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First Subject Dosed in a Phase 1 Study of JCXH-105, a Self-Replicating RNA-Based Vaccine Developed for the Prevention of Shingles

MORRISVILLE, N.C., May 30, 2023. Immorna, a rapidly expanding biotechnology company focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the first subject has been dosed in the Company's First-In-Human (FIH) Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of Shingles (Herpes Zoster; HZ). JCXH-105 represents Immorna's first investigational vaccine targeting infection caused by a latent virus.

"The initiation of our FIH study with JCXH-105 is an important milestone for Immorna and for the development of a potential innovative vaccine for Shingles," said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. "If proven successful in clinical studies, JCXH-105 may become a valuable alternative to current standard-of-care to meet the large world-wide medical need for Shingles prevention. Due to its self-replicating nature, JCXH-105 may be effective at a significantly reduced dose level compared to a non-replicating conventional messenger RNA (mRNA) vaccine, and thereby may cause less reactogenicity and substantially reduce the cost of production. In addition, due to the synthetic nature of all JCXH-105 vaccine components, there are no raw material limitations or production bottlenecks."

This Phase 1 study is a randomized, double-blinded, multi-center, active-controlled study to assess the safety, immunogenicity, and determine the Recommended Phase 2 Dose (RP2D) for JCXH-105. The study will enroll healthy subjects aged 50 to 69 years. In this study, JCXH-105 will be compared to GSK's Shingrix (Zoster Vaccine, Recombinant, Adjuvanted).

About JCXH-105

JCXH-105 is a self-replicating RNA (srRNA)-based vaccine designed to prevent HZ (Herpes Zoster; Shingles) currently being developed by Immorna Biotherapeutics Inc.

In contrast to conventional mRNA vaccines, self-replicating RNA transiently generates double-stranded RNA intermediates during srRNA replication in transfected cells. This process consequently induces a strong innate immune response, which then amplifies the adaptive immune response to exert desired effector functions, especially through T cells, the main mechanism of immune protection against HZ. After intramuscular (IM) administration, the JCXH-105 vaccine expresses an engineered VZV antigen in vivo for longer period of time than non-replicating conventional mRNA, thereby stimulating the body to produce more durable immune responses for the prevention of HZ. Due to its self-replicating nature, JCXH-105 may be effective with a significantly reduced dose level compared to a non-replicating conventional mRNA vaccine.

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.

SOURCE Immorna

Posted: May 2023

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