Immorna has received approval to study an mRNA-based vaccine against Covid-19

US biotech company Immorna announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a phase 1/2 multicenter study of JCXH-221, a lipid nanoparticle (LNP) complex with broad protective mRNA vaccine against SARS-CoV-2 infection and disease.

The objective of the multicenter study is to evaluate the safety and immunogenicity of JCXH-221 in healthy adults.

“We are pleased to receive the second US IND approval this year for our innovative RNA-based pipeline and further strengthen our portfolio,” said NgocDeep Le, Chief Medical Officer of Immorna.

“Vaccination remains a key component of the comprehensive approach needed to reduce the impact of SARS-CoV-2 infection and disease. The constant emergence of new variants, the decline of the immune response after vaccination, and the limited availability of currently approved vaccines in low-income countries call for the development of novel candidate vaccines against Covid-19 with broad protective potential and availability for a rapid pandemic response. We strongly believe that JCXH-221 is an excellent vaccine candidate to address this unmet medical need.”

JCXH-221 is a monovalent but broadly protective mRNA-LNP vaccine. After administration, single-stranded mRNA will be translated and spontaneously assemble into multimers containing immune epitopes from multiple SARS-CoV-2 strains. The multimeric configuration is believed to further enhance their immunogenicity. In preclinical testing, JCXH-221 elicited robust neutralizing antibodies against virus strains including ancestral, Beta, Delta, Omicron BA.1, BA.2.12.1, and BA.4/5. JCXH-221 consists of a thermostable nanoparticle delivery system stable at 2-8°C for at least 18 months.

Global option

Zihao Wang, co-founder and chief executive officer of Immorna, added: “Covid-19 is likely to remain a challenge for the foreseeable future and will continue to evolve. The new variants may be able to evade the protective immunity that a person has established as a result of a previous infection or immunization. The resurgence of past, more deadly options can also have a devastating effect on those whose immunity is compromised.

“Therefore, we believe that the development of a broadly protective (ideally universal) vaccine against COVID-19 is essential to keep this virus under control. In addition, reduced storage and transportation requirements at ultra-low temperatures could make the vaccine a more accessible and affordable option worldwide. We believe that the combination of features of JCXH-221 could address these needs and make it well-positioned to be a next-generation vaccine against this evolving pandemic.”

The Phase 1 portion of this study will be a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, immunogenicity, and determination of a Phase 2 recommended dose (RP2D) for JCXH-221. The Phase 2 portion will be a randomized, double-blind, active-controlled study to further characterize the safety and immunogenicity of JCXH-221 in RP2D.