Immorna today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a Phase 1 multi-center study of JCXH-105.
| MORRISVILLE, N.C., Jan. 9, 2023 /PRNewswire/ -- Immorna, a rapidly expanding biotechnology company, focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to conduct a Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine against Shingles (Herpes Zoster). JCXH-105 represents Immorna’s first investigational vaccine targeting chronic infection caused by a latent virus. “We are excited to receive the third US IND clearance in less than 10 months for our innovative RNA-based pipeline asset, and further strengthen our portfolio,” 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. It is important to note that, as a vaccine based on Immorna’s srRNA technology, JCXH-105 can be administered at a significantly lower dose, which may cause less reactogenicity and significantly reduce the cost of production. Additionally, due to the synthetic nature of all JCXH-105 vaccine components, there are no raw material limitation or production bottlenecks. To the best of our knowledge, JCXH-105 may represent the first RNA-based Shingles vaccine entering clinical stage. JCXH-105 will be compared to GSK’s Shingrix (Zoster Vaccine, Recombinant, Adjuvanted) in this Phase 1 study.” Yuanqing (YQ) Liu, M.D., Ph.D., Immorna’s Chief Scientific Officer added, “JCXH-105 has been developed using Immorna’s propriety srRNA platform, which features improved immunogenicity and reactogenicity compared to the standard alphavirus RNA replicon. We chose to use srRNA because compared to the non-replicating conventional mRNA, srRNA strongly modulates T cell effector functions, while it is well known that cell mediated immunity (CMI) is the main mechanism of immune protection against Shingles. In preclinical testing, JCXH-105 elicited robust and durable antigen-specific T cell responses and increase of antibody titers in rodents as well as in non-human primates. Interestingly, both CD4+ and CD8+ T cell responses were strongly elevated in vaccinated monkeys, which was different from other vaccines that only elicited CD4+ T cell response as reported in the literature. On the delivery side, JCXH-105 takes advantage of Immorna’s propriety Ready-To-Use (RTU) nanoparticles. The vaccine is expected to be stable at 2-8°C for at least 18 months. Taken together, we strongly believe in the potential of JCXH-105 to become an effective vaccine against Shingles.” This Phase 1 study will be 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. Besides JCXH-105, Immorna has other srRNA vaccines targeting latent viruses in preclinical stage. More information can be found at www.immorna.com. About Immorna 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 |
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