Immorna Biotherapeutics Presents Clinical Data for JCXH-211, a Self-Replicating RNA Encoding the Human IL-12, at ASCO 2024

Research Triangle Park, N.C., June 1, 2024 – Immorna Biotherapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of RNA based prophylactic vaccines and therapeutics against infectious diseases, cancers, and rare genetic diseases, announces the presentation of clinical and biomarker data from its JCXH-211 clinical trials (NCT05727839) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31- June 4, in Chicago, IL.

“At ASCO 2024, we are excited to present the interim clinical data of our JCXH-211 trial. JCXH-211 is a first-in-class interleukin-12 (IL-12) therapeutic using a novel self-replicating RNA (srRNA) drug modality,” said NgocDiep Le, M.D., Ph.D., President and Global CMO. “JCXH-211 induces strong anti-tumor activities through multiple mechanisms of action: the potent anti-tumor activity of IL-12 and the strong immune stimulating capability of srRNA, which modulates the tumor microenvironment and turns a ‘cold’ tumor into an inflammatory ‘hot’ tumor. In the Phase 1a dose escalation study where JCXH-211 monotherapy is given intratumorally, JCXH-211 demonstrates an excellent safety and tolerability profile without dose-limiting toxicity (DLT) and strong biological activities as evidenced by robust immune cell tumor infiltration and levels of tumor growth control and/or shrinkages in the JCXH-211 monotherapy setting. The encouraging data warrant further clinical development. We look forward to initiating the JCXH-211 combination therapy trial with a check-point inhibitor (CPI). In the meanwhile, based on the differential and selective expression of srRNA in tumor tissues, we have submitted the IND application of JCXH-211 intravenous administration (IV) trial with a study design focusing on combination with a CPI. Finally, we would like to thank the patients and their families for participating in our trials, and our principal investigators and their teams for running these trials.”

Poster presentation details and conclusions include:

Title:   A Phase 1 Study to Evaluate the Safety and Tolerability of JCXH-211 (a Self-replicating mRNA Encoding IL-12) Intratumor Injection in Patients with Malignant Solid Tumors: Results from the Phase 1a Dose Escalation

Abstract Number: 2539

•       JCXH-211 IT is safe at the dose levels tested in patients with advanced solid tumors and cutaneous or subcutaneous lesions.

√  No TEAEs leading to dose reduction or discontinuation of study treatment. 

√  No TRAEs leading to dose reduction, dose interruption, discontinuation, or death. 

•       JCXH-211 IT exhibited biological activities in heavily pre-treated patients

√  Robust immune cell infusion into the tumors observed in almost all evaluable biopsy samples, suggesting re-modulating of the tumor microenvironment.

√  The sizes of injected lesions for majority patients showed growth control and/or shrinkage.

√  Tumor shrinkage of 31% was observed in a non-injected lesion suggesting abscopal effects.

√  Pharmacodynamic changes include:

▶  Only slightly increased serum IFN-γ levels with peak observed 1 day post treatment.

▶  All values of IL-12p70 were below the BLQ, consistent with limited off-target systemic toxicity.

▶  IL-6, a biomarker indicative of systemic inflammation, was barely detectable or BLQ at all time points in the periphery of all patients. 

•       The results obtained for JCXH-211 IT demonstrated the advantage of srRNA-based modality, which can limit systemic exposure and off-target toxicity while enhancing immune cell infiltration in the tumor and inflaming the tumor microenvironment. 

•       Trial of JCXH-211 IT with CPI combination therapy will be initiated.   

About Immorna

Immorna is a rapidly expanding biotechnology company, focusing on the development of RNA-based therapeutics and vaccines. Immorna is utilizing multiple RNA platforms, including conventional, self-replicating and circular RNA.

Since its founding in 2019, Immorna has built a robust CMC platform for RNA synthesis, purification, and analytical testing that is well suited for clinical and commercial development. In addition, with its state-of-the-art screening tools, Immorna has developed an arsenal of RNA delivery vehicles, including polymers and lipid nanoparticles featuring multiple proprietary ionizable cationic lipids suitable for intramuscular, intravenous and tissue-targeting delivery.

Immorna has a growing intellectual property portfolio and a diverse RNA development pipeline spanning cancer immunotherapy, infectious diseases, rare genetic diseases, and medical cosmetology, and quickly advancing its oncology drug and infectious disease vaccine candidates into clinical stages.