Immorna Announces 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 ofJCXH-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).

More information can be found at www.immorna.com or www.clinicaltrials.gov,identifier: NCT05871541.

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.