The Off-the-Shelf Revolution: A New Identity for Leukemia Treatment

BOSTON, MA – December 08, 2025 – In the world of advanced medicine, our own cells are being reprogrammed, given a new identity to hunt and destroy disease. This is the promise of CAR-T cell therapy, a treatment that has revolutionized the fight against blood cancers. Yet, this revolution has been hampered by a critical flaw: time. The standard process, which uses a patient's own cells, requires a manufacturing delay of one to two months—a lifetime for those with rapidly advancing leukemia. Now, data presented at the 67th American Society of Hematology (ASH) Annual Meeting suggests a breakthrough that directly addresses this human cost. Imviva Biotech has unveiled powerful results for CTD402, an allogeneic or 'off-the-shelf' CAR-T therapy, demonstrating that a powerful treatment can also be a timely one.

For patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) and acute myeloid leukemia (AML), two of the most aggressive and difficult-to-treat blood cancers, this is more than just a scientific advancement; it's a lifeline. Imviva's findings showcase not only impressive remission rates in these desperate patient populations but also the tangible benefit of a therapy that is ready when the patient needs it most, fundamentally altering the intersection of technology, trust, and the human layer in cancer care.

The Promise of 'Ready-to-Use' Cellular Identity

The core challenge of current CAR-T therapy lies in its personalized, or autologous, nature. T-cells are harvested from a patient, shipped to a lab, genetically engineered to recognize cancer cells, multiplied into the millions, and then shipped back for infusion. This bespoke process is a logistical marvel but also a bottleneck. Patients must be healthy enough to have their cells collected and stable enough to endure the weeks-long wait. For many with aggressive leukemias, their disease outpaces the manufacturing schedule.

Allogeneic therapy flips this model on its head. By using T-cells from healthy, pre-screened donors, companies can create large batches of a standardized, cryopreserved cell therapy product. This 'off-the-shelf' approach means the treatment is waiting for the patient, not the other way around. However, this introduces a new set of biological identity challenges: the risk of the donor cells attacking the patient's body (graft-versus-host disease, GvHD) and the risk of the patient's immune system rejecting the donor cells before they can do their job.

Imviva Biotech's CTD402 is engineered to solve this identity crisis. The therapy incorporates advanced gene editing to knock out the T-cell receptor (TCR), which prevents GvHD, and to remove HLA class II molecules, making the cells less visible to the host immune system. Combined with proprietary technology to enhance resistance to immune rejection, CTD402 is designed to be a universally compatible weapon. The data presented at ASH provides the strongest evidence yet that this complex biological engineering can translate into real-world clinical success. The safety profile was a standout, with no cases of GvHD or severe neurotoxicity observed—two of the most feared side effects in cell therapy—building critical trust in this novel platform.

Translating Code to Cure: The Clinical Evidence

Beyond its logistical advantages, a therapy is only as good as its ability to control disease. In two separate oral presentations, Imviva demonstrated that CTD402 delivers on this front. For patients with relapsed/refractory T-ALL and lymphoblastic lymphoma (T-ALL/LBL), the results were striking. Among 39 evaluable patients treated at the recommended dose, 64.1% achieved a complete remission. Critically, of those who responded, an overwhelming 91.7% achieved minimal residual disease (MRD) negativity, a deep level of remission that indicates no detectable cancer cells remain and is strongly associated with better long-term outcomes.

The data also showed that for patients who received a consolidative stem cell transplant after CTD402, the median overall survival had not yet been reached, suggesting the potential for durable, long-term cures. This stands in stark contrast to the 7.3-month median survival for patients who did not receive a transplant, underscoring the therapy's power as a bridge to a potentially curative procedure for patients who previously had no path forward.

The second presentation focused on a subset of R/R acute myeloid leukemia (AML) patients whose cancer expresses the CD7 protein, a marker associated with poor prognosis. CAR-T therapy has historically struggled to gain a foothold in AML. Yet, in a small cohort of eight patients with high CD7 expression, CTD402 induced a 62.5% response rate, with all responders achieving MRD-negative status. Some of these patients, when consolidated with a stem cell transplant, have maintained remissions for over four years, a remarkable outcome in a disease where relapse is common and often fatal.

"These results represent a potentially meaningful advance for patients with relapsed/refractory T-ALL/LBL and CD7+ AML," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD, in a statement. “CTD402 addresses a critical unmet need by harnessing the benefits of allogeneic CAR-T therapy while overcoming the limitations of existing approaches."

A New Identity for a Global Player

The clinical success of CTD402 coincides with a strategic evolution for the company itself, which recently rebranded from Bioheng Therapeutics to Imviva Biotech. This new corporate identity signals a clear ambition to move from a regional developer to a global player in the competitive cell therapy space. The ongoing global Phase 1b/2 clinical trial for CTD402, which is actively enrolling patients, is a testament to this worldwide strategy.

This ambition is bolstered by significant regulatory support from the U.S. Food and Drug Administration. The FDA has granted CTD402 both Regenerative Medicine Advanced Therapy (RMAT) and Rare Pediatric Disease Designation (RPDD) for T-ALL. RMAT designation provides intensive FDA guidance and eligibility for accelerated approval, potentially shortening the timeline to get the drug to patients. The RPDD, meanwhile, makes Imviva eligible for a Priority Review Voucher upon approval—a valuable asset that can be sold for hundreds of millions of dollars, providing non-dilutive funding to fuel further innovation.

This combination of compelling clinical data, a transformative manufacturing platform, and a savvy regulatory strategy positions Imviva Biotech as a company to watch. Its progress with CTD402 is not just a story about a single drug candidate; it represents a crucial step forward for the entire field of allogeneic cell therapy, offering a tangible vision of a future where the most powerful, personalized medicines are also accessible, immediate, and available to the vulnerable patients who need them most.