BOSTON, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced the successful dosing of the first patient in the United States in the TENACITY-01 clinical trial (NCT07070219). The TENACITY-01 trial is evaluating CTD402, Imviva’s investigational allogeneic anti-CD7 CAR-T cell therapy, for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). This milestone marks a critical step toward addressing one of the most challenging hematological malignancies with limited treatment options and high mortality rates.
The patient was dosed at Stanford Medicine and experienced a well-tolerated safety profile with manageable adverse events. The patient was discharged ahead of typical treatment timelines and achieved complete remission (CRi), enabling advancement to proceed to consolidative hematopoietic stem cell transplantation.
The company plans to announce Phase 1b interim data by mid-2026, and the TENACITY-01 study is expected to be completed by late 2028. This timing enables progression to Phase 2 evaluation following Phase 1b readout, supporting the accelerated development pathway for this critical unmet need.
"Relapsed/refractory T-ALL/LBL remains one of the most difficult-to-treat blood cancers, with 40% of adults relapsing after first-line therapy and facing very limited options," said Jan Davidson-Moncada, MD, PhD, Imviva Biotech Chief Medical Officer. “The successful dosing of our first U.S. patient represents a meaningful milestone in bringing an innovative off-the-shelf CAR-T therapy to this underserved population. We are well-positioned to advance to Phase 2 in the near future and establish CTD402 as a therapeutic option for patients who urgently need better treatments.”
"The first patient’s rapid achievement of complete remission with manageable side effects suggests the clinical potential of CTD402," said Lori Muffly, MD, Investigator and Associate Professor, Division of Blood and Marrow Transplantation-Cellular Therapies, Stanford Medicine. “The trial’s design—combining standard-dose lymphodepletion with an off-the-shelf platform—represents a new approach to the unmet need in this patient population, and these early results encourage us as we enroll more patients to build the evidence for advancement.”
The ongoing global, single-arm, open-label TENACITY-01 trial is enrolling adolescents and adults (≥12 years) to evaluate the safety, efficacy, and cellular pharmacokinetics of CTD402. Phase 1b will enroll approximately 36 patients (~18 for dose exploration and ~18 at the recommended Phase 2 dose), followed by Phase 2 enrollment of approximately 36 patients. All participants will receive a standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells.
CTD402’s ready-at-point-of-care platform enables rapid treatment initiation, eliminating the 1-2 month manufacturing delays inherent to autologous CAR-T therapies. Primary endpoints include incidence of dose-limiting toxicities and overall complete remission rate, while secondary endpoints assess pharmacokinetics. Preliminary data from earlier studies demonstrate CTD402 achieved a 64.1% complete remission rate with 91.7% MRD-negative status in patients with R/R T-ALL/LBL, supporting its potential to address the critical unmet need in this patient population.
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.
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
