Candid Therapeutics has achieved a significant milestone by dosing the first patients with its novel T-cell engager (TCE) therapies for autoimmune diseases, marking a pivotal moment in the company's mission to redefine treatment approaches for immune-mediated disorders. The clinical-stage biotechnology company announced that patients with refractory rheumatoid arthritis and systemic sclerosis have been dosed with therapeutically active doses of both cizutamig (BCMA TCE) and CND261 (CD20 TCE).
Clinical Progress Across Multiple Autoimmune Conditions
The company has rapidly expanded its clinical pipeline, with studies now underway across five distinct autoimmune diseases: IgA nephropathy, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. These studies are designed to evaluate safety, pharmacokinetics, pharmacodynamic effects, and early signs of efficacy in patients with immunology and inflammatory diseases.
Early clinical observations have been encouraging, with both TCEs demonstrating good tolerability profiles. Importantly, patients have shown early signs of promising clinical response and disease improvement, providing initial validation of the therapeutic approach in autoimmune settings.
Strategic Vision and Market Positioning
Dr. Ken Song, Chairman, President, and Chief Executive Officer of Candid, expressed ambitious goals for the technology platform. "We founded Candid on the conviction that T-cell engagers would become the largest therapeutic class in autoimmune diseases, surpassing the commercial success of TNF inhibitors such as Humira," Song stated. He emphasized the company's focus on execution and data generation, noting that "emerging clinical data with TCEs have solidified our confidence that TCEs can become the most compelling modality across a range of diseases."
Operational Infrastructure and Global Expansion
Candid has established comprehensive operational capabilities to support its clinical programs. The company has completed significant Chemistry, Manufacturing, and Controls (CMC) activities, including several new drug product manufacturing runs and the establishment of subcutaneous dosing formulations for both cizutamig and CND261.
To facilitate global clinical development, Candid has established a fully staffed legal entity in China, with a team that includes professionals with deep expertise in regulatory affairs, clinical development, and clinical operations.
Novel Therapeutic Mechanisms
Cizutamig is a bispecific antibody designed to simultaneously bind B-cell maturation antigen (BCMA) on B-cells and CD3 on T-cells, enabling T-cell-mediated cytotoxicity against BCMA-expressing B-cells. Originally developed and clinically evaluated in multiple myeloma, the therapy has demonstrated patient experience in oncology settings and is now being investigated in autoimmune diseases where pathogenic B-cells play a critical role in disease progression.
CND261 represents a complementary approach, targeting CD20 on B-cells and CD3 on T-cells. The molecule is engineered with low CD3 affinity to reduce the risk of excessive T-cell activation while maintaining potent and selective B-cell depletion. Like cizutamig, CND261 has demonstrated patient experience in B-cell malignancies and is now being evaluated in autoimmune conditions.
Company Foundation and Future Outlook
Candid launched in the second half of 2024 with substantial financial backing of $370 million and two in-licensed TCEs that had completed full Phase 1 dose escalation studies in oncology patients. The company plans to launch additional clinical studies in high-value disease indications during the second half of 2025, with further trial initiations and clinical data disclosures anticipated in the coming quarters.
