A recent Phase 1/2 clinical trial evaluating INKmune, an investigational immunotherapy, in men with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary endpoints, demonstrating a favorable safety profile and signs of biological activity.

The CaRe PC trial  assessed the safety, tolerability, and preliminary efficacy of INKmune administered at three dose levels in patients with advanced mCRPC. INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line designed to prime resting natural killer (NK) cells and transform them into memory-like NK cells capable of effectively targeting tumor cells.

The study enrolled up to 30 patients across multiple sites in the United States. Eligible participants included men with progressive mCRPC, prostate-specific antigen (PSA) levels greater than 1.0 ng/mL, castrate testosterone levels below 50 ng/dL, and good performance status. Patients received up to three intravenous infusions of INKmune at low, medium, or high dose levels within a single month, followed by six months of monitoring for immunologic and clinical responses.

Results showed that INKmune was well tolerated across all dose levels, achieving the primary endpoint of safety with no significant adverse events attributed to the therapy. Importantly, biomarker analyses revealed effective activation of NK cells in a subset of more than half the treated patients, most notably in those with low baseline NK cell activation. This observation helped to identify a target population that may derive the greatest benefit from INKmune treatment.

Although the trial was not primarily designed to assess efficacy, some participants exhibited reductions in tumor lesion size, with a few lesions disappearing altogether during therapy. These findings suggest potential direct antitumor effects driven by the activated NK cells.

Encouraged by these results, the sponsoring company plans to advance INKmune into a randomized Phase 2b trial involving patients with less severe disease.

Source.