Immunesensor Therapeutics Inc. has received Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) clearance by Australia’s Therapeutic Goods Administration (TGA) to initiate a phase I study of IMSB-301, a novel, orally available small-molecule cGAS inhibitor that is being developed for the treatment of inflammatory and autoimmune diseases.
Kalm Therapeutics Inc. disclosed a $700,000 oversubscribed closing of its seed round, which will be used to complete regulatory activities outlined in Kalm’s pre-IND meeting with the U.S. FDA, fund personnel and transfer the company’s patch production to a manufacturer.
Insignis Therapeutics Inc.’s sublingual anaphylaxis treatment IN-001 has received Fast Track designation from the FDA. The Fast Track program is designed to expedite the product review and facilitate the development of drugs that treat serious conditions and address unmet medical needs.
China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC.
Shanghai Zedeman Pharmaceutical Technology Co. Ltd. has identified aryl hydrocarbon receptor (AhR) agonists reported to be useful for the treatment of autoimmune disease, cancer, diabetes, eye disorders, viral infections, psoriasis, and inflammatory and neurological disorders, among others.
Epics Therapeutics SA has described N6-adenosine-methyltransferase catalytic subunit (METTL3) inhibitors reported to be useful for the treatment of autoimmune disease, cancer, infections, and neurological and inflammatory disorders.
Precision Biosciences Inc. has announced that its experimental allogeneic T cell therapy azercabtagene zapreleucel (azer-cel) for the treatment of multiple sclerosis (MS) has received IND clearance from the FDA.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with its BCMA-targeting CAR T cell SYS-6020 for systemic lupus erythematosus (lupus) in China.
Scientists from Abbvie Inc. and the Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center have discovered a new allosteric MALT1 inhibitor, ABBV-MALT1, for the treatment of certain types of diffuse large B-cell lymphoma (DLBCL).