FDA clearance enables initiation of first-in-human Phase 1/2a clinical trial evaluating LM-LLO-TT, Matter Bio's attenuated Listeria monocytogenes-based immunotherapy candidate.

/PRNewswire/ -- Matter Bio, a biotechnology company developing next-generation immunotherapies for difficult-to-treat cancers, today announced 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.

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."

About Matter Bio

Matter Bio is a biotechnology company focused on developing next-generation immunotherapies for difficult-to-treat cancers. The Company is advancing LM-LLO-TT, an attenuated Listeria monocytogenes-based immunotherapy candidate, into clinical development for pancreatic ductal adenocarcinoma. LM-LLO-TT is designed to stimulate tumor-directed immune responses in difficult-to-treat cancers, including pancreatic ductal adenocarcinoma. www.matter.bio

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Matter Bio's development plans, the initiation and design of clinical trials, the potential therapeutic benefits of LM-LLO-TT, and the Company's expectations regarding clinical development. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. LM-LLO-TT is investigational and has not been approved by the FDA or any other regulatory authority. Matter Bio undertakes no obligation to update any forward-looking statements except as required by law.

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SOURCE Matter Bio