Imviva Biotech Presents Data Demonstrating Durable Clinical Responses from Ongoing Phase 1/2 Study of CTA313 in Systemic Lupus Erythematosus at ASGCT 2026

100% of patients treated with CTA313 achieved an SRI-4 response, with half achieving remission

BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced the presentation of new clinical and translational data from its ongoing open-label Phase 1/2 study of CTA313, its investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy, at the American Society of Gene & Cell Therapy’s Annual Meeting (ASGCT 2026). The conference is taking place May 11-15, 2026, in Boston, Massachusetts.

Current standard-of-care treatments for systemic lupus erythematosus (SLE) rely on broad immunosuppression and often fail to achieve durable remission. Many patients experience incomplete responses, recurrent flares, and long-term treatment-related toxicity, underscoring the need for novel approaches that address underlying immune dysfunction and provide sustained disease control.

“The clinical activity observed with CTA313 in systemic lupus erythematosus is highly encouraging, with 100% of patients achieving an SRI-4 response and 50% reaching remission at a median follow-up of six months,” said Ben Capoccia, Director of Translational Medicine and Clinical Research at Imviva Biotech. “Notably, in the non-renal SLE sub-cohort, 80% of patients reached remission, and 90% of those achieved immunosuppression-free remission. These outcomes, together with deep B-cell depletion and sustained suppression of pathogenic autoantibodies, support CTA313’s potential to deliver durable disease control through immune reset, with up to one year of follow-up in many patients.”

Imviva’s ASGCT presentation highlights encouraging clinical responses in SLE. Among 18 evaluable patients with SLE/lupus nephritis (LN) treated with CTA313, with a median follow-up of six months:

• 100% achieved an SRI-4 response
• 78% achieved Lupus Low Disease Activity State
• 50% achieved DORIS (Definition of Remission in SLE) remission in an SLE/LN mixed cohort
• 80% achieved DORIS in a non-renal SLE sub-cohort, in which 90% of those patients achieved immunosuppression-free remission
• Anti-dsDNA autoantibody clearance was achieved and maintained below detectable levels for 12 months
  

The data suggests that treatment with CTA313 induces deep and sustained B-cell depletion, followed by reconstitution of a predominantly naïve, non-autoimmune B-cell repertoire, supporting an immune-reset mechanism that may underpin durable clinical remission in patients with SLE.

Abstracts are currently available to the public at: https://annualmeeting.asgct.org/.

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

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