Two oral, and five poster presentations will showcase the company’s progress in developing allogenic cell therapy candidates for multiple hematological malignancies
CTD402 data for the treatment of T-ALL/LBL selected as a landmark study to be highlighted during 2026 ASH Highlights
BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced that it will showcase its pipeline through multiple presentations, including two oral presentations and five poster presentations, at the 67th American Society of Hematology (ASH) Annual Meeting, taking place from December 6-9, 2025, in Orlando, Florida.
The presentations showcase Imviva’s progress in allogenic cell therapy candidates being developed for multiple hematological conditions, including T-ALL/LBL, AML, B-ALL and severe aplastic anemia, as well as its manufacturing innovation.
The company will present the latest clinical data for CTD402, its investigational CD7 allogeneic CAR-T cell therapy, and CTA311, a universal anti-CD19 CAR-T cell therapy in development for patients with T-ALL/LBL, AML, B-ALL and severe aplastic anemia, and relapsed/ refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), respectively. An oral presentation on CTD402 in relapsed/refractory T-ALL/LBL has been selected as a conference highlight for the 2026 Highlights at ASH series, “How I Treat Acute Lymphoblastic Leukemia in 2025: Sequencing for Cure in the Era of Targeted and Novel Immune Therapies.”
"We will share the breadth and depth of our ANSWER™ platform, which addresses many limitations encountered by autologous and allogeneic CAR-T cell therapy,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. “This will include the breakthrough progress of our lead investigational product, CTD402, in treating leukemias. Two oral presentations will highlight the favorable safety and efficacy of CTD402 in patients with relapsed/refractory T-ALL/LBL and CD7+ AML, challenging hematological cancers with limited treatment options leading to high mortality. This data further validates the potential of our CD7 targeting strategy and our allogeneic cell platform, and we remain committed to bringing these innovative therapies to patients worldwide who urgently need better treatment options as soon as possible."
Imviva’s presentation schedule at ASH includes:
| Abstract Number | Abstract Title | Session Name | Presentation Time (US Eastern Time) |
| 1042, Oral Presentation | CTD402, allogeneic anti-CD7 CAR t-cell, in relapsed or refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) - report of clinical outcomes at the recommended phase 2 dose (RP2D) | 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Advancing Cell Therapies in T Cell Malignancies and AML | December 8, 5:15 PM - 5:30 PM |
| 816, Oral Presentation | CD7-targeted universal CAR T-cell therapy in relapsed or refractory (R/R) acute myeloid leukemia (AML): Clinical results from CTD401/402 studies | 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging CAR-T Cell Therapies for Acute Leukemias and Autoimmune Diseases | December 8, 11:45 AM - 12:00 PM |
| 5954, Poster Presentation | A single-arm, open-label, multi-center, phase 1b/2 Study to evaluate the safety, efficacy, and cellular pharmacokinetic profile of CTD402 in participants with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL) (TENACITY-01) | 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III | December 8, 6:00 PM - 8:00 PM |
| 3210, Poster Presentation | A Phase I, open-label study of CTD402, a universal CD7-targeting CAR T-cell therapy, in patients with relapsed/refractory severe aplastic anemia | 508. Bone Marrow Failure: Acquired: Poster II | December 7, 6:00 PM - 8:00 PM |
| 5920, Poster Presentation | CTA311, a universal anti-CD19 CAR t-cell therapy with improved persistence for patients with CD19+ relapsed/ refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL) | 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III | December 8, 6:00 PM - 8:00 PM |
| 4122, Poster Presentation | Target enrichment long-range sequencing (TLES) reveals structural variations missed by PEM-seq | 702. CAR-T Cell Therapies: Basic and Translational: Poster II | December 7, 06:00 PM - 8:00 PM |
| 4180, Poster Presentation | CTD402: Allogeneic CAR-T manufacturing that overcomes donor- & process-derived variation with robust clinical activity | 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster II | December 7, 6:00 PM - 8:00 PM |
Full abstract details can be found on the 2025 ASH Annual Meeting Abstracts website.
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 CTA311
CTA311 is an investigational ‘ready-at-point of care’ allogeneic anti-CD19 CAR-T cell therapy designed for B-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.
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.
Bioheng Therapeutics has rebranded to Imviva Biotech, reflecting the Company’s global expansion.
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
