Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.
Onquality Pharmaceuticals LLC has received FDA clearance of its IND application for OQL-036, a potential prophylactic treatment for capecitabine-induced hand-foot syndrome (HFS).
Atsena Therapeutics Inc.’s IND application for ATSN-201 has been cleared by the FDA enabling the company to initiate a phase I/II trial in patients with X-linked retinoschisis (XLRS) caused by pathogenic or likely pathogenic mutations in RS1.
Rnaimmune Inc., a nonwholly owned subsidiary of Sirnaomics Ltd., has received clearance from the FDA for its IND application to conduct a phase I trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
Bridge Biotherapeutics Inc. has received FDA clearance to proceed with a first-in-human study of BBT-207, a potential broad-spectrum fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of non-small-cell lung cancer (NSCLC).
Hanchorbio Inc. has received IND clearance by the FDA to initiate a clinical trial of HCB-101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma (NHL).
Promis Neurosciences Inc. has submitted an IND application to the FDA for PMN-310 for the treatment of Alzheimer’s disease. PMN-310 is a monoclonal antibody designed to be highly selective for toxic oligomers of amyloid-β (Aβ) that are believed to be a major driver of AD, as opposed to monomers or plaque.
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