The record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. In 2020, 106 new offerings were completed and raised $22.5 billion, more than double 2018's record of $10.7 billion.
Regeneron Pharmaceuticals Inc. posted positive initial results from its ongoing phase III study of its monoclonal antibody cocktail, REGEN-COV (casirivimab and imdevimab), used as a passive vaccine, designed to provide immediate short-term passive immunity to prevent COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient. Eli Lilly and Co. reported upbeat news the same day, as the phase III Blaze-1 trial testing its antibody cocktail met its primary and key secondary endpoints.
Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus Synergy Inc., whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd.
Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
The frenetic and record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. In 2020, 106 new offerings were completed and raised $22.5 billion, which was more than double the previous record of $10.7 billion set in 2018. The race is on for a new record in 2021.
Sekar Kathiresan is building Verve Therapeutics Inc. around the concept of a one-and-done treatment for cardiovascular disease because only half of patients are disciplined enough to take a statin every day. “That’s a huge issue for durable cholesterol lowering after a heart attack,” Verve’s CEO and co-founder told BioWorld.
Arcus Biosciences Inc., in a presentation on the opening day of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), reported a 41% objective response rate across the first four cohorts in its phase I dose-escalation study of AB-680, a small-molecule CD73 inhibitor for treating metastatic pancreatic cancer. The data also showed 88% of patients experienced at least some shrinkage of their lesions.
Nantkwest Inc. and privately held Immunitybio Inc. trotted out positive early interim results from their advanced metastatic pancreatic cancer studies showing median survival rates more than double the historic rates: eight month’s survival compared to only three. “Anything beyond three months has an impact,” Patrick Soon-Shiong, Immunitybio’s CEO and Nantkwest’s executive chairman, told BioWorld, with understatement about one of the toughest to manage indications in medicine.
Newly launched Inzen Therapeutics Inc. is wrestling with cell loss and what information those cells impart as they die. The premise, that cells leave a legacy to living cells, is at the heart of the company as it works to find and develop therapies based on its Thanokine Biology, which the company said could be used for preventing and treating cancer, fibrotic disorders, immune-inflammatory disorders, metabolic disorders and degenerative diseases.