Josep Bassaganya-Riera, president and CEO of Landos Biopharma Inc., told BioWorld that the firm's lead compound, BT-11, in mouse models is "acting as a double-barrel shotgun" against inflammatory bowel disease (IBD), in both Crohn's disease and ulcerative colitis. Read More
By delivering the gene for myelin oligodendrocyte glycoprotein (MOG), one of the proteins that is a frequent target of autoimmune attack in multiple sclerosis (MS), to the liver, researchers have been able to induce systemic immune tolerance. Depending on the timing of treatment, the approach could prevent or reverse the symptoms of even late-stage experimental autoimmune encephalitis (EAE), the mouse equivalent of MS. Read More
It's a double whammy for cardiovascular drug developers, according to a new study from the Tufts Center for the Study of Drug Development. It's taking longer to get a cardiovascular drug through the clinic and onto market. And more drugs are failing along the way. Read More
Treos Bio Ltd., a London-based company developing precision peptide cancer vaccines coupled with companion diagnostics, has enlisted Pharmaceutical Product Development LLC to manage a phase I trial of PolyPEPI-1018, its lead vaccine for colorectal cancer. Once an investigational new drug application the company is filing is accepted, the trial is expected to start by late January 2018. Read More
Flx Bio Inc., of South San Francisco, selected FLX-475 as its first immuno-oncology clinical candidate for the treatment of cancer. FLX-475 is described as an oral, small-molecule antagonist of CCR4, a receptor protein that plays a role in the recruitment and accumulation of regulatory T cells in the tumor environment. The company expects to enter the clinic with FLX-475 late this year. Read More
Juno Therapeutics Inc., of Seattle, said it launched a proposed follow-on public offering of $225 million of shares of its common stock. In addition, it expects to grant the underwriters a 30-day option to purchase up to an additional $33.75 million of shares of its common stock. Juno intends to use the net proceeds for general corporate purposes and working capital. The number of shares and share price have not yet been disclosed. The company's stock (NASDAQ:JUNO) closed Thursday at $41.62, down $3.59. Read More
Audentes Therapeutics Inc., of San Francisco, said it started dosing patients in ASPIRO, a phase I/II trial of gene therapy candidate AT-123 for the treatment of X-linked myotubular myopathy (XLMTM), a rare monogenic disease characterized by extreme muscle weakness, respiratory failure and early death, with an estimated 50 percent mortality rate by 18 months of age. Read More
The FDA will hold a public workshop Oct. 27 at its White Oak campus in Silver Spring, Md., to address challenges in evaluating products to treat pediatric heart failure. The discussion will include endpoints, study populations, statistical methods, alternative trial designs, extrapolation of adult efficacy data and the use of registry data, according to a notice published in Thursday's Federal Register. Pre-registration is required. Read More
