Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD).
In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan.
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
Lion TCR Pte. Ltd. raised $40 million in series B funding that will see the company advance its clinical trial program for its hepatitis B virus (HBV)-specific T-cell receptor (TCR) cell therapy for HBV-related liver cancer.
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
