Immorna Biotherapeutics, Inc., a China-based clinical stage biotechnology company, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application for JCXH-211 intravenous (IV), a novel, first-in-class self-replicating mRNA (srRNA) encoding the engineered human interleukin (IL)-12 protein.

The IND approval enables the company to commence a Phase 1/2, multi-centre, open-label, dose escalation and expansion study of JCXH-211, administered intravenously in patients with malignant solid tumours.

The aim of the study is to evaluate the safety and tolerability, and to determine the recommended Phase two dose (RP2D) for JCXH-211 IV along with checkpoint inhibitor (CPI), and to evaluate preliminary efficacy of the combination at the RP2D.

The product is a first-in-class lipid nanoparticle (LNP) encapsulated srRNA, utilising Immorna's proprietary technology, encoding the engineered human IL-12 protein.