Lifordi Immunotherapeutics, Inc., a clinical-stage biotechnology company developing antibody-drug conjugates (ADCs) for the treatment of autoimmune and inflammatory disorders, presented Phase 1 clinical data for LFD-200, the Company’s novel subcutaneously (SC) administered ADC delivering a potent glucocorticoid (GC) directly to immune cells, at the American College of Rheumatology (ACR) Convergence 2026 conference. Phase 1 data from healthy participants (HPs) demonstrated LFD-200 was well tolerated with dose-responsive anti-inflammatory effects and did not affect serum cortisol, a sensitive marker for systemic GC toxicity. Data from patients with moderate to severe rheumatoid arthritis (RA) treated with LFD-200 in the ongoing Phase 1b study are anticipated by the end of 2026.
“These data demonstrate the mechanistic advantage of applying our VISTA-targeting approach to deliver a glucocorticoid to immune cells and decoupling the efficacy of steroids from the systemic side effects,” said Arthur Tzianabos, Ph.D., President & Chief Executive Officer. “Early data from patients with severe RA in the first cohort show promising trends in safety as well as anti-inflammatory activity. While we await the full Cohort 1 data set, we continue to screen and enroll patients in additional cohorts to corroborate and bolster these results.”
LFD-200 is a novel ADC composed of a monoclonal antibody (mAb) that is conjugated to 8 glucocorticoid payload molecules. 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 whole blood and bone marrow samples suppressed release of pro-inflammatory cytokines in a dose-responsive manner and had no impact on cortisol levels 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 HPs 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 HPs 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 (10 mg) with dosing for 12 weeks
In the poster (Poster #0456) entitled “LFD-200, an Antibody Drug Conjugate that Selectively Delivers a Glucocorticoid to Immune Cells, has Anti-inflammatory Activity and was Well Tolerated Without Systemic Side Effects in an Ongoing Phase 1 Study,” presented on Sunday, November 8, 2026, [10:30 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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Single and multiple doses of LFD-200 were well tolerated
No serious adverse events
Treatment-emergent adverse events (Grade ≤2): No concerning findings/trends
Laboratories/vital signs/ECG/physical examination: No concerning findings/trends
No signs of GC toxicity, e.g., no hypertension, hyperglycemia, mood swings, insomnia, fatigue
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LFD-200 plasma exposures support biweekly or monthly dosing
Serum half-life of ADC was ~30 hours, consistent with active uptake into VISTA+ target cells
Free GC payload exposure persists beyond ADC detection, suggesting ≥2 weeks in tissue
>400 fold below the Cmax for 10 mg prednisone
LFD-200 did not affect cortisol, a sensitive marker for systemic GC toxicity, following doses up to 12 mg/kg (equivalent to ~170 mg of prednisone in a 70 kg HP)
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LFD-200 showed sustained and potent anti-inflammatory activity in blood*
TNFa levels after ex vivo lipopolysaccharide stimulation of blood samples demonstrated a dose-responsive suppressive effect 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
“The favorable safety profile observed in healthy participants, including the lack of effect on cortisol levels, affirms our belief in LFD-200 and its ability to bypass the systemic side effects associated with steroids while maintaining their anti-inflammatory activity,” said Dr. McClure. “Our goal is to show the benefit of our targeted drug delivery approach to help patients suffering from RA and broaden its potential to treat other autoimmune and inflammatory diseases in the future.”
For further details, view the poster here.
