INmune Bio (INMB) reports that its Phase I/II trial of INKmune for men with metastatic castration-resistant prostate cancer has met its primary and secondary endpoints and is now closed to further enrollment. INKmune was well tolerated at all three dose levels in the trial, demonstrating an excellent safety profile, the primary endpoint of CaRe PC. Additionally, patients with low NK cell activation saw the greatest improvement in their biomarkers of NK cell activation, defining the target population for the next trials. Following the successful completion of the Phase 1/2 trial of INKmune in patients with advanced-stage disease, INmune Bio plans to advance the program by designing a randomized Phase 2b trial in patients with less severe disease, enabling a more robust measurement of the drug’s effects and potential clinical benefits.
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