Immorna, a rapidly expanding biotechnology company, focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the first patient has been dosed at The University of Texas MD Anderson Cancer Center in the Phase 1 First-in-Human (FIH) trial of JCXH-211 in patients with malignant solid tumors. JCXH-211 is a novel, first-in-class, lipid nanoparticle (LNP) encapsulated self-replicating RNA (srRNA) encoding human interleukin (IL)-12 protein.

“We are thrilled to have dosed the first patient in this FIH trial at MD Anderson. The critically important role that IL-12 plays in providing immune antitumor response against cancer is well known and supported by strong pre-clinical anti-tumor activity,” said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. “Self-replicating RNA strongly stimulates innate immune response, which may help to re-shape the tumor microenvironment and convert an immunologically ‘cold tumor’ into a ‘hot tumor’. Additionally, the long in vivo half-life of srRNA helps extend the therapeutic window of this potent anti-tumor cytokine. We look forward to working with the investigators to bring this potential novel therapy to patients who are in dire need of new and effective treatments.”

IL-12 is a naturally occurring cytokine that plays a key role in the body’s immune response against cancer. Despite consistently showing potent antitumor activity in preclinical studies, the efficacy of recombinant IL-12 treatment at tolerable doses in humans failed to provide clinical benefit. Key challenges for recombinant IL-12 treatment include the short in vivo half-life and systemic toxicities associated with frequent dosing. Alternate IL-12 modality, such as the IL-12-encoding srRNA may overcome these hurdles and help realize the full therapeutic potentials of IL-12.

Zihao Wang, Ph.D., Co-Founder and Chief Executive Officer of Immorna added, “The start of this trial in the US marks a major milestone in the development of JCXH-211 and Immorna overall, as we demonstrate our continued ability to utilize Immorna’s diverse RNA and delivery platforms to develop innovative medicines and vaccines. We have great confidence in the potential of JCXH-211 as a novel anti-cancer treatment, based on the favorable safety profile and superior tumor-eradicating potency demonstrated in multiple preclinical animal and patient-derived xenograft models, which was better than similar investigational drugs employing conventional mRNA. We are excited and look forward to seeing the data of JCXH-211 unfold.” 

This multi-center Phase I FIH clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent JCXH-211 in patients with malignant solid tumors who have progressed following treatment with, or cannot tolerate available therapies, or for whom curative therapy does not currently exist. Enrollment in the trial is open to patients aged 18 years or older who have at least 1 tumor lesion amenable for IT injection, measurable disease per RECIST 1.1, adequate organ functions, and an ECOG performance status of 0 to 1.

More information can be found at www.immorna.com or www.clinicaltrials.gov, identifier: NCT05539157.

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.