FDA Clears IND of Intravenous JCXH-211 in Advanced Solid Tumors

• The FDA has granted clearance to an investigational new drug (IND) application of intravenous (IV) JCXH-211 in patients with advanced solid tumors.
• JCXH-211 is a first-in-class, self-replicating mRNA (srRNA) encoding the engineered human interleukin (IL)-12 protein.
• With this IND, a phase 1/2 study will begin, and investigators will evaluate IV JCXH-211 for the treatment of malignant solid tumors.

The FDA has cleared the IND application of IV JCXH-211, allowing for the start of a phase 1/2, multicenter, open-label, dose-escalation and dose-expansion study for the treatment of patients with malignant solid tumors.¹

JCXH-211 is a first-in-class therapy that utilizes lipid nanoparticle encapsulated srRNA technology from Immorna and works by encoding the engineered human IL-12 protein.

In the upcoming phase 1/2 study investigators plan to evaluate the safety and tolerability of JCXH-211 given via IV infusion and determine the recommended phase 2 dose (RP2D) of the agent when given in combination with a checkpoint inhibitor (CPI). Further, the preliminary efficacy of the combination at the RP2D will be evaluated.

Tumor microenvironment concept with cancer cells, T-Cells, nanoparticles, cancer associated fibroblast layer of tumor microenvironment normal cells, molecules, and blood vessels 3d rendering: © catalin - stock.adobe.com

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

In preclinical studies and patient-derived xenograft (PDX) models, JCXH-211 has demonstrated superior tumor-eradication potency compared with conventional mRNA-based therapies. This enhanced efficacy is attributed to the antiviral innate response triggered by RNA replicon and the potent anti-cancer immunity stimulated by the engineered IL-12 protein.

Early data from a phase 1 trial (NCT05727839) of JCXH-211 showed that intratumoral injection given as a monotherapy was encouraging, demonstrating excellent safety, tolerability, and significant antitumor activity, including an abscopal effect.² If successful in additional clinical trials, JCXH-211 has the potential to become a new, readily accessible option for patients with cancer who have exhausted other treatment options.¹

“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," added Le in the press release.

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, Inc. July 8, 2024. Accessed July 8, 2024. https://tinyurl.com/39pbzrhr

2. Study to evaluate JCXH-211 as monotherapy in patients with malignant solid tumors. ClinicalTrials.gov. Accessed July 8, 2024. Updates March 20, 2023. https://clinicaltrials.gov/study/NCT05727839