LTZ Therapeutics received FDA clearance for its Investigational New Drug (IND) application for LTZ-301. LTZ-301, a first-in-class myeloid engager immunotherapy, will be investigated for the treatment of relapsed or refractory non-Hodgkin lymphoma (r/r NHL). The company plans to initiate a Phase 1 clinical trial in Q2 2025.
This IND clearance is a crucial step in validating LTZ’s myeloid engager platform. It opens the door to clinical investigation of a novel therapeutic approach for r/r NHL, a patient population often facing limited treatment options after standard therapies fail. Success in this trial could establish a new treatment paradigm for these patients and broaden the applicability of myeloid engager therapies to other cancers and autoimmune diseases.
The Phase 1 study will be a multicenter, open-label trial evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of LTZ-301. LTZ-301 is a bi-specific antibody designed to enhance the phagocytic function of monocytes and macrophages, targeting them to eliminate CD79b-expressing B-cell lymphoma. Preclinical data suggests LTZ-301 shows promising activity and a favorable safety profile. The appointment of Dr. Wayne Godfrey as Chief Medical Officer and Dr. Alan J. Korman to the scientific advisory board further strengthens LTZ’s leadership in this area.
This IND clearance allows LTZ to translate promising preclinical findings into clinical investigation. Positive results from the Phase 1 trial could pave the way for further clinical development of LTZ-301, potentially offering a new and effective treatment option for patients with r/r NHL. It could also spur further development of LTZ’s myeloid engager platform for other indications, marking a significant advancement in the immunotherapy landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
