The first clinical data from an FDA-approved trial of a CAR T-cell therapy in the treatment of multiple sclerosis (MS) show the cells cause complete B-cell depletion, leading on to a reset of the immune system that is accompanied by an improvement in symptoms.
Septerna Inc.’s stock plunged as much as 68% throughout the day Feb. 18 on news that the company was stopping a phase I trial of SEP-786 in healthy volunteers following two severe events of elevated unconjugated bilirubin in the highest dose cohort of the multiple ascending-dose portion of the study.
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
In autoimmune diseases such as inflammatory bowel disease (IBD), the function of regulatory CD8 T cells (CD8 Treg) is compromised, in part due to the expression of inhibitory KIR receptors (KIR2DL1/2/3) and insufficient inducible T-cell co-stimulator (ICOS) signaling. Mozart Therapeutics Inc. has discovered MTX-201, a new bispecific antibody targeting inhibitory KIR and ICOS that are co-expressed by CD8 Tregs.
Stimulating the body’s immune defenses against a tumor can reduce or eliminate it. However, in cancer immunotherapy, when immune checkpoint inhibitors unleash the immune system, severe autoimmunity can result. A hematological technique, extracorporeal photopheresis (ECP), could offer a solution. It reduces the therapy-induced inflammation without altering antitumor immunity. According to scientists at the Universities of Basel and Freiburg, the key lies in adiponectin, a hormone produced by fatty tissue.
Neumora Therapeutics Inc. has patented NMDA receptor positive allosteric modulators reported to be useful for the treatment of autoimmune disease, infections, neurological and psychiatric disorders.
Ensoma Inc.’s lead program, EN-374, has been granted orphan drug and rare pediatric disease designations by the FDA for the treatment of X-linked chronic granulomatous disease. Ensoma anticipates filing an IND application for EN-374 in the first half of this year.
Lycia Therapeutics Inc. has reported progress in its immunology pipeline that comprises lysosomal targeting chimera (LYTAC)-based protein degradation therapies. The company is advancing its two lead programs toward the clinic: LCA-0061, a Catalytac degrader that catalytically degrades IgE, and LCA-0321, a Lytac degrader designed to specifically bind and rapidly deplete anti-thyroid-stimulating hormone receptor (TSHR) autoantibodies.
Researchers in from Nanjing Drum Tower Hospital have presented data from a study that investigated the role of immunoglobulin superfamily member 6 (IGSF6) microglia during ischemic stroke.
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6017, an mRNA vaccine to prevent herpes zoster infections.
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