LTZ Therapeutics Announces FDA Clearance of IND Application for LTZ-232 to Treat Advanced Metastatic Colorectal Cancer and Other Solid Tumors

REDWOOD CITY, Calif.--(BUSINESS WIRE)--LTZ Therapeutics, a clinical-stage, immunotherapy-focused biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate LTZ-232 to treat patients with advanced metastatic colorectal cancer (mCRC) and other solid tumors.

LTZ-232 is the second asset in the company’s platform to enter clinical trials, leveraging its Universal Myeloid Cell Engager (U-MCE^TM) Platform to treat pan solid tumor indications that are epithelial cell adhesion molecule positive (EpCAM+). Building on the clinical progress of LTZ-301, already in clinical development for hematologic malignancies, the advancement of LTZ-232 reflects the company’s strategic expansion into broad solid tumors. LTZ expects to initiate its Phase 1, open-label, multicenter study for LTZ-232 in Q4 2026.

“Advancing LTZ-232 into the clinic represents another significant milestone for LTZ as it highlights the therapeutic potential of our U-MCE Platform for broad disease areas beyond our initial program,” said Robert Li, Ph.D., founder and chief executive officer of LTZ. “We are excited to initiate our second first-in-class myeloid engager immunotherapy, delivering novel therapeutic options for patients.”

LTZ's clinical development strategy for LTZ-232 initially prioritizes colorectal cancer supported by disease biology and internal data demonstrating consistent EpCAM expression alongside a myeloid-rich tumor microenvironment (TME). The program is designed with the flexibility to explore potential therapeutic activity across other tumor types.

“Advanced metastatic colorectal cancer remains a significant unmet need in oncology, particularly since it’s typically an ‘immunologically cold’ tumor microenvironment, limiting the effectiveness of many existing immunotherapies,” said William Grossman, M.D., Ph.D., chief medical officer of LTZ. “Our differentiated and novel approach is designed to redirect myeloid cells to drive anti-tumor activity in these challenging tumor microenvironment settings. We believe LTZ-232 has the potential to expand the reach of immunotherapy into cold solid tumors, and that we can meaningfully improve patients’ lives.”

About LTZ-232

LTZ-232 is a first-in-class bispecific antibody designed to activate tumor-associated macrophages (TAMs) to phagocytose and eliminate tumor cells in solid tumors with high EpCAM+ expression. Preclinical studies demonstrated potent pharmacology across in vitro and in vivo models, supported by a favorable safety profile. LTZ-232 transitions the company’s pipeline strategy into solid tumor indications, with an initial primary focus on advanced mCRC.

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 appear to be one of the most prevalent immune cell populations in TME of various 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 primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity and offer potential therapeutic benefit 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^TM) Platform, to improve clinical outcomes in patients with oncology and autoimmune diseases. With headquarters in Redwood City, California and 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/.