Pharma Focus America

Immorna Biotherapeutics Receives U.S. FDA Clearance for Phase 1/2 Study of JCXH-211 IV in Advanced Solid Tumors, as Monotherapy and in Combination with Checkpoint Inhibitor

Monday, July 08, 2024

Immorna Biotherapeutics, Inc. (Immorna), a biotechnology firm in the clinical stages, has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for JCXH-211 intravenous (IV). This novel therapy involves a self-replicating mRNA (srRNA) encoding an engineered form of human interleukin-12 (IL-12) protein.

The clearance enables Immorna to initiate a Phase 1/2 study across multiple centers. This study, open-label in nature, will involve dose escalation and expansion to assess the safety, tolerability, and determine the recommended Phase 2 dose (RP2D) of JCXH-211 IV in combination with a checkpoint inhibitor (CPI). Additionally, the study aims to evaluate the preliminary efficacy of this combination therapy in patients with malignant solid tumors.

Immorna, expressed enthusiasm about this milestone, stating, "We are thrilled to achieve this significant milestone for one of our key assets. Based on our preclinical and clinical data from the JCXH-211 intratumoral administration trial, and the unique mechanism of action of this candidate, we believe that JCXH-211 IV, when combined with a CPI, has the potential to synergistically enhance anti-tumor effects. We eagerly anticipate collaborating with investigators and patients to bring this promising therapy to those in urgent need of new treatment options."

JCXH-211 utilizes lipid nanoparticle (LNP) technology to encapsulate srRNA, leveraging Immorna's proprietary technology to encode the engineered human IL-12 protein. Preclinical studies in animal models and patient-derived xenografts (PDX) have demonstrated that JCXH-211's combination of RNA replicon-induced antiviral innate responses and IL-12-mediated potent anti-cancer immunity outperforms similar candidates employing conventional mRNA. Early results from a Phase 1 trial evaluating JCXH-211 IT as monotherapy have shown excellent safety, tolerability, and significant anti-tumor effects, including the abscopal effect.

IL-12 is a natural cytokine critical in the body's immune response against cancer. Despite its potent anti-tumor activity in preclinical studies, recombinant IL-12 protein treatments at tolerable doses have not translated into clinical benefits in humans. Challenges include the narrow therapeutic window and short half-life of recombinant IL-12, necessitating frequent intravenous administration and causing unacceptable toxicities. JCXH-211 IV, with its srRNA technology, allows prolonged IL-12 expression primarily in tumor tissues, modifying the tumor microenvironment and activating anti-tumor immune responses while minimizing systemic toxicity. Nonclinical studies in rodents and non-human primates have demonstrated JCXH-211 IV's excellent safety profile. Successful outcomes may position JCXH-211 IV as a potentially life-saving and readily accessible therapy for cancer patients who have exhausted or become resistant to current treatments.



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