Arrowhead Pharmaceuticals Inc. said it voluntarily paused a phase I/II study of its RNAi candidate for treating cystic fibrosis (CF) out of an “abundance of caution” while considering its next steps. “This may delay our pulmonary program a bit, but it’s just part of drug development,” said Christopher Anzalone, Arrowhead’s CEO. The halt was prompted by signals of local lung inflammation found in an ongoing chronic toxicology study in rats.
New top-line data from Kintara Therapeutics Inc.’s phase II study of its lead candidate, VAL-083, in recurrent glioblastoma multiforme were incrementally better than data released in April, and that’s just fine with CEO Saiid Zarrabian. “Normally, in my experience, top-line data usually regresses a little,” Zarrabian told BioWorld. “The fact that it improved could be a reflection of the small size of the study, but it adds a little more interest to top-line data.”
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
A new study from researchers at the Washington University School of Medicine In St. Louis demonstrated evidence of a long-lasting immune response, possibly one that could last for years, from receiving Pfizer Inc.’s mRNA COVID-19 vaccine.
Barely a week after cutting a deal with Beigene Ltd. that included an up-front of $45 million cash, Shoreline Biosciences Inc. and Gilead Sciences Inc.-owned Kite are collaborating to develop allogeneic cell therapies in a deal that could bring Shoreline more than $2.3 billion plus royalties.
Lev Becker spent about six years studying how to release neutrophile elastase from human neutrophils so it could select cancer cell types that need killing and ignore non-cancer cells. That research eventually led to a recent publication in Cell and the launch of Onchilles Pharma Inc.
Iteos Therapeutics Inc. and Glaxosmithkline plc (GSK) are sharing costs for global development of the anti-TIGIT monoclonal antibody EOS-448 and plan to split the U.S. profits in a deal that brings Iteos an up-front payment of $625 million plus up to $1.45 billion in potential milestone payments.
The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported.
Taking its mission as looking at how cells function as opposed to looking at them anatomically, Kojin Therapeutics Inc. is launching with a $60 million series A to accelerate its ferroptosis-, or iron-dependent cell death-, based discovery platform for tackling hard-to-treat diseases, including drug-resistant cancers.
