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.
Data presented to the American Society of Clinical Oncology and taken from Hookipa Pharma Inc.’s ongoing phase I/II study for treating advanced human papillomavirus 16-positive (HPV16+) cancers underwhelmed investors as the stock (NASDAQ:HOOK) sagged 19.25% on June 8.
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia.
A day before its June 5 PDUFA date and three months after its original PDUFA, Ryplazim (plasminogen, human-tvmh), from Liminal Biosciences Inc., won FDA approval for treating plasminogen deficiency type 1 hypoplasminogenemia, becoming the first approved therapy for the rare genetic disorder.
Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the metastatic castration-resistant prostate cancer therapy may move on to a dose expansion.
Protalix Biotherapeutics Inc. saw shares dip after releasing initial top-line data from an interim analysis of the phase III Balance clinical trial of pegunigalsidase alfa (PRX-102) to treat Fabry disease. The 24-month, randomized, double-blind, active control study is evaluating the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme). Two of the study’s 78 patients dropped out because of treatment emergent adverse events and one left because of a related adverse event.