First-in-Class Therapy JCXH-211 Shows Promise for Treating Advanced Solid Tumors

JCXH-211 is a first-in-class therapy that utilizes lipid nanoparticle encapsulated srRNA technology from Immorna and encodes the engineered human IL-12 protein. In preclinical studies and patient-derived xenograft (PDX) models, JCXH-211 has demonstrated superior tumor-eradication potency compared with conventional mRNA-based therapies.

Phase 1/2 Study of JCXH-211 and CPI Combination for Solid Tumors

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). The preliminary efficacy of the combination at the RP2D will also be evaluated. Based on data from preclinical studies, clinical data from the JCXH-211 intratumoral administration trial, and the candidate drug’s mechanism of action, IV JCXH-211 in combination with CPI has the potential to work synergistically to enhance the antitumor effect.

Fast Track Designation for 225Ac-FL-020 and Cosibelimab

The FDA has granted fast track designation to 225Ac-FL-020, a promising PSMA-targeting radionuclide drug conjugate for metastatic castration-resistant prostate cancer. The manufacturer has also resubmitted an application to the FDA for approval of the drug cosibelimab, which is being investigated for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. The tissue-based companion diagnostic device was approved for the same therapy and indication in August 2023.

Conclusion

The development of JCXH-211 offers hope for patients with advanced solid tumors who have limited treatment options. The planned phase 1/2 study evaluating the safety and efficacy of the combination of JCXH-211 and CPI will provide valuable information on the potential of this therapy to improve outcomes for this patient population. The fast track designation for 225Ac-FL-020 and cosibelimab is also encouraging news, highlighting the ongoing efforts to develop new treatments for cancer and improve patient outcomes.

Keywords:

• JCXH-211
• solid tumors
• IL-12
• lipid nanoparticle
• srRNA technology
• checkpoint inhibitor
• 225Ac-FL-020
• cosibelimab
• metastatic castration-resistant prostate cancer
• cutaneous squamous cell carcinoma

Originally Post From https://www.targetedonc.com/view/fda-clears-ind-of-intravenous-jcxh-211-in-advanced-solid-tumors

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