RD-0605

BOSTON, May 29, 2026 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that it will present data on CTA313, its investigational dual-targeted CD19/BCMA allogeneic CAR-T cell therapy for Systemic Lupus Erythematosus (SLE), at the European Alliance of Associations for Rheumatology 2026 Congress (EULAR) in London from June 3-6, 2026. Additionally, the company will showcase data on CTD402, its allogeneic CAR-T cell therapy candidate being developed for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL), at the European Hematology Association 2026 Congress (EHA) in Stockholm from June 11-14, 2026. EULAR 2026 publication details: CTA313, CD19/BCMA Dual Targeted Allo-CAR-TANS Cell, Durable Remission in Systemic Lupus Erythematosus following Deep B-Cell Depletion, Suggestive of Immune-Reset Abstract: AB1118 Abstracts are currently available to the public at: . EHA2026 presentation details: CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL Abstract: EHA-3404 Short: PS2331 Session Title: Gene therapy, cellular immunotherapy and vaccination - Clinical Session Type: Poster Session Date & Time: Saturday, June 13, 18:45 CEST Speaker: Dr. Xian Zhang, Hebei Yanda Ludaopei Hospital TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL) Abstract: EHA-2777 Short: PS2350 Session Title: Gene therapy, cellular immunotherapy and vaccination - Clinical Session Type: Poster Presentation Date & Time: Saturday, June 13, 18:45 CEST Speaker: Dr. Lori Muffly, Professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Medicine, Palo Alto Abstracts are currently available to the public at: *menu=6*browseby=3*sortby=2*ce_id=2934 . “These presentations at EULAR and EHA underscore the transformative potential of our ANSWER™ platform to deliver readily available, off-the-shelf CAR-T therapies for patients with serious autoimmune diseases and hematologic malignancies,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. “We’re encouraged by the progress we’re making toward our goal of bringing innovative treatments to patients in need and look forward to continuing to advance our pipeline and mission.” For more information, visit 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 CTD402 CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva's proprietary ANSWER™ inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an 'off-the-shelf' allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease. A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL). 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

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: . For more information, visit . 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