Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune Diseases
Approval paves the way for CTA313 clinical study in the United States for patients with systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis
BOSTON, June 09, 2026 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for CTA313, a dual-targeting CD19/BCMA allogeneic CAR-T cell therapy designed to treat patients with B-cell-mediated autoimmune diseases. This milestone marks Imviva’s strategic expansion into autoimmune therapeutics, leveraging the company’s proprietary ANSWER™ platform technology to address significant unmet medical needs.
The FDA cleared Phase 1b basket design will evaluate the safety, efficacy, and cellular pharmacokinetics of CTA313 across multiple B-cell-mediated autoimmune conditions, including systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis. The innovative basket design allows for efficient evaluation across multiple indications while maintaining the flexibility to advance promising signals into Phase II development.
“This FDA clearance validates not only CTA313 as a therapeutic candidate, but the broader versatility of our ANSWER™ platform technology,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. “One of the most exciting aspects of our allogeneic approach is that CTA313 can be manufactured in advance and made readily available. Our off-the-shelf approach means eligible patients could potentially receive treatment more quickly – without the delays that can be life-threatening for those facing rapidly progressing disease – while also reducing their burden by eliminating the need for apheresis. This clearance moves us closer to making advanced cellular therapy accessible to the patients who need it most.”
Imviva Biotech maintains ongoing collaboration with the FDA, as demonstrated by the February 2025 IND clearance and January 2026 orphan drug designation for CD7-targeted therapy CTD402 in T-cell malignancies. This milestone reflects growing regulatory confidence in off-the-shelf CAR-T approaches.
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 renal, rheumatologic, endocrine, gastrointestinal, hematology, and autoimmune conditions.
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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