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.
OSE Immunotherapeutics reports positive Phase 2 ovarian cancer trial results
Whitehawk Therapeutics signs new option agreement for use of CPT113 linker-payload
4basebio secures clinical supply agreement for Phase II immunotherapy trial
Myosin Therapeutics doses first patient in Phase 1/2 study of MT-125 in GBM
ImmunityBio secures US patent portfolio covering ANKTIVA combination therapy through to 2035
CelLBxHealth partners with AdventHealth on cancer monitoring studies
SN BioScience reports first patient dosed in global Phase 1b/2 clinical trial of SNB-101
US FDA approves Datar Cancer Genetics' comprehensive genomic profiling assay for solid tumours
Intensity Therapeutics receives Cancer Treatment Technology Innovator of the Year award
AstraZeneca reports survival gains in Phase III bladder cancer trial
Creatv Bio opens CLIA-certified laboratory in Monmouth Junction, NJ