FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma
The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a phase 1 study set for mid-2025.
Lymphology hematopoietic system, medical illustration - Generative AI: © jovannig - stock.adobe.com
- The FDA cleared the investigational new drug (IND) application for LTZ-301 as a potential treatment for patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL).
- LTZ-301 is a first-in-class myeloid engager immunotherapy.
- A phase 1, open-label, multicenter study of LTZ-301 for treating R/R NHL is planned to begin in the second quarter of 2025.
The FDA has granted clearance to the IND application for LTZ-301, a first-in-class myeloid engager immunotherapy, for treating R/R NHL.1
LTZ-301 is the first investigational asset from the LTZ Therapeutics’ myeloid engager platform to advance into clinical trials to establish an initial proof of concept for myeloid engagement as a novel approach to immunotherapy.1
The company plans to initiate a phase 1, open-label, multicenter study of LTZ-301 for the treatment of patients with R/R NHL in the second quarter of 2025.
“The FDA’s clearance, signaling the initiation of our phase 1 study for LTZ-301, represents a significant milestone for the company,” said Robert Li, PhD, founder and chief executive officer of LTZ, in a press release. “We look forward to advancing our lead asset into the clinic to evaluate our myeloid engager approach and its potential as an effective therapy for cancer and other indications, such as autoimmune diseases.”
About LTZ-301
LTZ-301 is a bispecific myeloid engager antibody designed to selectively deplete CD79b-positive B-cells.2 The agent achieves this by enhancing antibody-dependent cellular phagocytosis through an Fc-gamma receptor-independent mechanism. CD79b is a tumor-associated antigen highly expressed in B-cell malignancies, including those resistant or relapsed after CD19- or CD20-directed therapies.1
By recruiting and redirecting monocytes and macrophages toward CD79b-positive B-cells, LTZ-301 promotes phagocytosis and subsequent depletion of malignant B-cells.
The initial clinical investigation of LTZ-301 plans to enroll patients with R/R NHL who have exhausted standard treatment options. Preclinical studies demonstrated robust pharmacologic activity in both in vitro and in vivo models, with LTZ-301 exhibiting a favorable safety profile.
“The company’s preclinical results have demonstrated promising activity and safety, suggesting applicability of LTZ’s platform to treat a variety of cancer indications and autoimmune diseases—where the unmet need is incredibly high,” said Wayne Godfrey, MD, MS, chief medical officer of LTZ, in the press release. “Through our first in-human trial, we aim to advance our understanding of the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LTZ-301, targeting CD79b-expressing B-cell lymphoma. I'm excited about the potential of LTZ’s innovative scientific approach and the opportunity to work with LTZ’s accomplished scientific team, with the end goal of improving patient outcomes.”
REFERENCES:
LTZ Therapeutics announces FDA clearance of IND application to initiate trial of first-in-class myeloid engager immunotherapy, LTZ-301. News release. LTZ Therapeutics. February 24, 2025. Accessed February 24, 2025. https://tinyurl.com/2u48ha8a
Myeloid engager pipeline. LTZ Therapeutics. Accessed February 24, 2025. https://ltztherapeutics.com/pipeline/
