Human Immunology Biosciences Inc. (HI-Bio) unveiled positive phase II data from two trials testing felzartamab, a monoclonal antibody for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. Felzartamab is designed to deplete CD38-positive plasma cells, which are believed to drive PMN by way of producing anti-PLA2R autoantibodies. The drug succeeded in both studies, called M-Place and Newplace, and privately held, South San Francisco-based Hi-Bio plans to push felzartamab into late-stage research.

Newco news: CTRL Therapeutics launches with $10M in seed funding

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. “It allows very high-throughput profiling and sorting of really complicated cell mixtures, and it allows you to find really rare cells,” Shana Kelley, founder and chief technology officer of CTRL Therapeutics told BioWorld.

Newco news: Fast-acting and reversible, Basking seeks to expand options in ischemic stroke

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. In February, the company reported results at the American Heart Association International Stroke Conference from a phase I study in healthy volunteers showing that BB-031, a thrombolytic agent targeting von Willebrand factor (vWF), was safe and tolerable following a single administration. Results also showed dose-dependent vWF binding and changes in platelet function.

Moderna needs more sick people for its phase III flu study

On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases for 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 weren’t enough sick participants to test for an interim efficacy analysis. The good news for Moderna came from the study’s preliminary immunogenicity analysis, showing the vaccine produced titers consistent with superiority against influenza A strains H1N1 and H3N2 while demonstrating non-inferiority against influenza B strains B/Victoria and B/Yamagata. The vaccine was compared to an unnamed competitor. Moderna’s stock (NASDAQ:MRNA) was getting modestly knocked around at midday as shares were trading 3.5% downward at about $154 each.

WHO pushes for more access to COVID-19 antivirals

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 the current voluntary licensing arrangements. The World Health Organization (WHO) today called 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. At the same time, the WHO is encouraging countries not covered by the agreements to use the full flexibilities under the Trade-Related Aspects of Intellectual Property Rights Agreement, including compulsory licensing, to get access to the drugs.

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