Phase I/II Clinical Trial of JCXH-211 IV to Begin Following FDA Investigational New Drug Clearance

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The FDA has cleared Immorna Biotherapeutics’ Investigational New Drug Application (IND) for JCXH-211 intravenous (IV), a novel, first-in-class self-replicating mRNA (srRNA) encoding the engineered human interleukin (IL)-12 protein. The IND clearance allows Immorna to initiate a Phase I/II clinical trial evaluating the potential therapy in patients with malignant solid tumors.¹

The trial will be a multi-center, open-label, dose escalation and expansion study of JCXH-211 administered intravenously. According to Immorna, the goal of the study is to assess safety and tolerability, determine the recommended Phase II dose (RP2D) for JCXH-211 IV in combination with checkpoint inhibitor (CPI), and assess preliminary efficacy of the combination at the RP2D.

JCXH-211 is a lipid nanoparticle (LNP) encapsulated self-replicating mRNA (srRNA) which uses Immorna's proprietary technology, encoding the engineered human IL-12 protein.

"We are excited to have achieved this important milestone for one of our key assets," NgocDiep Le, MD, PhD, president and global chief medical officer of Immorna said in a press release. Based on data from our preclinical studies, clinical data from our JCXH-211 intratumoral administration (IT) trial, and the candidate drug's mechanism of action, we believe JCXH-211 IV in combination with CPI has the potential to work synergistically to enhance anti-tumor effect. 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."

Earlier in June, Immorna presented clinical data from its JCXH-211 clinical trials (NCT05727839) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.²

In an earlier press release, Le said: “JCXH-211 induces strong anti-tumor activities through multiple mechanisms of action: the potent anti-tumor activity of IL-12 and the strong immune stimulating capability of srRNA, which modulates the tumor microenvironment and turns a ‘cold’ tumor into an inflammatory ‘hot’ tumor. In the Phase Ia dose escalation study where JCXH-211 monotherapy is given intratumorally, JCXH-211 demonstrates an excellent safety and tolerability profile without dose-limiting toxicity (DLT) and strong biological activities as evidenced by robust immune cell tumor infiltration and levels of tumor growth control and/or shrinkages in the JCXH-211 monotherapy setting. The encouraging data warrant further clinical development. We look forward to initiating the JCXH-211 combination therapy trial with a CPI. In the meanwhile, based on the differential and selective expression of srRNA in tumor tissues, we have submitted the IND application of JCXH-211 intravenous administration trial with a study design focusing on combination with a CPI. Finally, we would like to thank the patients and their families for participating in our trials, and our principal investigators and their teams for running these trials.”

The study had two main phases—Phase Ia and Phase Ib. The first stage of Phase Ia focused on skin/subcutaneous lesions and the second stage focused on deep (visceral) lesions.³

References

1. Immorna Biotherapeutics Receives U.S. FDA IND Clearance to Conduct Phase 1/2 Study of JCXH-211 IV as Monotherapy and in Combination with Checkpoint Inhibitor in Patients with Advanced Solid Tumors. News release. Immorna Biotherapeutics. July 8, 2024. Accessed July 8, 2024. https://www.prnewswire.com/news-releases/immorna-biotherapeutics-receives-us-fda-ind-clearance-to-conduct-phase-12-study-of-jcxh-211-iv-as-monotherapy-and-in-combination-with-checkpoint-inhibitor-in-patients-with-advanced-solid-tumors-302190627.html

2. Immorna Biotherapeutics Presents Clinical Data for JCXH-211, a Self-Replicating RNA Encoding the Human IL-12, at ASCO 2024. News release. Immorna Biotherapeutics. June 1, 2024. Accessed July 8, 2024. https://www.immorna.com/investors-detail-228.html

3. Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors. ClinicalTrials.gov. Accessed July 8, 2024. https://clinicaltrials.gov/study/NCT05727839