LTZ Therapeutics Receives FDA Approval for IND Application to Begin Trial of Novel Myeloid Engager Immunotherapy LTZ-301
Tuesday, February 25, 2025
LTZ Therapeutics, a biotechnology company focused on immunotherapy, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for LTZ-301. This first-in-class myeloid engager immunotherapy is designed to treat relapsed or refractory non-Hodgkin lymphoma (r/r NHL).
LTZ-301 is the company’s first candidate to progress to clinical trials, aiming to establish proof of concept for its myeloid engager approach in immunotherapy. A Phase 1, open-label, multicentre study is planned to begin in the second quarter of 2025.
LTZ Therapeutics is advancing its research by integrating reverse translational science with an in-depth understanding of tumour microenvironment (TME) biology, particularly myeloid biology. Macrophages are among the most common immune cells found in TME across different blood and solid tumours. Engaging and activating these cells to destroy cancer cells presents significant potential for treatment. The company’s Myeloid Engager Platform is being developed to enhance the phagocytic function of monocytes and macrophages in various states, supporting anti-tumour immunity.
Preclinical studies have shown promising activity and safety, indicating that LTZ’s platform could be used to treat a range of cancers and autoimmune diseases with high unmet medical needs. The first-in-human trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LTZ-301 in targeting CD79b-expressing B-cell lymphoma.
LTZ-301 is a bi-specific antibody designed to eliminate CD79b+ B-cells by enhancing Fc-gamma receptor (FcR)-independent antibody-dependent cellular phagocytosis (ADCP). CD79b is a tumour antigen receptor highly expressed in B-cell malignancies, including those resistant to existing CD19 or CD20-based treatments. LTZ-301 works by directing monocytes and macrophages towards CD79b+ B-cells, increasing phagocytosis and eliminating cancer cells. The initial trial will involve patients with r/r NHL who have no standard treatment options or for whom standard therapies have been unsuccessful. Preclinical studies have demonstrated strong pharmacological effects in both in vitro and in vivo models, with a favourable safety profile.
Soure: ltztherapeutics.com
