LTZ Therapeutics Gets FDA Nod to Begin Trial for LTZ-301 Immunotherapy

REDWOOD CITY, CA, USA & SHENZHEN, China – February 24, 2025 – LTZ Therapeutics, a biotechnology company specializing in immunotherapy, has announced that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for LTZ-301. This cutting-edge myeloid engager immunotherapy is designed to treat patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL).

LTZ-301 marks the first product from LTZ’s innovative platform to progress to clinical trials, with the aim of validating their myeloid engager strategy in fostering effective immunotherapy. The company anticipates launching their Phase 1, open-label, multicenter clinical study in the second quarter of 2025.

Robert Li, Ph.D., the Founder and CEO of LTZ, highlighted the significance of the FDA’s clearance, which paves the way for the initiation of LTZ-301’s Phase I study. He expressed enthusiasm about bringing their lead asset into clinical settings to assess its potential as a treatment for cancer and possibly other conditions like autoimmune diseases. Li also noted the strategic strengthening of LTZ’s scientific and clinical leadership with the appointment of Dr. Wayne Godfrey as Chief Medical Officer in October 2024 and the addition of Dr. Alan J. Korman, a highly respected figure in cancer immunology, to their scientific advisory board.

LTZ’s strategy involves a unique fusion of reverse translational science and an intricate understanding of tumor microenvironment (TME) biology, with a particular focus on myeloid biology. Macrophages, a predominant immune cell type within the TME of numerous hematologic and solid tumors, play a crucial role in LTZ’s approach. The company is developing the Myeloid Engager Platform to enhance the phagocytic capabilities of monocytes and macrophages, thereby promoting anti-tumor immunity.

Dr. Godfrey emphasized the promising preclinical results of LTZ’s platform, which indicate its potential applicability in treating a broad range of cancers and autoimmune diseases, where there remains a significant unmet need. He elaborated on the goals of their first in-human trial, which are to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of LTZ-301, specifically targeting CD79b-expressing B-cell lymphoma. He expressed excitement about working with the accomplished team at LTZ and the potential impact of their pioneering scientific approach on patient outcomes.

LTZ-301 is a novel myeloid engager bi-specific antibody that targets CD79b+ B-cells. It functions by enhancing antibody-dependent cellular phagocytosis (ADCP) independent of Fc-gamma receptor (FcγR) activity. CD79b is prominently expressed in B-cell malignancies, including those resistant to existing therapies targeting CD19 or CD20. LTZ-301 directs monocytes and macrophages to CD79b+ B-cells, facilitating increased phagocytosis and elimination of cancer cells. The initial study will involve patients with r/r NHL who lack standard treatment options or have not responded to conventional therapies. Preclinical findings have shown LTZ-301 to have potent pharmacological effects and a favorable safety profile in both laboratory and animal studies.

LTZ Therapeutics, with operations in Redwood City, California, Shenzhen, China, and a team in Heidelberg, Germany, is dedicated to advancing novel immunotherapies. Their focus is on overcoming treatment resistance and enhancing anti-tumor immunity through their Myeloid Engager Platform and a deep understanding of tumor microenvironment biology.