Candid Therapeutics Plans to Initiate Multiple Phase 2 Studies Following Promising Clinical Data of T-cell Engagers in Autoimmune Diseases

• 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–(BUSINESS WIRE)–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.

About Candid Therapeutics

Candid Therapeutics is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune and inflammatory diseases through novel T-cell engager (TCE) platforms. Candid is advancing two lead B-cell depleting TCEs, with a goal to broadly explore the potential of TCEs across multiple autoimmune diseases by targeting different B-cell protein targets, as well as evaluating different depths of B-cell depletion. Established in 2024 and headquartered in San Diego, CA, Candid is led by a team of entrepreneurial executives who have a track record of advancing programs into and through development and is supported by a distinguished syndicate of premier life science investors.

About Cizutamig

Cizutamig is a bispecific antibody that can bind to B-cell maturation antigen (BCMA) on B-cells and CD3 on T-cells, enabling T-cell–mediated cytotoxicity against BCMA-expressing B-cells. Purposely designed to maintain cytotoxicity while limiting cytokine release, cizutamig has been clinically evaluated in patients with multiple myeloma and autoimmune diseases. Clinical efficacy and differentiated safety compared to other BCMA TCEs have been demonstrated. Cizutamig is currently in multiple clinical studies across various autoimmune diseases.

About CND261

CND261 is a bispecific antibody that can bind to CD20 on B-cells and CD3 on T-cells, enabling T-cell mediated cytotoxicity against CD20-expressing B-cells. Engineered with low CD3 affinity, CND261 is optimized to reduce the risk of excessive T-cell activation while maintaining potent and selective B-cell depletion. CND261 has been clinically evaluated in patients with lymphoma and autoimmune diseases. Clinical efficacy and differentiated safety compared to other CD20 TCEs have been demonstrated. CND261 is currently in multiple clinical studies across various autoimmune diseases.

Contacts

Arvind Kush

[email protected]