On July 6, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of a review of the company’s clinical development program evaluating CMN-001, a dendritic cell-based immunotherapy electroporated with autologous tumor RNA to treat metastatic renal cell carcinoma (mRCC) (Press release, CoImmune, JUL 6, 2023, View Source [SID1234633095]). The review is published in Human Vaccines & Immunotherapeutics, a peer-reviewed journal sponsored by the International Society for Vaccines.
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"Engineering dendritic cells to treat cancer is a long sought-after goal for cell-based immunotherapies," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "CMN-001 is specifically designed to elicit an adaptive T-cell response against the antigens present in the patient’s own tumor tissue. With more than two decades of clinical experience with CMN-001, we are implementing lessons learned for a new study that reflects the changing landscape of therapies available to treat mRCC. We have an exciting opportunity to combine and sequence therapies with three distinct mechanisms of action and look forward to advancing this development program."
The publication, titled, "A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma," reviews the early clinical development of CMN-001, including a previously completed multicenter Phase 3 clinical trial that demonstrated synergy between CMN-001 and an mTOR blocker, everolimus, in a retrospective data analysis.
CoImmune has designed an ongoing randomized Phase 2b clinical trial that builds on the mechanism of action of CMN-001 and underlying immune and clinical outcomes observed. In this trial, CMN-001 is being combined with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC patients. The trial is actively recruiting with plans to enroll 90 patients.
"Clinical trials employing antigen-loaded dendritic cells have been shown to be safe and provide positive clinical benefit in small proportions of patients, and we are looking for ways to improve the overall efficacy to attain durable clinical responses," said Mark DeBenedette, Ph.D., Vice President of Research and Development of CoImmune. "Based on the surprising benefit of everolimus as a subsequent second-line therapy revealed in a retrospective analysis of more than 90 patients – a benefit that only manifested if subjects were administered CMN-001 – we have a rationale for evaluating this combination further in poor-risk mRCC patients who have limited treatment options today."