Making hay while the sun shines on cellular therapies, Seattle-based Juno Therapeutics Inc. is raising up to $318.7 million in a public follow-on offering and concurrent private placement with its partner Celgene Corp. Juno shares (NASDAQ:JUNO) rose 8.5 percent on the news, to close at $45.14 on Friday.
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.
Edesa Biotech Inc., a Canadian startup developing dermatology and anorectal therapies, has raised a $7 million series A financing to fund a phase IIb trial of EB-01, a topical secretory phospholipase A2 (sPLA-2) inhibitor therapy it is developing for the treatment of allergic contact dermatitis.
Supernus Pharmaceuticals Inc. shares fell 23.4 percent Tuesday after the company dropped one of two doses of an experimental treatment for impulsive aggression in children with attention deficit hyperactivity disorder (ADHD) that it was evaluating in twin phase III studies.
Swept ahead of schedule by a summer protocol amendment, a positive phase III trial of Xtandi (enzalutamide) in men with early stage castration-resistant prostate cancer (CRPC) is now providing key evidence that could back their inclusion in the drug's label. Long desired by Astellas Pharma Inc. and Pfizer Inc., the partners behind Xtandi, the change could make about 20,000 more men eligible for on-label use of the drug in the U.S. each year alone, bolstering sales and further validating Pfizer's $14.3 billion acquisition of Medivation Inc.
A pivotal trial comparing lefamulin, Nabriva Therapeutics plc's antibiotic for patients with community-acquired bacterial pneumonia (CABP), to the standard-of-care treatment, moxifloxacin, found it noninferior to the well-known quinolone, sparking new confidence in the Sandoz GmbH spinout as it heads from the now completed I.V.-to-oral LEAP 1 study into the all-oral LEAP 2 trial, top-line results of which are expected during spring of 2018.
Neuronal epigenetics specialist Rodin Therapeutics Inc. has completed a $27 million financing that will fund its soon-to-be-chosen lead histone deacetylase 2 (HDAC2) inhibitor through a phase Ib proof-of-concept study in Alzheimer's disease (AD). A multimillion-dollar R&D and option deal it struck with Biogen Inc., however, is dead, terminated by mutual agreement, Rodin's president and CEO, Adam Rosenberg, told BioWorld.
Swept ahead of schedule by a summer protocol amendment, a positive phase III trial of Xtandi in men with early stage CRPC is now providing key evidence that could back their inclusion in the drug's label. Long desired by Astellas Pharma Inc. and Pfizer Inc.
Following the failure of Inotek Pharmaceuticals Corp.'s trabodenoson to move the needle in treating glaucoma, the company has found a new way forward: a proposed merger with New York-based gene therapy startup Rocket Pharmaceuticals Ltd. Led by former Novartis AG cell and gene therapies unit veteran Gaurav Shah, the combined company is developing a pipeline of gene therapies based on lentiviral virus and adeno-associated virus (AAV) platforms, with a focus on treating rare diseases. (See BioWorld, July 11, 2017.)
Hopes that Onxeo SA's doxorubicin-loaded nanoparticle, Livatag, would finish a pivotal trial and be ready for filing as a new treatment for challenging cases of hepatocellular carcinoma were dashed as the drug failed to outperform standard-of-care therapies, such as oxaliplatin, gemcitabine or tyrosine kinase inhibitors. News of the results sent Onxeo shares (PARIS:ONXEO) down more than 50 percent and turned the company's attentions to finding a partner to advance Livatag, as it focuses on other programs in its pipeline.
