On June 10, 2026 Matter Bio, a biotechnology company developing next-generation immunotherapies for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for LM-LLO-TT, its attenuated Listeria monocytogenes-based immunotherapy candidate for the treatment of pancreatic ductal adenocarcinoma.
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The FDA clearance allows Matter Bio to proceed with a first-in-human Phase 1/2a clinical trial designed to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of LM-LLO-TT in patients with pancreatic ductal adenocarcinoma.
"This FDA clearance represents a major milestone for Matter Bio and marks our official transition into a clinical-stage company," said Christopher Bradley, CEO of Matter Bio. "Pancreatic ductal adenocarcinoma remains one of the most challenging cancers to treat, and we believe LM-LLO-TT has the potential to activate tumor-directed immune responses in a way that could meaningfully contribute to the next generation of cancer immunotherapy."
LM-LLO-TT is designed to leverage an attenuated Listeria monocytogenes platform to stimulate targeted immune activity against tumor-associated antigens. The upcoming Phase 1/2a study will assess LM-LLO-TT in patients with pancreatic ductal adenocarcinoma, with the goal of establishing an appropriate dose and generating early clinical evidence to support further development.
The IND clearance follows Matter Bio’s previously announced IND submission and reflects continued execution of the Company’s development strategy for LM-LLO-TT.
"This milestone is the result of significant work across our scientific, clinical, regulatory, and manufacturing teams," said Dr. Sam Sharifi, CSO of Matter Bio. "We are grateful to our collaborators and advisors who have helped advance LM-LLO-TT to this important stage, and we look forward to initiating clinical evaluation."
(Press release, Matter Bio, JUN 10, 2026, View Source [SID1234666544])