IND submission marks Matter Bio's transition toward clinical stage and advances its lead Listeria-based immunotherapy into one of oncology's highest-need indications
SAN FRANCISCO, May 19, 2026 /PRNewswire/ -- Matter Bio today announced 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).
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.
About Matter Bio
Matter Bio is a biotechnology company developing precision genomic technologies and novel therapeutics to better detect, prevent, and treat disease. The company combines advanced tools for measuring DNA damage and genotoxicity with a pipeline of differentiated oncology programs aimed at addressing major unmet needs in cancer. By integrating genomic measurement, translational biology, and drug development, Matter Bio is building a platform to generate clinically meaningful insights and advance new medicines for patients. www.matter.bio
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements regarding the submission, review, and potential clearance of Matter Bio's IND application; the planned initiation, design, timing, and conduct of the company's first-in-human Phase 1/2a clinical trial; and the potential therapeutic benefits of Lm-LLO-TT. These forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including risks related to regulatory review, clinical development, manufacturing, financing, and other factors. Matter Bio undertakes no obligation to update these statements except as required by law.
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