Candid Therapeutics Advances T-Cell Engagers to Phase 2 Studies for Autoimmune Diseases
核心洞察
Candid Therapeutics (搜索) announced plans to initiate global Phase 2 studies for cizutamig (搜索) (BCMA (搜索) TCE) in two autoimmune disease indications in 2026, following promising clinical data from 80 patients.
The company has dosed over 60 patients with autoimmune diseases (搜索) using cizutamig (搜索) and CND261 (CD20 (搜索) TCE), bringing total clinical experience to nearly 200 patients across oncology and autoimmune indications.
Cizutamig (搜索) demonstrated deep B-cell and plasma cell depletion with a differentiated safety profile, showing mild cytokine release syndrome in fewer than 20% of patients and no neurotoxicity.
Candid Therapeutics (搜索) announced plans to advance its T-cell engager (TCE) therapies into multiple Phase 2 studies for autoimmune diseases (搜索) in 2026, following promising clinical data that established proof-of-concept for this novel therapeutic approach. The San Diego-based clinical-stage biotechnology company has positioned its lead candidate cizutamig (搜索) as a first and best-in-class BCMA (搜索) TCE for autoimmune diseases.
Clinical Progress and Patient Experience
Cizutamig (搜索) (BCMA (搜索) TCE) has been administered to 80 patients, with half receiving treatment for autoimmune diseases (搜索). The company has dosed over 60 patients with autoimmune diseases across both cizutamig and CND261 (CD20 (搜索) TCE), bringing total clinical experience including oncology applications to nearly 200 patients.
"In 2024, we started Candid with a hypothesis that TCEs could work similarly to cell therapy in autoimmune diseases (搜索). 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 Clinical Profile
In autoimmune patients, cizutamig (搜索) has demonstrated on-target pharmacology with deep B-cell and plasma cell depletion in tissues. The therapy showed promising clinical efficacy across multiple autoimmune diseases (搜索), including in patients who had failed treatment with established therapies such as rituximab (anti-CD20 (搜索) monoclonal antibody), efgartigimod (anti-FcRn), complement inhibitors, and other standard of care drugs.
The safety profile has been differentiated from other approaches, with mild cytokine release syndrome (CRS) occurring in fewer than 20% of patients and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). This favorable tolerability profile has enabled outpatient dosing for patients.
Development Strategy and Pipeline Expansion
Based on the promising clinical data, Candid is advancing cizutamig (搜索) into global Phase 2 studies in two autoimmune disease indications in 2026. Ongoing clinical evaluation across ten indications will inform additional Phase 2 clinical development plans in the latter part of 2026.
CND261 (CD20 (搜索) TCE) has been dosed in more than 110 patients, including over 20 patients with autoimmune diseases (搜索). In autoimmune patients, the therapy demonstrated on-target pharmacology with deep B-cell depletion in tissues and a favorable safety profile characterized by only Grade 1 CRS in fewer than 20% of patients and no ICANS. Candid plans to continue generating early clinical data with CND261 to inform further development plans.
The company is also expanding its pipeline with multiple preclinical TCE programs, including CND319 (搜索), a dual targeting CD19 (搜索) and CD20 (搜索) TCE that will enter first-in-human trials this year. Clinical evaluation is ongoing under multiple active INDs, investigator-initiated trials and compassionate use across ten clinical indications.