OSE Immunotherapeutics has announced that the first participant in a Phase I study has been dosed with the company’s CD28-targeting antibody fragment, FR104 (VEL-101). The study will assess the safety, tolerability and pharmacology of single ascending doses of FR104 in healthy volunteers and is designed to inform further Phase II trials in the kidney transplant population. The trial is sponsored and conducted by OSE’s partner, Veloxis Pharmaceuticals, which specialises in transplant medicine. Clinical data from the trial, especially information surrounding subcutaneous injection administration, will add to safety data gathered by OSE in the FIRsT Phase I/II trial in kidney transplant patients, which began in April 2021. We see this as an encouraging development for OSE and for the development of FR104. Our valuation remains unchanged at €319m or €17.5 per share.
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