Lifordi Immunotherapeutics, Inc., a clinical-stage biotechnology company developing antibody-drug conjugates (ADCs) for the treatment of autoimmune and inflammatory disorders, presented first-in-human data for LFD-200, the Company’s novel subcutaneously (SC) administered ADC delivering a potent glucocorticoid (GC) directly to immune cells. Phase 1 data from healthy participants (HPs) presented at EULAR 2026 (European Congress of Rheumatology), in London, UK, June 3-6, 2026, showed LFD-200 was well tolerated and demonstrated dose-responsive anti-inflammatory activity with no impact on serum cortisol levels, a sensitive marker for systemic GC toxicity. Dosing patients with moderate to severe rheumatoid arthritis (RA) in the Phase 1 study is ongoing with data expected by year-end 2026.
“We believe these data provide proof of mechanism for our VISTA-targeted ADC approach, which is designed to deliver a therapeutic payload directly to immune cells while avoiding the side effects associated with systemic exposure,” said Arthur Tzianabos, Ph.D., President & Chief Executive Officer. “By leveraging the unique properties of LFD-200 — including rapid uptake into immune cells, prolonged tissue residency, and anti-inflammatory activity — we believe we are establishing a differentiated approach to the treatment of autoimmune and inflammatory diseases. We look forward to seeing LFD-200 data in patients with RA.”
LFD-200 is a novel ADC composed of a monoclonal antibody (mAb) that is conjugated to 8 glucocorticoid payloads. The mAb is designed to selectively bind to the immune cell surface protein V-domain immunoglobulin suppressor of T cell activation (VISTA), rapidly internalize the GC payload, and have no other biological function. Nonclinical studies of subcutaneous dosing with LFD-200 in non-human primates1 (NHP) demonstrated sustained GC payload exposures in lymph nodes and spleen. Additionally, ex vivo stimulation of proinflammatory cytokines in whole blood and bone marrow samples was suppressed in a dose-responsive manner and no impact on cortisol was seen in any study, including after 13 weekly doses.
The Phase 1 clinical trial is a single and multiple ascending dose (SAD/MAD), randomized, double-blind, placebo- and active-controlled first-in-human study designed to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of LFD-200 in healthy participants and patients with moderate to severe RA.
Part 1: HPs [N=11/cohort (SAD) or N=8/cohort (MAD)]
SAD HP were randomized to receive a single dose of either oral prednisone (10 mg, open label; N=3), placebo (N=2), or SC LFD-200 (N=6; 1.5, 3, 6, or 12 mg/kg dose)
MAD HP were randomized to receive 4 weekly 5.5 mg/kg doses of SC LFD-200 (N=6) or placebo (N=2)
Part 2: Cohorts of patients with moderate to severe RA (N=14/cohort)
Randomization in each cohort is 8 LFD-200: 3 placebo: 3 prednisone with dosing for 12 weeks
In the poster (POS#1310) entitled “LFD-200, an Antibody Drug Conjugate that Selectively Delivers a Glucocorticoid Payload to Immune Cells, has a Favorable Risk-Benefit Profile vs. Prednisone and Placebo in a First in Human Study,” presented on Saturday, June 6, 2026, [10:15 am local time], Dr. Matthew W. McClure, Chief Medical Officer of Lifordi, shared data from 4 SAD and 1 MAD cohorts of HPs, which demonstrated:
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LFD-200 was safe and well tolerated
No serious adverse events
Treatment-emergent adverse events: No concerning findings/trends (Grade ≤2)
Laboratories/vital signs/electrocardiograms/physical examination: no concerning findings or trends
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LFD-200 plasma exposures were supportive of biweekly or monthly dosing
Serum half-life of ADC was ~30 hours, which is consistent with targeted uptake into VISTA+ cells
Steady state reached after 2nd dose
Free GC payload exposure persists beyond ADC detection, suggesting tissue exposure ≥2 weeks
LFD-200 had no impact on cortisol levels, a sensitive measure of systemic GC toxicity, at any time point after doses as high as 12 mg/kg (equivalent to ~170 mg of prednisone in a 70 kg HP)
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LFD-200 showed sustained and potent GC activity in whole blood*
TNFa levels after ex vivo lipopolysaccharide stimulation of whole blood samples in the SAD/MAD study demonstrated a dose-responsive effect for LFD-200 that was comparable to a single 10 mg dose of prednisone and was sustained. A similar effect was seen for IL-6 and IL-1β.
*Blood is not target tissue; Assay known to underrepresent in vivo effects in immune tissues
“These results demonstrate successful translation of our preclinical LFD-200 findings into humans and further validate our ability to deliver a potent glucocorticoid to immune cells and avoid the systemic side effects that have limited their use for decades,” said Dr. McClure. “Importantly, the safety profile observed in healthy participants — including no impact on cortisol levels — together with reductions in proinflammatory cytokines, strengthens our confidence that these findings may translate into meaningful benefit for patients with RA.”
For further details, view the poster here.
