DUBLIN – Philogen SpA raised €62 million (US$70 million) in new equity investment to fund its internal pipeline of "immunocytokine" therapies and to bolster its cGMP production facilities in advance of a potential first product approval and commercial rollout.
DUBLIN – Opdivo (nivolumab) is now approved in 13 distinct cancer indications spread across eight different types of cancer, but glioblastoma multiforme (GBM) is looking unlikely to become an addition to that list, as Bristol-Myers Squibb Co. reported Tuesday that the PD-1 inhibitor failed to demonstrate a survival benefit in the phase III Checkmate-498 study in 550 newly diagnosed GBM patients. Participants had the difficult-to-treat O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated form of the condition.
DUBLIN – Pfizer Inc. is acquiring rare disease firm Therachon AG for $340 million up front and could pay up to $470 million more in development and commercial milestones linked to the progress of Therachon's achondroplasia therapy, TA-46.
DUBLIN – Inhaled drug delivery specialist Vectura Group plc could be adding at least $89.7 million to its coffers after a U.S. jury found that its partner, Glaxosmithkline plc, infringed a Vectura patent in three of its Ellipta-branded products for respiratory disease.
DUBLIN – Promethera Biosciences SA raised €39.7 million (US$44.4 million) in a series D funding round to progress clinical development of its lead cell therapy, Hepastem, in acute-on-chronic liver failure (ACLF) and nonalcoholic steatohepatitis (NASH), as well as to fund scale-up of its manufacturing capabilities and preclinical development of earlier-stage programs.
DUBLIN – Try as they might, Genkyotex SA's management team found it impossible to shift investor perceptions that a phase II trial of GKT-831 in primary biliary cholangitis (PBC) was a bust.
DUBLIN – With the clock ticking on the April 30 PDUFA date for its Contepo (fosfomycin) NDA, Nabriva Therapeutics plc disclosed late Tuesday that the FDA had slapped a complete response letter (CRL) on the file, citing manufacturing deficiencies at one of its contract manufacturers. The Dublin-based antibiotic developer stressed that the agency was not seeking any additional clinical data and had not raised any new safety concerns about fosfomycin, but investors were less than impressed with the inevitable delay to a U.S. launch of the drug, which is in development for treating complicated urinary tract infection (cUTI). Shares in Nabriva (NASDAQ:NBRV) plunged by as much as 42.5% during premarket trading Wednesday before closing down 27.4% at $2.17.
DUBLIN – Polyprox Therapeutics Ltd. is the latest contender to enter the promising but increasingly crowded space of harnessing the proteasome for therapeutic effect. The company, a newly launched spinout from the University of Cambridge, is based on more than a decade of research conducted by its founder and chief scientific officer, Laura Itzhaki, who is professor of structural pharmacology at Cambridge and an expert on protein structure, protein folding, protein-protein interactions and protein engineering.
DUBLIN – Carisma Therapeutics Inc., plans to kickstart a new era in immuno-oncology shortly by testing the first cell therapy to employ macrophages that express a chimeric antigen receptor (CAR). Its lead program, CT-0508, comprises patients' own macrophages engineered to express HER2. It is being readied for patients with HER2-expressing cancers, such as breast, ovarian, lung, gastroesophageal and salivary-gland cancers.
DUBLIN – Kiadis Pharma NV is adding a natural killer cell (NKC) platform for improving the safety and efficacy of hematopoietic stem cell transplant (HSCT) to its existing T-cell therapy focused on the same goal by acquiring Cytosen Therapeutics Inc., in a stock-based transaction valued at just €19.4 million (US$21.9 million) initially, but which could be worth up to €77.5 million in total.
