for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare disease of the lungs and liver, in a deal valued at up to $2.2 billion. The asset is currently being developed by Inhibrx Inc, a Nasdaq-listed company in the US, which has a pipeline of four main assets. Sanofi will acquire INBRX-101, a recombinant fusion protein which is in a registrational trial for patients with AATD. The deal was announced on 23 January.
A group of European venture funds led by Forbion of the Netherlands has raised €75 million in Series A financing to support the launch of a new biotech company based in Oslo Norway. Calluna Pharma AS will develop antibody therapeutics for the treatment of inflammatory and fibrotic diseases. It has been created from a merger of Oxitope Pharma BV of the Netherlands and Arxx Therapeutics AS of Norway. Besides Forbion, the financing syndicate includes the Norwegian funds Sarsia Management, p53 Invest AS and Investinor AS. The venture finance was announced on 23 January.
A combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has been effective in reducing the risk of disease progression in patients with metastatic colorectal cancer – the first dual immunotherapy regime to show significant benefits as a first-line treatment, according to Bristol Myers Squibb Co. BMS, which developed both drugs, announced the results of the Phase 3 CheckMate-8HW trial on 20 January.
Evotec SE has reaffirmed its financial guidance for 2023 and outlined its ethics policy in a conference call with analysts on 22 January. This follows the announcement on 3 January by Werner Lanthaler, the chief executive, that he would be stepping down from his position for personal reasons. Mario Polywka, a member of Evotec’s supervisory board, has agreed to serve as interim CEO until a new chief executive is appointed.