INmune Bio's INKmune trial meets primary and secondary endpoints for mCRPC treatment.

INmune Bio has reported that its Phase I/II trial of INKmune for metastatic castration-resistant prostate cancer (mCRPC) has met primary and secondary endpoints. The treatment was well-tolerated at all three dose levels and demonstrated an excellent safety profile. Patients with low NK cell activation saw the greatest improvement in biomarkers of NK cell activation, defining the target population for future trials.

INmune Bio Inc. (NASDAQ: INMB) has announced that its Phase I/II trial (CaRe PC) of INKmune™ for metastatic castration-resistant prostate cancer (mCRPC) has successfully met its primary and secondary endpoints. The trial, which enrolled men with mCRPC, demonstrated that INKmune™ was well-tolerated at all three dose levels and exhibited an excellent safety profile [1].

The primary endpoint of the trial was to assess the safety and tolerability of INKmune™. The treatment was found to be safe and effective in activating natural killer (NK) cells in a subset of more than half of the patients with advanced disease. Notably, patients with low NK cell activation showed the greatest improvement in biomarkers of NK cell activation, indicating that this population may be the target for future trials [1].

Dr. Mark Lowdell, Chief Scientific Officer at INmune Bio, commented, "INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease. 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" [1].

Following the successful completion of the Phase I/II trial, INmune Bio plans to advance the program by designing a randomized Phase 2b trial in patients with less severe disease. This will enable a more robust measurement of the drug's effects and potential clinical benefits [1].

INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line that conjugates to resting NK cells and delivers multiple, essential priming signals to convert the patient's resting NK cells into tumor-killing memory-like NK cells (mlNK cells). The treatment converts the patient's own NK cells into mlNK cells, which have persisted for more than 100 days in patients. These cells function in the hypoxic tumor microenvironment (TME) due to upregulated nutrient receptors and mitochondrial survival proteins [1].

INKmune™ is a patient-friendly drug treatment that does not require pre-medication, conditioning, or additional cytokine therapy. It is easily transported, stored, and delivered to the patient by a simple intravenous infusion as an outpatient. INKmune™ is tumor-agnostic and can be used to treat various types of NK-resistant tumors, including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal, and nasopharyngeal cancer [1].

INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The company has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform, the Natural Killer Cell Priming Platform, which includes INKmune®, and CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal stromal/stem cell (hucMSCs) platform [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/04/3126499/0/en/INmune-Bio-s-CaRe-PC-Trial-of-INKmune-in-Metastatic-Castration-Resistant-Prostate-Cancer-Meets-Endpoints-and-Is-Closed-to-Enrollment.html