Obsidian Therapeutics receives FDA regenerative medicine advanced therapy designation for OBX-115 for the treatment of advanced melanoma

Obsidian Therapeutics

3 September 2024 - Obsidian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor therapy. 

OBX-115 is a novel engineered tumour derived autologous T cell immunotherapy (tumor infiltrating lymphocyte cell therapy) armoured with membrane-bound IL15 that is pharmacologically regulated using FDA approved small molecule drug acetazolamide.

Read Obsidian Therapeutics press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Priority review