Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.
Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.
CSPC Pharmaceutical Group Ltd. has announced FDA approval of an IND application for JMT-106, a bispecific fusion protein drug, for glypican-3 (GPC3)-positive solid tumors.
Guangzhou Fermion Technology Co. Ltd. has announced IND clearance by China’s National Medical Products Administration (NMPA) for FZ-008-145 to treat pain.
Corbus Pharmaceuticals Holdings Inc. has obtained FDA clearance of its IND application for CRB-601, a TGF-β-blocking monoclonal antibody targeting the integrin αvβ8. Enrollment in a first-in-human phase I study will open in the first half of this year.
Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.
Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.
Quanta Therapeutics Inc. has announced progression of its pipeline of KRAS-directed drug candidates, with the receipt of IND approval from the FDA for QTX-3034.
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