On May 19, 2026 Matter Bio reported the submission of its first Investigational New Drug (IND) application to the U.S. 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).
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If the IND is cleared by the FDA, the Phase 1/2a study is expected to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of Lm-LLO-TT in patients with PDAC, one of the deadliest and most treatment-resistant solid tumors.
"Submitting our first IND for Lm-LLO-TT is a landmark achievement for Matter Bio and the beginning of our transition into a clinical-stage company," said Chris Bradley, Chief Executive Officer of Matter Bio. "We believe this program represents a differentiated and potentially transformative approach for pancreatic cancer, a disease where patients urgently need better options. Our team has worked with urgency and discipline to bring this therapy to the clinic, and we are excited to take this next step."
Lm-LLO-TT is Matter Bio’s attenuated Listeria monocytogenes-based immunotherapy candidate, designed to stimulate tumor-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.
"Lm-LLO-TT was created to mobilize the immune system in a way that could meaningfully change how we treat difficult solid tumors such as pancreatic cancer," said Claudia Gravekamp, PhD, inventor of Lm-LLO-TT. "The promise of this platform lies in its potential to both engage memory immune mechanisms and target a tumor environment that has remained resistant to many existing approaches. Seeing this program reach IND submission is deeply meaningful and brings us closer to evaluating its potential in patients."
The IND submission represents a major milestone for Matter Bio as the company moves from preclinical development toward clinical evaluation of its lead oncology program. Matter Bio expects to provide additional updates following completion of the FDA’s review of the IND.
(Press release, Matter Bio, MAY 19, 2026, View Source [SID1234665876])