Lifordi Immunotherapeutics, Inc., a clinical-stage biotech company developing antibody-drug conjugates (ADCs) for autoimmune and inflammatory disorders, presented nonclinical data on its lead candidate LFD-200 at the American College of Rheumatology (ACR) Convergence 2025 meeting. The company also announced that its Phase 1 study of LFD-200 in rheumatoid arthritis (RA) is underway, with initial data from healthy participants expected by the end of 2025.
The nonclinical data, presented in a poster titled “LFD-200, an Antibody Drug Conjugate that Selectively Delivers a Glucocorticoid Payload to Immune Cells, Provides Sustained Anti-inflammatory Effects Without Systemic Toxicity in Non-human Primates,” demonstrated that LFD-200 achieves sustained glucocorticoid (GC) exposures in immune cells for at least seven days after a single dose. Immunohistochemistry detected the GC payload in immune tissues of lymph nodes and spleen seven days post-dose, with no staining in the vehicle control. LFD-200 dose-dependently reduced proinflammatory cytokines such as TNFα and IL-1β after ex vivo stimulation of whole blood and bone marrow.
Importantly, LFD-200 did not suppress cortisol levels at clinically relevant doses. No change in cortisol was observed after a single dose up to 20 mg/kg for 14 days, unlike the dexamethasone control. After 13 weekly doses of LFD-200 at 25 mg/kg, no reduction in cortisol, bone formation marker P1NP, or bone mineral density was observed. This suggests the potential to harness glucocorticoid anti-inflammatory effects while limiting systemic toxicities.
“The ability to harness the anti-inflammatory effects of glucocorticoids while limiting systemic toxicities has been the ‘holy grail’ of autoimmune treatment for 75 years,” said Dr. Matthew W. McClure, Chief Medical Officer of Lifordi. “These data in NHPs show that a steroid can be delivered directly to immune cells with sustained exposures that deliver anti-inflammatory effects and have no impact on cortisol or bone biomarkers after 13 weekly clinically relevant doses of LFD-200.”
Arthur Tzianabos, Ph.D., President & CEO, stated, “Today we unveil that we have started our Phase 1 SAD/MAD clinical study of LFD-200 in RA, a multifactorial disease with a large unmet need, and confirm our plan to generate preliminary data from healthy participants by the end of 2025. In just over two years we have taken LFD-200 from the lab to the clinic, which is a major accomplishment reflecting the execution by our team and support from our Board of Directors, Clinical Advisors, and industry partners.”
Lifordi Immunotherapeutics is leveraging the success of ADCs to develop treatments for autoimmune and inflammatory disorders. The company’s platform targets myeloid and lymphoid cells using the VISTA protein. For more information, visit www.lifordi.com.
