Immorna Receives IND Clearance to Conduct a Phase 1/2 Study of JCXH-221, a Broadly Protective mRNA-Based COVID-19 Vaccine

MORRISVILLE,N.C.,Nov. 21,2022 -- 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 1/2 multi-center study ofJCXH-221,a lipid nanoparticle (LNP) complexed broadly protective mRNA vaccine against SARS-CoV-2 infection and diseases. The goal of this multi-center study is to assess the safety and immunogenicity of JCXH-221 in healthy adult subjects.

"We are excited to receive our second US IND clearance this year 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. "Vaccination remains a key component of the complex approach required to reduce the impact of SARS-CoV-2 infection and diseases. The continued emergence of new variants,the waning of the immune response after vaccination,and the limited availability of currently approved vaccines in lower-income countries,necessitate the development of new COVID-19 vaccine candidates with broadly protective potential and ready availability for rapid pandemic response. We strongly believe that JCXH-221 is an excellent vaccine candidate to address this unmet medical need."

JCXH-221 is a mono-valent yet broadly protective mRNA-LNP vaccine. Once administered,the single chain mRNA will translate and be spontaneously assembled into multimers that contain immune epitopes from several SARS-CoV-2 strains. The multimer configuration is believed to further enhance their immunogenicity. In preclinical testing,JCXH-221 elicited robust neutralizing antibodies against an assay of viral strains,including the ancestral,Beta,Delta,Omicron BA.1,BA.2.12.1,and BA.4/5. JCXH-221 is formulated with a thermal stable nanoparticle delivery system that is stable at 2-8°C for at least 18 months.

Zihao Wang,Co-Founder and Chief Executive Officer of Immorna added,"The COVID-19 virus will likely remain a challenge for the foreseeable future and continue to evolve. New variants may be able to evade the protective immunity that individuals have established from prior infection or immunization. A resurgence of the past,more lethal,variants could also have a devastating effect on those whose immunity has waned. Therefore,we believe developing a broadly protective (ideally universal) COVID-19 vaccine is critically important to keep this virus under control. Additionally,lessening the ultra-low temperature storage and transportation requirements could enable a more affordable and accessible vaccine option worldwide. We believe the combined features of JCXH-221 could address these needs and make it well positioned to become a next generation vaccine against this evolving pandemic."

The Phase 1 part of this study will be a randomized,double-blinded,placebo-controlled,dose-escalation study to assess the safety,immunogenicity,and determine the Recommended Phase 2 Dose (RP2D) for JCXH-221. The Phase 2 part will be a randomized,active-controlled study to further characterize the safety and immunogenicity of JCXH-221 at the RP2D.

More information can be found atwww.immorna.com.

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.

Website: www.immorna.com

E-mail: info@immornabio.com

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