Matter Bio has submitted its first Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Lm-LLO-TT, the company’s lead therapeutic candidate, for a first-in-human phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC).
If the IND is cleared by the FDA, the phase 1/2a study is expected to evaluate the safety, tolerability, dose optimisation and preliminary anti-tumour activity of Lm-LLO-TT in patients with PDAC, one of the deadliest and most treatment-resistant solid tumours.
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 program in PDAC, where current treatment options remain limited and patient outcomes remain poor.
The IND submission represents a major milestone for Matter Bio as the company moves from preclinical development toward clinical evaluation of its lead oncology programme. Matter Bio expects to provide additional updates following completion of the FDA’s review of the IND.
