REDWOOD CITY, Calif. & SHENZHEN, China--(BUSINESS WIRE)--LTZ Therapeutics, an immunotherapy-focused biotech company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma (r/r NHL).
LTZ-301 is the first asset in the company’s platform to enter clinical trials to determine an initial proof of concept for their myeloid engager approach, to foster immunotherapy. LTZ expects to initiate its Phase 1, open-label, multicenter study in Q2 2025.
“The FDA’s clearance, signaling the initiation of our Phase I study for LTZ-301, represents a significant milestone for the company,” said Robert Li, Ph.D., Founder and CEO of LTZ. “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. Additionally, the recent appointment in October 2024 of Dr. Wayne Godfrey, as LTZ’s Chief Medical Officer, strengthens our company’s scientific and clinical leadership – providing us with great optimism as we move forward in our next phase of clinical development. We’re also delighted to welcome Dr. Alan J. Korman, a globally recognized pioneer in cancer immunology, to LTZ’s scientific advisory board.”
LTZ’s approach focuses on the fusion of reverse translational science, with a deep understanding of tumor microenvironment (TME) biology – especially myeloid biology. Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells offers significant therapeutic potential for patients. LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity.
“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 Dr. Godfrey. “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.”
About LTZ-301
LTZ-301 is a novel myeloid engager bi-specific antibody that depletes CD79b+ B-cells via enhancing Fc-gamma receptor (FcγR)-independent antibody dependent cellular phagocytosis (ADCP). CD79b is a unique tumor antigen receptor that is highly expressed in B-cell malignancies, including the ones of relapse/resistance to the existing CD19 or CD20-based therapies. LTZ-301 works by redirecting monocytes and macrophages toward CD79b+ B-cells, leading to enhanced phagocytosis and depletion of cancer cells. The initial study of LTZ-301 will be conducted in patients with r/r NHL for whom no standard therapy is available or where standard treatment has failed. Preclinical studies of LTZ-301 demonstrated potent pharmacology in both in vitro and in vivo studies with a favorable safety profile.
About LTZ
LTZ Therapeutics is an immunotherapy-focused biotech company pursuing the development of novel therapies, with the company’s novel Myeloid Engager Platform, to improve clinical outcomes in patients with cancer and autoimmune diseases. With main operations in Redwood City, California and Shenzhen China as well as a team out of Heidelberg Germany, LTZ is dedicated to developing novel immunotherapies capable of overcoming resistance and boosting anti-tumor immunity based on reverse translational science and emerging disease biology of tumor microenvironment. For more information, please visit https://www.ltztherapeutics.com/.
Contacts
Media Contact:
Betsy Levy
betsy.levy@ltztherapeutics.com
415-377-3112
