Human Immunology Biosciences Inc. (Hi-Bio) is moving ahead to late-stage work after disclosing positive phase II data from two trials testing the monoclonal antibody felzartamab for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. CEO Travis Murdoch told BioWorld that his firm is “working through designs for the next study, and planning to engage with regulators,” after which more details will be shared. PMN, he added, has “not been heavily trodden, but increasingly there’s a recognition that there’s an important patient and commercial opportunity” in the indication. Read More
A $10 million pot of seed money has catapulted Ctrl Therapeutics Inc. into existence, enabling it to advance an immunotherapy approach in which tumor cells are extracted from the bloodstream rather than the tumor itself. By targeting circulating tumor-reactive lymphocytes (cTRLs) in the blood, the company’s cell therapy platform – which originated at the University of Toronto – is designed to address the challenges of existing cell therapy technologies. Read More
Acute thrombosis, including heart attack and stroke, is a leading cause of mortality worldwide. Yet only a small fraction of patients can be treated with current therapeutic or surgical interventions. Enter Basking Biosciences Inc., a 2019 startup aimed at developing a short-acting, fast-onset thrombolytic drug alongside a reversal agent for treating acute ischemic stroke. Read More
On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases to get a good reading in one of its two phase III vaccine studies. The northern hemisphere clinical trial of mRNA-1010, a seasonal quadrivalent vaccine, did not meet the statistical threshold because there were not enough sick participants to test to determine an interim efficacy analysis. Read More
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most. Read More
New hires and promotions in the biopharma industry, including: ACM Biolabs, Ascidian, Curevo, Hdax, Immutep, Jasper, Kyowa Kirin, Poseida, RS, Sana, Scholar Rock, Tune. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABVC, Altamira, Durect, Eisai, Evecxia, Horizon, Mabwell, Merck, Molecular Templates, Nuance, Nuvectis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptimmune, Astrazeneca, BMS, Foundation Med., Fulgent Genetics, GSK, Imagine, Lygenesis, Mission, Novartis, One-Two, Panbela, Pharming, Provention, Quince, Sanofi, Sobi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Can-Fite, JW, Merck, Moderna, Promis, Sumitomo. Read More
