LTZ Doses First Participant in Phase 1/1b Trial of LTZ-232 for mCRC and Other Solid Tumors

First-in-human trial evaluates LTZ’s second asset, a first-in-class bispecific myeloid engager targeting EpCAM, a tumor marker highly expressed in a wide range of cancers

REDWOOD CITY, Calif.--(BUSINESS WIRE)--LTZ Therapeutics (LTZ), a clinical-stage, immunotherapy-focused biotechnology company, today announced that the first participant has been dosed in a Phase 1/1b, multicenter clinical study evaluating LTZ-232 in patients with metastatic colorectal cancer (mCRC) and other solid tumors—leveraging its Universal Myeloid Cell Engager (U-MCE™) Platform. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of LTZ-232.

Building on the clinical progress of LTZ-301, already in clinical development for hematologic malignancies, the clinical strategy for LTZ-232 initially prioritizes mCRC—a setting where consistent epithelial cell adhesion molecule (EpCAM) expression meets a myeloid-rich, immunologically "cold" Tumor Microenvironment (TME)—while retaining flexibility to explore activity in other solid tumors.

"Dosing the first patient in our Phase 1 study of LTZ-232 marks an important milestone in the transition from pre-clinical promise to clinical investigation in patients with metastatic CRC," said Robert Ilaria Jr., M.D., senior vice president of clinical development of LTZ Therapeutics. “We look forward to working with our talented academic investigative teams to study this innovative EpCAM-targeted myeloid engager in cancer patients with significant unmet need and exploring how this novel approach could bring meaningful anti-tumor activity in patients with difficult-to-treat tumors."

Colorectal cancer is the third most common cause of cancer and the second leading cause of cancer-related deaths worldwide. Despite increasing survival rates, mCRC remains a devastating disease with a five-year survival rate of approximately 14%, underscoring the urgent need for new approaches.

"Initiating this first-in-human study of LTZ-232 marks an exciting milestone as our first clinical trial targeting solid tumors," said Robert Li, Ph.D., founder and chief executive officer of LTZ. "Dosing our first patient allows us to evaluate the therapeutic potential of our U-MCE™ platform beyond hematologic malignancies—expanding our clinical footprint and generating key data for our innovative myeloid engager approach."

About LTZ-232

LTZ-232 is a first-in-class bispecific antibody designed to bind EpCAM and activate tumor-associated macrophages (TAMs) to phagocytose and eliminate tumor cells. Preclinical studies demonstrated potent pharmacology across in vitro and in vivo models. LTZ-232 transitions the company's pipeline strategy into solid tumor indications, with an initial focus on mCRC.

More information about the trial is available at ClinicalTrials.gov (NCT Number: 07878988).

About LTZ's Scientific Approach

LTZ's approach focuses on the fusion of reverse translational science, with a deep understanding of TME biology—especially myeloid biology. Macrophages are one of the most prevalent immune cell populations in the TME of many hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells offers significant therapeutic potential for patients. LTZ is developing its own U-MCE™ Platform to broadly enhance the phagocytic function of monocytes and macrophages to foster anti-tumor immunity. Additionally, LTZ is exploring the potential therapeutic benefit of its platform for other non-oncology diseases.

About LTZ

LTZ Therapeutics is a clinical-stage, immunotherapy-focused biotechnology company pursuing the development of novel therapies, with the company's Universal Myeloid Cell Engager (U-MCE™) Platform, to improve clinical outcomes in patients with oncology and autoimmune diseases. With headquarters in Redwood City, California and additional operations in Shenzhen, China, LTZ is dedicated to developing myeloid engager immunotherapies for broad disease indications. For more information, please visit https://www.ltztherapeutics.com/.