BURLINGTON, MA – June 11, 2025 -- Lifordi Immunotherapeutics, Inc., a biotech company developing antibody-drug conjugates (ADCs) for the treatment of autoimmune and inflammatory disorders, presented preclinical data on its lead program for LFD-200, an ADC delivering a potent glucocorticoid (GC) directly to immune cells. Results of multiple in vitro and in vivo studies in mice and in non-human primates (NHPs) demonstrated that LFD-200 achieves targeted and sustained delivery of its GC payload to immune cells, resulting in efficacy without systemic toxicity. These data were presented at the European Alliance of Associations for Rheumatology (EULAR) meeting in Barcelona.
“This is Lifordi’s first data presentation on LFD-200, which demonstrates its unique mechanism of action to deliver a GC payload directly to immune cells, enabling rapid uptake by target tissues while avoiding the systemic toxicity that has precluded the broader use of steroids,” said Arthur Tzianabos, Ph.D., President & Chief Executive Officer. “We are looking forward to beginning a Phase 1 clinical study evaluating LFD-200 in the coming months and generating initial clinical data in healthy volunteers by the end of 2025.”
In the poster (POS#666) entitled “Immune-Targeted Glucocorticoid ADC for the Treatment of Autoimmune and Inflammatory Diseases,” Wednesday, June 11th, 3:30 – 4:30 pm CEST, Dr. Matthew W. McClure, Chief Medical Officer of Lifordi, presented results from non-clinical studies of LFD-200, which demonstrated:
- Anti-VISTA monoclonal antibody rapidly delivers GC payload directly to immune cells and avoids prolonged serum exposure
- VISTA (V-domain Ig Suppressor of T cell Activation) is highly expressed on myeloid cells, T cells, and plasma B cells, and rapidly internalizes the ADC
- Robust uptake of ADC leads to short serum PK (~14 hr half-life), limiting uptake by off-target tissues
- LFD-200 achieves sustained GC exposure in immune tissues, persisting for ≥7 days in NHPs
- Biodistribution data showed GC payload accumulation primarily in immune tissues for more than seven days compared to dexamethasone, which showed negligible drug concentrations in most tissues 24 hours post dose
- LFD-200 delivers GC to immune cells and persists for ≥8 days after a single dose in mice
- Immunohistochemistry/immunofluorescence studies showed drug in immune tissues at least 8 days post-dosing and demonstrated targeted payload delivery to T cells, myeloid cells, and high endothelial venules in lymph nodes and spleen
- LFD-200 showed no evidence of systemic GC toxicity after dosing for up to 4 months
- After up to 3 high doses (≤250 mg/kg) over ≤1 month in NHPs, there was no impact on cortisol levels
- After 16 weeks at an efficacious dose in mice, no off-target toxicity was observed, including no impact on corticosterone (mouse cortisol) or weight vs. treatment with dexamethasone, which showed profound reductions in cortisol levels
- LFD-200 achieved similar efficacy vs. GC in disease models
- At efficacious doses, LFD-200 prevented colitis development with similar efficacy to dexamethasone and disease control was observed for up to 3 weeks post dose
Lifordi has shown GC efficacy without systemic toxicity in other disease models including diabetes, arthritis, asthma and xeno-graft vs. host disease. In addition, LFD-200 has inhibited LPS-induced inflammatory cytokines in multiple in vitro and in vivo studies. The successful targeting of payloads, such as GCs, to the immune system while sparing non-immune tissues, as has been demonstrated with LFD-200, may offer a new way to treat autoimmune and inflammatory conditions across many disease areas including rheumatology, gastroenterology, pulmonology, and dermatology.
Lifordi Immunotherapeutics, Inc. is leading the way in leveraging the success of antibody-drug conjugates (ADCs) to develop treatments for autoimmune and inflammatory disorders. The Company’s lead ADC, LFD-200, has demonstrated efficacy in multiple preclinical disease models by targeting myeloid and lymphoid cells using a highly internalized cell surface membrane protein (VISTA). Lifordi has also applied its novel drug delivery platform to other diverse payloads, such as small molecules, antisense oligonucleotides (ASOs) and siRNA. As experienced drug developers in immunology and inflammatory diseases, together with expert clinical advisors, a strong partnering track record, and funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture to support initial clinical data, Lifordi is committed to changing how immune and inflammatory diseases are treated. For more information, please visit www.lifordi.com.
