NEWS

The announcement follows the recent IND clearance for CTD402 to be used in Imviva Bio’s Phase 1b/2 trial 

CTD402 is a CD7 Allogeneic CAR T-cell therapy designed for use in patients with T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) 

October 28, 2025 – 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 granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL). 

T-cell acute lymphoblastic leukemia represents a particularly challenging subset of ALL with a paucity of therapeutic option and poor outcomes in the relapsed/refractory setting. CTD402 is an off-the-shelf allogeneic CAR-T cell therapy designed to target CD7 while addressing key challenges in T-cell malignancies. 

RMAT designation is granted to regenerative medicine therapies that demonstrate the potential to address unmet medical needs for serious or life-threatening conditions. The designation is intended to facilitate efficient development and expedite review of therapies through early interactions with the FDA. 

"We are pleased to receive RMAT designation for CTD402.  This designation underscores the significant unmet need in relapsed/refractory T-ALL and the potential of our allogeneic CAR-T platform to address this challenging malignancy," Jan Davidson-Moncada, MD, PhD, CMO of Imviva Biotech. "RMAT designation enables more efficient collaboration with the FDA as we advance CTD402 through clinical development, bringing Imviva closer to delivering this potentially transformative therapy to patients who have limited treatment options." 

Robust Clinical Data Supporting RMAT Designation 

The RMAT designation is supported by compelling clinical data from ongoing Phase I/II trials involving approximately 100 patients. At the recommended Phase 2 dose (RP2D) of 400 million cells, CTD402 demonstrated: 

• 64.1% (76% CR/ 24% CRi) complete remission rate (CRR) in 41 heavily pretreated R/R T-ALL/LBL patients 
• 91.7% MRD-negative rate among responders, indicating deep remissions 
• Durable responses with median duration of response of 9.7 months (95% CI: 5.0 - not reached) 
• Efficacy in high-risk populations: 60.9% CRR in patients with high-risk molecular profiles and 59% CRR in patients with extramedullary disease 
• Favorable safety profile: predominantly mild-to-moderate cytokine release syndrome (78% of patients experienced CRS, with 66% Grade 1-2), with no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease 

The patient population treated represented a particularly challenging cohort: 37% were primary induction failures, 24% had relapsed post-allogeneic stem cell transplant, and 56% had high-risk molecular profiles. These results far exceed current standard of care outcomes in this difficult-to-treat population. 

"T-ALL/LBL in the relapsed or refractory setting has historically been associated with very poor outcomes and limited treatment options," said Jan, “CTD402's high rates of MRD-negative complete remissions in heavily pretreated patients, including those with high-risk disease features, represents a meaningful therapeutic advance in this disease. Moreover, CTD402 armed with the company’s proprietary ANSWERTM technology is administered following standard lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days), in contrast to many allogeneic CAR-T approaches that require intensive or augmented conditioning regimens. This standard dosing regimen contributes to CTD402's favorable safety profile while maintaining robust therapeutic efficacy, offering a safer treatment option for heavily pretreated patients who may be unable to tolerate more intensive lymphodepletion protocols.” 

About CTD402 

CTD402 is an investigational ‘off-the-shelf’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell hematologic malignancies. The product 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 is currently open and enrolling patients (NCT07070219). 

About RMAT Designation 

The RMAT designation program was established under the 21st Century Cures Act to facilitate efficient development and expedite review of regenerative medicine therapies for serious or life-threatening conditions. Benefits of RMAT designation include: 

Early interactions with FDA to discuss development plans and clinical trial design 

Potential eligibility for priority review and accelerated approval if relevant criteria are met 

Opportunity for rolling review of marketing applications 

About T-ALL/LBL 

T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma are aggressive hematologic malignancies with particularly poor outcomes in the relapsed/refractory setting. Current treatment options are limited, and patients who fail initial therapy or relapse after stem cell transplantation face dismal prognoses with median survival measured in months. The development of effective targeted therapies for R/R T-ALL/LBL represents a critical unmet medical need. 

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 the development and potential of CTD402. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. 

Contact:  

Investor relations: InvestorRelations@Imvivabio.com 

Media contact: Media@Imvivabio.com