Biotechnology company Matter Bio announced on Tuesday the submission of its first Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Lm-LLO-TT for a first-in-human Phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC).
If the IND is approved, the Phase 1/2a study is planned to assess the safety, tolerability, dose optimisation, and preliminary anti-tumour activity of Lm-LLO-TT in patients with PDAC.
Lm-LLO-TT is Matter Bio's attenuated Listeria monocytogenes-based immunotherapy candidate, designed to stimulate tumour-directed memory immune responses in difficult-to-treat cancers. The company is advancing the programme in PDAC, where current treatment options remain limited and patient outcomes remain poor.
Submission of the IND represents a milestone for Matter Bio as the company moves from preclinical development toward clinical evaluation of its lead oncology programme.
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