Senti Biosciences Inc. has received clearance of its IND application from the FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome, while sparing healthy bone marrow cells.
Aurinia Pharmaceuticals Inc. has submitted an IND application to the FDA for AUR-200, a potential next-generation therapy for B-cell-mediated autoimmune diseases.
Avstera Therapeutics Corp. has received FDA clearance of its IND application for HDAC6 inhibitor AVS-100. Avstera intends to initiate a phase Ia/b trial in the first half of 2024 to evaluate AVS-100 alone and in combination with pembrolizumab in locally advanced or metastatic solid tumors.
Nrx Pharmaceuticals Inc. has announced FDA clearance of its IND application for the use of NRX-101 (lurasidone hydrochloride/D-cycloserine) for the treatment of complicated urinary tract infections (cUTI).
Immuneering Corp. has obtained FDA clearance of its IND application for IMM-6-415, an oral, twice-daily small molecule in development for the treatment of advanced RAF or RAS mutant solid tumors.
Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-564 for the treatment of solid tumors.
Nextpoint Therapeutics Inc. has received FDA clearance of its IND application for NPX-887, a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1.
Vittoria Biotherapeutics Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial with VIPER-101, a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
Simcere Pharmaceutical Group Ltd.’s subsidiary Simcere Zaiming Pharmaceutical Co. Ltd. has received FDA clearance of an IND application for SIM-0501, an oral small-molecule inhibitor of ubiquitin-specific peptidase 1 (USP1), for advanced solid tumors.
RSS
