RALEIGH, NC, USA I March 28, 2022 I Immorna Biotherapeutics, Inc. (Immorna), a rapidly-expanding biotechnology company developing both self-replicating and conventional mRNA-based therapeutics and vaccines, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for JCXH-211, a novel self-replicating mRNA encoding human interleukin (IL)-12 protein.

This IND clearance allows Immorna to initiate a Phase 1, multi-center, open-label, First-in-Human (FIH) dose escalation and expansion study of JCXH-211 in patients with malignant solid tumors, administered via intratumoral injection. The goal of the study is to establish a recommended dosing regimen, and assess the safety, tolerability and preliminary efficacy of JCXH-211 in cancer patients.

JCXH-211 is the first-in-class lipid nanoparticle (LNP) encapsulated self-replicating mRNA, using Immorna’s proprietary technology, encoding the human IL-12 protein. The strong anti-viral innate response triggered by RNA replicon together with the potent anti-cancer immunity stimulated by IL-12 conferred JCXH-211 superior tumor-eradicating potency in multiple preclinical animal and patient-derived xenograft (PDX) models, which was better than similar investigational drug employing conventional (non-replicating) mRNA. JCXH-211 was manufactured by Immorna’s robust CMC process and showed very favorable safety profiles in comprehensive GLP toxicology studies.

IL-12 is a naturally occurring cytokine that plays a key role in the body’s immune response against cancer. Despite consistently showing potent antitumor activity in preclinical studies, the efficacy of IL-12 treatment at tolerable doses in humans failed to provide clinical benefit. One key challenge for IL-12 treatment is the delivery method. IL-12 given through bolus injection was unstable and had a short half-life, and frequent intravenous administration of recombinant human IL-12 protein was challenging due to unacceptable toxicities. Alternate localized delivery systems, such as intratumoral injection, could potentially help to overcome this hurdle by directly targeting the tumor microenvironment whilst limiting systemic exposure and thereby minimizing adverse effects.

“IL-12 is crucially important in providing the immune antitumor response,” said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. “Immorna is excited to have received FDA clearance to initiate this FIH study of JCXH-211, the first-in-class LNP-encapsulated self-replicating mRNA encoding human IL-12 protein, in patients with malignant solid tumors. We look forward to working with the investigators and patients to bring this potential novel therapy to patients who are in dire need of new and effective treatments.”

“Our RNA encodes innovation. With this IND clearance, we are thrilled that Immorna is now transitioning into a clinical-stage biotech,” said Zihao Wang, Ph.D., Co-Founder and Chief Executive Officer of Immorna. “Since its founding, Immorna has established robust processes that can efficiently and consistently produce high quality and potent cell-replicating as well as conventional mRNA. Immorna has also developed an arsenal of mRNA delivery vehicles, including thermal-stable ones. This IND clearance of JCXH-211 marks Immorna’s first Oncology investigational drug to be tested in humans and, more importantly, FDA’s acceptance of our mRNA platform technology. We expect to bring more potentially life-saving drugs and vaccines to the clinic in the near future.” 

About Immorna

Immorna is a rapidly-expanding biotech company that focuses on developing self-replicating and conventional mRNA-based therapeutics and vaccines. Since its founding in 2019, Immorna has built a robust CMC platform for mRNA 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 mRNA 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 mRNA development pipeline spanning cancer immunotherapy, infectious diseases, rare genetic diseases, and medical cosmetology, and quickly advancing its oncology and infectious disease drug candidates into their clinical stages.

SOURCE: Immorna