DENVER, Colo., Aug 04, 2025 (247marketnews.com)- INmune Bio’s (NASDAQ:INMB) Phase I/II clinical trial of INKmune, the CaRe PC trial, in patients with metastatic castration-resistant prostate cancer (mCRPC) has successfully met its primary and secondary endpoints and is now closed to further enrollment.
The CaRe PC trial evaluated the safety, tolerability, and biological activity of INKmune in men with advanced prostate cancer. The study demonstrated that INKmune was well tolerated across all three dose levels, achieving the trial’s primary endpoint of safety.
In addition to its strong safety profile, the trial met its secondary endpoints. Patients with low baseline natural killer (NK) cell activation showed the most pronounced improvements in biomarkers of NK cell activity, identifying a clear target population for subsequent trials.
Dr. Mark Lowdell, INmune Bio’s Chief Scientific Officer, stated, “Excitingly we did see, in some patients, individual tumor lesions either reducing in size or completely disappearing during treatment, so we believe this could be evidence of a direct effect on tumor cell killing.”
INmune Bio plans to advance INKmune into a randomized Phase 2b trial, focused on patients with less advanced disease, to more robustly assess clinical efficacy and therapeutic impact in a more controlled setting.
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