JCXH-211 IT / Immorna - LARVOL DELTA

SERIL: Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Duke University | Trial completion date: Oct 2029 ➔ Oct 2030 | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor

One Trial of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Immorna Biotherapeutics, Inc.

New P1 trial • Oncology • Solid Tumor

SERIL: Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Duke University | Initiation date: Oct 2024 ➔ Feb 2025

Trial initiation date • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor

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 (PRNewswire) - "Immorna Biotherapeutics...announced today that the U.S. Food and Drug Administration (FDA) has cleared its 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 clearance allows Immorna to initiate a Phase 1/2, multi-center, open-label, dose escalation and expansion study of JCXH-211 administered intravenously in patients with malignant solid tumors. The goal of the study is to assess safety and tolerability, determine the recommended Phase 2 dose (RP2D) for JCXH-211 IV in combination with checkpoint inhibitor (CPI), and assess preliminary efficacy of the combination at the RP2D."

IND • New P1/2 trial • Solid Tumor

A phase I study to evaluate the safety and tolerability of JCXH-211 (a self-replicating mRNA encoding IL-12) intratumoral injection in patients with malignant solid tumors: Results from the phase Ia dose escalation. (ASCO 2024) - P1 | "JCXH-211 IT administration with doses of 5μg, 25μg, 50μg Q4W demonstrated good safety profile. Antitumor activities were observed in the heavily pretreated late-stage pts. Significant increases of T and NK cell infiltration were observed."

Clinical • P1 data • Anemia • Breast Cancer • Head and Neck Cancer • Hematological Disorders • Melanoma • Nasopharyngeal Carcinoma • Oncology • Sarcoma • Solid Tumor • IL12A

SERIL: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 (SElf-Replicating RNA IL-12) Intratumoral Injection in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Duke University

New P1 trial • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Intravenous administration of IL-12 encoding self-replicating RNA-lipid nanoparticle complex leads to safe and effective antitumor responses. (PubMed, Sci Rep) - "Finally, intravenous injection of JCXH-211 did not cause noticeable systemic toxicity in tumor-bearing mice and non-human primates. Thus, our study demonstrated the feasibility of intravenous administration of JCXH-211 for the treatment of advanced cancers."

IO biomarker • Journal • Oncology • Solid Tumor • IL12A

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=1 | Active, not recruiting | Sponsor: Immorna Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=144 ➔ 1

Enrollment change • Enrollment closed • Monotherapy • Oncology • Skin Cancer • Solid Tumor

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Immorna Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Skin Cancer • Solid Tumor

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Not yet recruiting | Sponsor: Immorna Biotherapeutics, Inc.

New P1 trial • Oncology • Solid Tumor

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Immorna Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Skin Cancer • Solid Tumor

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Immorna Biotherapeutics, Inc.

Monotherapy • New P1 trial • Oncology • Skin Cancer • Solid Tumor

Immorna Biotherapeutics, Inc. Receives IND Clearance to Conduct FIH Study of JCXH-211, the First-in-Class Self-replicating mRNA (PRNewswire) - "Immorna Biotherapeutics, Inc...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."

IND • Oncology • Solid Tumor