MORRISVILLE, N.C., May 30, 2023 /PRNewswire/ -- 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).
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.
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"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."
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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.
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SOURCE Immorna
