BOSTON, March 02, 2026 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that its abstract detailing clinical results ongoing Phase 1/2 trial in systemic lupus erythematosus (SLE) for CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy, has been accepted as a late-breaking short oral presentation at the 15th European Lupus Meeting (ELM 2026). The presentation, to be delivered by Chief Medical Officer of Imviva Biotech, Jan Davidson-Moncada, M.D., Ph.D, will be featured in the Late Breaking session on March 6, 2026, at 14:01–14:09 CET. ELM 2026 is taking place March 4-7 in Lisbon, Portugal.
"These clinical results represent a significant advancement in our understanding of allogeneic CAR-T therapy for autoimmune disease," said Imviva Biotech Chief Executive Officer Lu Han. "The concept of immune-reset—where patients achieve deep, durable remission with repopulation by healthy, naïve B cells—demonstrates the transformative potential of our ANSWER platform. This is particularly meaningful for patients with lupus and other autoimmune diseases, who often face limited treatment options and the burden of chronic immunosuppression. We believe CTA313 has the potential to change the treatment paradigm in autoimmune disease."
The abstract highlights findings from Imviva's open-label Phase 1/2 study evaluating CTA313 in patients with active or refractory SLE and lupus nephritis treated with a single dose of CTA313 following standard dose lymphodepletion. As of the interim data cutoff on February 6th, 2026, 24 patients have been enrolled, including 14 patients (58.3%) with lupus nephritis. At a median follow-up of 6 months, CTA313 demonstrated robust clinical efficacy with 100% of patients achieving SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response, with 73.7% achieving LLDAS (Low Lupus Disease Activity State), and 42.1% achieving DORIS (Definition of Remission in SLE) remission at the last follow-up with a deepening trend. Additionally, 83.3% of patients achieved immunosuppression-free remission or glucocorticoid dose ≤10 mg/day.
CTA313 produced profound and sustained B-cell depletion followed by repopulation dominated by a naïve phenotype with limited memory/activated subsets. Anti-dsDNA antibodies declined rapidly to undetectable levels and remained suppressed through follow-up, additionally anti-Rubella vaccine titers remained undetectable. These findings are consistent with an "immune-reset" mechanism—evidence of fundamental immune system restoration that may enable prolonged remission in autoantibody-mediated autoimmune disease.
CTA313 demonstrated a favorable safety profile with cytokine release syndrome occurring in 41.7% of patients at Grade 1. No cases of immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, or lupus-induced cytokine-associated toxicity syndrome were reported. Infections occurred in 20.8% of patients overall, with Grade 3 or higher infections in 12.5%.
CTA313 incorporates Imviva's proprietary ANSWER™ (Antibody SWitch Engineered Receptor) platform, which enables enhanced pharmacokinetic persistence and improved therapeutic durability in the allogeneic setting. The therapy incorporates multiple genetic edits—including CIITA (Class II transactivator) knockout to prevent host immune rejection and T-cell receptor (TCR) knockout to prevent graft-versus-host disease—alongside dual targeting of CD19 and BCMA (B-cell maturation antigen).
For more information, visit www.imvivabio.com.
About CTA313
CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva's proprietary ANSWER™ inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy.
About Imviva Biotech
Imviva Biotech is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company's proprietary platform incorporates advanced cell engineering technologies to create off-the-shelf cellular immunotherapies. Imviva’s pipeline includes programs in both oncology and autoimmune indications.
Forward-Looking Statements
This press release contains forward-looking statements regarding product development and potential. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.
Contacts:
Investor Relations
Stephanie Carrington
ICR Healthcare
ImvivaBiotechIR@icrhealthcare.com
(646) 277-1282
Media Relations
Ally Stubin
ICR Healthcare
ImvivaBiotechPR@icrhealthcare.com
(646) 667-1861
