Guangzhou Zhiyi Biotechnology Co. Ltd. has received IND approval from the FDA to conduct a phase I study in the U.S. with SK-10 for the treatment of chemotherapy-induced diarrhea.
China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
Nkgen Biotech Inc. has received IND clearance from the FDA for a phase I study of its cryopreserved off-the-shelf allogeneic blood-derived natural killer (NK) cell therapy SNK-02, to evaluate safety and tolerability in participants with pathologically confirmed solid tumors refractory to standard-of-care therapy.
Biomea Fusion Inc. has received IND clearance from the FDA to begin a phase I/Ib trial of BMF-219, a selective, covalent menin inhibitor in patients with unresectable, locally advanced, or metastatic non-small-cell lung cancer (NSCLC), colorectal cancer, or pancreatic ductal adenocarcinoma with an activating KRAS mutation.
Decibel Therapeutics Inc. has received clearance from the FDA for its IND application to initiate a phase I/II trial of DB-OTO in pediatric patients, potentially in infants younger than 2 years of age.
Lyell Immunopharma Inc. has received FDA clearance for its IND application to initiate a phase I trial for LYL-845, an investigational tumor-infiltrating lymphocyte (TIL) therapy enhanced with Lyell's Epi-R technology for patients with relapsed and/or refractory metastatic or locally advanced melanoma and other select solid tumors.
Transcenta Holding Ltd. has received IND clearance from the FDA for TST-004, its best-in-class, humanized monoclonal antibody targeting mannose-binding protein-associated serine protease 2 (MASP2), for IgA nephropathy (IgAN).
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