Welcome to the latest edition of our weekly EuroBiotech Report. Eight months after AbbVie’s ($ABBV) decision to drop filgotinib intensified speculation that testicular toxicity could be a banana skin for Galapagos’ JAK1 inhibitor, the Belgian biotech and new partner Gilead revealed they will include a 200-mg daily dose in their upcoming Phase III trial. The decision, which follows talks with the FDA, ends concerns that the link to testicular toxicity could detrimentally affect the design of the study. Circassia reported Phase III trial design news of its own. The British biopharma kicked off a pivotal trial of its grass allergy immunotherapy, in which enrollment will be staggered so early data can support statistical sizing decisions. As the grass allergy season winds down, Bavarian Nordic will be ramping up its trial plans. The Danish vaccine developer posted Phase I data on its respiratory syncytial virus candidate this week, positioning it to prepare to start a larger study later this year. Iceni Pharmaceuticals’ trial plans are less concrete. The company, which opened its doors this week, is repurposing a Merck Serono castoff as a multiple myeloma combo drug with a view to going into the clinic next year. In Israel, three biotechs that missed the IPO boom are waiting, filings at the ready, for the window to reopen. And more. Nick Taylor
1. Galapagos, Gilead include high dose in PhIII RA trial following talk with FDA
Galapagos ($GLPG) and Gilead ($GILD) have confirmed that their upcoming Phase III rheumatoid arthritis trial will give 200-mg doses of JAK1 inhibitor filgotinib, putting to bed concerns that a link to testicular toxicity would force the partners to limit the amount of the drug administered in the study.
2. Circassia kicks off adaptive-design PhIII grass allergy field trial
Circassia (LON:CIR) has initiated a Phase III trial of its grass allergy immunotherapy. The trial is set to enroll approximately 1,500 patients in a stepwise fashion, an approach Circassia thinks will enable it to use data from the first 400 participants to inform a decision about the overall size of the study.
3. Bavarian Nordic RSV vaccine clears early clinical test
Bavarian Nordic (CPH:BAVA) has posted top-line data from a Phase I trial of its respiratory syncytial virus (RSV) vaccine. The early-phase data, which show the vaccine is safe and well tolerated, clear the path for Bavarian Nordic to advance the candidate into a larger study later this year and escalate its preparations for a planned pediatric program.
4. Iceni sets out to turn Serono castoff into multiple myeloma combo drug
Back in 2013, a Phase III failure in glioblastoma patients prompted Merck Serono to add cilengitide to its growing pile of discarded assets. That wasn’t the end of the story, though. The following year, researchers writing in The Lancet Oncology asked “does cilengitide deserve another chance?” Now a startup has set out to answer that question--and has enlisted the support of the Serono R&D chief who axed the drug.
5. Israeli biotechs wait in the wings for opening of IPO window
A trio of Israeli biotechs are on the cusp of publicly filing to list on Nasdaq. The unnamed biotechs have reportedly completed the initial filings for public offerings expected to raise up to $130 million (€116 million) each--but are holding off on going live until demand picks up.