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Cellevolve Bio Inc. announced that the FDA has cleared its IND application for CE-VST01-JC, an allogeneic, off-the-shelf, JC-specific T-cell therapy (JC-VST) targeting JC polyoma virus (JCV), being studied for the treatment of progressive multifocal leukoencephalopathy (PML).
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.
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.
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