Morrisville, NC – June 30, 2026 – Immorna Biotherapeutics, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics, today announces positive clinical data for JCXH-213, its novel in vivo CAR-T candidate, in patients with immune thrombocytopenia (ITP). Two patients with refractory and relapsed ITP, who had previously failed first- and second-line therapies and were treated by the starting low-doses of JCXH-213, achieved rapid and complete B-cell depletion in both peripheral blood and bone marrow tissues. Platelet counts increased significantly and steadily. Both patients achieved Complete Response (CR) by Day 8 following the first administration, demonstrating quick and significant clinical benefits. On the safety side, JCXH-213 was well tolerated with only limited adverse events.

These data further support the potential of JCXH-213 as a re-dosable in vivo CAR-T therapy that does not require ex vivo cell manufacturing or lymphodepleting preconditioning, offering a new treatment option for patients with ITP and other B cell-mediated autoimmune diseases.

‘Immune thrombocytopenia is a bleeding autoimmune disorder mediated by immune system dysregulation, in which pathogenic B cells and the anti-platelet autoantibodies they produce play an important role in disease onset and relapse,’ said Dr. Yuanqing Liu, CSO of Immorna. ‘Deep depletion of abnormal B cells using an in vivo CAR-T strategy has the potential to reset immune homeostasis at the mechanistic level. We are pleased to see that JCXH-213 has demonstrated encouraging safety, tolerability and efficacy in patients with ITP. In addition, in the JCXH-213 trial imitated earlier for treatment of systemic sclerosis (SSc), JCXH-213 achieved complete B-cell depletion in peripheral blood, lymph nodes and bone marrow in all treated patients. Upon finishing the treatment regiment, complete B cell depletion persisted for nearly two months, accompanied by sustained clinical benefits. These exciting clinical data highlight the strong efficacy of Immorna’s mRNA-LNP based in vivo CAR-T platform in B-cell depletion and immune reset, as well as its potential in broad application against autoimmune diseases.’

Immorna’s tLCNP Platform Continues to Demonstrate Differentiated Advantages

JCXH-213 utilizes Immorna’s proprietary active-targeting tLCNP platform, which incorporates a chemically conjugated proprietary CD8 antibody to enable efficient and specific transfection of CD8⁺ T cells. The platform demonstrates good spleen tropism and the ability to efficiently transfect naïve T cells, enabling CAR-expressing T cells to actively search for and eliminate B cells inside the body. Clinical data generated to date by Immorna demonstrated that, following administration of JCXH-213, CAR positivity of CD8⁺ T cells in peripheral blood was highly significant, while CAR positivity in CD4⁺ T cells was essentially undetectable. This marked contrast demonstrates the high specificity of Immorna’s tLCNP delivery platform to target cytotoxic CD8⁺ T cells.

Scalable Manufacturing Capabilities Support Clinical Development and Future Commercialization

Immorna has established a robust manufacturing process for JCXH-213, along with a comprehensive analytical characterization and release assay panel. The current batch scale supports 3,000 doses per batch, with the capability to rapidly expand to 20,000 doses or more per batch while maintaining strong batch-to-batch consistency. In addition, through extensive formulation optimization, the company continues to improve the stability of JCXH-213 under the intended storage condition, laying a solid foundation for future multicenter clinical studies and commercialization.

About JCXH-213

JCXH-213 is an investigational in vivo CAR-T therapy that uses mRNA-LNP technology to generate CAR-positive T cells directly in vivo. The candidate incorporates Immorna’s proprietary active-targeting tLCNP platform, designed to specifically and efficiently transfect CD8⁺ T cells. Compared with conventional ex vivo CAR-T therapies, JCXH-213 does not require ex vivo cell manufacturing, individualized cell production or lymphodepleting preconditioning, and has the potential for repeated dosing and scalable manufacturing.

About Immorna

Immorna is a clinical‑stage biotechnology company focused on developing next‑generation RNA therapeutics. Leveraging proprietary delivery and manufacturing platforms supported by a robust IP portfolio, Immorna is advancing a pipeline of in vivo cell therapies and mRNA‑based medicines to address serious diseases with high unmet medical need.