A new biotech company was launched in Scotland, UK, on 18 April with the goal of treating complex diseases by stabilising certain proteins in the cell. The company, Outrun Therapeutics Ltd, went public following the receipt of $10 million in seed funding. The investors are M Ventures, the corporate venture capital arm of Merck KGaA of Germany, and MP Healthcare Venture Management of Boston, US.
Faron Pharmaceuticals Ltd has appointed new leadership as the company prepares to advance clinical development of bexmarilimab, its wholly-owned immunotherapy for both haematological and solid tumours. The company’s founder and chief executive officer, Markku Jalkanen, is to retire and be replaced by his son, Juho Jalkanen, currently the chief operating officer. The new CEO will take up his position on 1 May.
Pathios Therapeutics Ltd of the UK has secured financial support from Bristol Myers Squibb Co as part of a Series B venture round that will advance its small molecule drug candidate for cancer into the clinic. The first close of the B round raised $25 million and will support development of PTT-4256, a small molecule inhibitor of a G protein-coupled receptor called GPR65. In addition to BMS, funding was secured from the existing investors Canaan Partners and Brandon Capital Partners.
A new blood test for Alzheimer’s disease has received a ‘breakthrough device designation’ from the US Food and Drug Administration for its promise as a way of identifying the disease early, and distinguishing it from other neurodegenerative disorders. The device, Elecsys pTau217 is an in vitro immunoassay intended for the quantitative determination of the protein phospho-tau (217P) in human plasma.
The European Medicines Agency has issued a positive opinion for Fabhalta (iptacopan), a monotherapy for a rare genetic blood disorder which has shown superior activity to the standard of care. The disorder is paroxysmal nocturnal haemoglobinuria (PNH) which causes the premature breakdown of red blood cells in the body leading to fatigue, shortness of breath and often requiring blood cell transfusions.
A group of medicines approved to treat type 2 diabetes and obesity, which include semaglutide, have passed a safety review by the European Medicines Agency. The review was triggered by reports linking use of the drugs, which are glucagon-like peptide-1 receptor agonists (GLP-1), to suicidal and self-harm thoughts and behaviour. On 12 April, the agency’s pharmacovigilance risk assessment committee (PRAC) said an investigation could not establish a causal association between the medicines and the health risks.
Genentech Inc and its Swiss parent, Roche, have ended a cell therapy partnership with Adaptimmune Therapeutics Plc which was focused on developing allogeneic T cell therapies for cancer. The reason for the termination, announced on 10 April, wasn’t given. However it comes at a time when other large companies are making staff redundant or divesting early-stage biotech projects. On 11 April, Syncona, the investment group, announced plans to sell a cell therapy portfolio company to Century Therapeutics Inc. This was to prioritise capital allocation on later-stage assets.
Sumagen Co Ltd, a Korean-Canadian company developing an experimental vaccine for HIV-1, is to start manufacturing the product for use in clinical trials under a new partnership with Naobios SAS of France. Naobios is a contract development and manufacturing organisation. Announced on 15 April, the companies did not disclose the financial terms. There are currently no approved vaccines for HIV, a disease that is estimated to affect 39 million people worldwide. The Sumagen product is based on recombinant genetically modified virus technology.
An experimental gene therapy for the rare neurological disorder, Canavan disease, has been given a regenerative medicine advanced therapy (RMAT) designation by the US Food and Drug Administration. RMAT designation is a regulatory incentive awarded by the agency to cell or gene therapy products which show promise for treating or reversing the course of a serious disease.
Two small European companies have announced a collaboration under which they plan to repurpose an approved medicine for chemotherapy induced nausea to be used in patients with lung cancer. The business deal was announced on 9 April and involves PlusVitech of Spain and Nanoform Finland Plc of Finland. It focuses on progressing a small Phase 2 study in patients with non-small cell lung cancer refractory to standard treatment. The current formulation of the drug involves the administration of potentially dozens of capsules per day to patients who are frail and may have dysphagia.