In August 2020, Johnson & Johnson paid $6.5 billion cash to acquire Momenta Pharmaceuticals Inc. That strengthened J&J’s immune-mediated disease portfolio and grew its interest in autoantibody-driven disease therapies by bringing nipocalimab into the fold. Now the investment is paying off with top-line results of phase II and III studies that hit their primary endpoints using the fully human glycosylated monoclonal antibody targeting the human neonatal Fc receptor. The studies were in treating generalized myasthenia gravis and in Sjögren’s disease.
A company focused on regulating immune response through nanoparticle technology, Cour Pharmaceuticals Development Co. Inc. has raised $105 million in a series A round to move its lead autoimmune disease products into phase IIa trials.
Kyverna Therapeutics Inc. disclosed a filing to raise up to $100 million in an IPO, becoming the sixth firm to announce plans for a U.S. listing in the new year, offering tentative hope that the public markets might prove more welcoming to biopharma firms after a lackluster 2023.
Toleranzia AB has completed a pivotal toxicology study designed to determine the potential toxicity of TOL-2, a tolerance-inducing recombinant protein being developed for the treatment of myasthenia gravis, when given intravenously for 10 days.
There are several pan-PIM kinase inhibitors in development for cancer indications, but startup Mysthera Therapeutics AG hopes to become the first biotech company to develop them in the autoimmune diseases space, having secured $3.5 million in seed capital from founding investor Forty51 Ventures.
Gro Biosciences Inc. has presented successful proof-of-concept results in two preclinical programs for autoimmune disease and immunogenicity. The company’s genomically recoded organism (GRO) platform enables precise placement of non-standard amino acids (NSAAs) within a protein.
Toleranzia AB has begun a regulatory GLP-toxicology study of TOL-2, being developed for myasthenia gravis. Animals will receive daily doses of TOL-2 on multiple days to determine the safety and tolerability of TOL-2.
Astellas Pharma Inc. has divulged substituted quinolone derivates acting as acetylcholine receptor cluster inducers reported to be useful for the treatment of neuromuscular disorders.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.