- T-cell engagers (TCEs) have the most promising product profile across all deep B-cell depleting modalities
- Cizutamig (BCMA TCE) positioned as first and best-in-class for autoimmune diseases
- Over 60 patients with autoimmune diseases dosed with cizutamig and CND261 (CD20 TCE) bringing total clinical experience inclusive of oncology to nearly 200 patients
San Diego, CA, January 8, 2026: Candid Therapeutics, Inc. (“Candid”), a clinical-stage biotechnology company redefining the treatment of autoimmune and inflammatory diseases through novel T-cell engagers (TCEs), today announced continued clinical progress with cizutamig (BCMA TCE) and CND261 (CD20 TCE). Clinical evaluation is ongoing under multiple active INDs, investigator-initiated trials and compassionate use across ten clinical indications.
“In 2024, we started Candid with a hypothesis that TCEs could work similarly to cell therapy in autoimmune diseases. In 2025, clinical proof-of-concept for TCEs in autoimmune diseases was established,” said Dr. Ken Song, Chairman, President and CEO of Candid. “As we enter 2026, our focus is on a development strategy to maximize the commercial potential of TCEs and further establish Candid as the industry leading TCE company for autoimmune diseases.”
Cizutamig (BCMA TCE) has been administered in 80 patients, with half treated for autoimmune diseases. In autoimmune patients, cizutamig has demonstrated:
- On-target pharmacology with deep B-cell and plasma cell depletion in tissues
- Promising clinical efficacy in multiple autoimmune diseases including patients who have failed treatment with rituximab (anti-CD20 monoclonal antibody), efgartigimod (anti-FcRn), complement inhibitors, and other standard of care drugs
- A differentiated safety profile, with mild cytokine release syndrome (CRS) in fewer than 20% of patients and no immune effector cell-associated neurotoxicity syndrome (ICANS). Favorable tolerability has enabled outpatient dosing.
Based on promising clinical data, Candid is advancing cizutamig into global Phase 2 studies in two autoimmune disease indications in 2026. Ongoing clinical evaluation in ten indications will inform additional Phase 2 clinical development plans in the latter part of 2026.
CND261 (CD20 TCE) has been dosed in more than 110 patients, including over 20 patients with autoimmune diseases. In autoimmune patients, on-target pharmacology with deep B-cell depletion in tissues has been observed along with a favorable safety profile characterized by only Grade 1 CRS in fewer than 20% of patients and no ICANS. Candid plans to continue to generate early clinical data with CND261 to inform further development plans.
In parallel, Candid continues to expand its pipeline with multiple preclinical TCE programs including CND319, a dual targeting CD19 and CD20 TCE which will enter first-in-human trials this year.