By Phillip Mcleod
The US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for LTZ-301, a first-in-class bispecific myeloid engager immunotherapy, for patients with relapsed or refractory non-Hodgkin lymphoma (NHL).
The IND clearance was announced on February 24, 2025. Preclinical studies showed robust activity and a favorable safety profile. LTZ expects to initiate its phase 1, open-label, multicenter study in quarter two in 2025.
LTZ-301 selectively depletes CD79b-positive B-cells by enhancing phagocytosis. It targets CD79b, a tumor-associated antigen highly expressed in B-cell malignancies, including those resistant to CD19- or CD20-directed therapies, by recruiting monocytes and macrophages to remove malignant B-cells via an Fc-gamma receptor-independent mechanism, according to LTZ Therapeutics.
“The FDA’s clearance for our phase 1 study of LTZ-301 marks a significant milestone, and we aim to evaluate its potential as an effective therapy for [relapsed or refractory] NHL and other indications,” Robert Li, PhD, the founder and CEO of LTZ, said in the press release.
If successful, LTZ-301 could offer a novel immunotherapy approach for patients with limited treatment options, according to LTZ Therapeutics.
