Bridgebio Pharma Inc. has obtained FDA clearance for its IND application for BBO-8520, a first-in-class orally bioavailable and potent small-molecule direct inhibitor of KRAS G12C (ON) state. The company expects to begin enrolling patients with KRAS G12C mutant non-small-cell lung cancer (NSCLC) in the first half of this year.
Obi Pharma Inc. has received FDA clearance for its IND application to conduct a phase I/II study of OBI-992, a novel antibody-drug conjugate (ADC) cancer therapy targeting TROP2. The trial will open shortly and aims to enroll patients with advanced solid tumors, including non-small-cell lung cancer, small-cell lung cancer and gastric cancer, although several other cancers are also potential targets.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. has received FDA clearance of its IND application for a phase I trial in the U.S. of ABP-745, an anti-inflammatory oral small-molecule drug, for the treatment of acute gout.
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
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).
RSS
