INmune Bio's INKmune Hits End Points in mCR Prostate Cancer Trial
INmune Bio reported that INKmune was well-tolerated at the 3 dose level used in the trial.
Matt Rettig, MD
INmune Bio's open-label phase 1/2 CaRe PC clinical trial (NCT06056791), which is evaluating its cell therapy INKmune for the treatment of metastatic castration-resistant prostate cancer (mCRPC), has met its primary and secondary end points. The company additionally noted that the trial is no longer enrolling new patients.1
INKmune consists of a pharmaceutical-grade, replication-incompetent human tumor cell line that is intended to conjugate resting natural killer (NK) cells to turn them into memory-like NK cells (mlNK cells) that kill tumor cells, by means of essential priming signals. Notably, conditioning and premedication are not needed before administration of INKmune, which is conducted by intravenous infusion in an outpatient setting.
The primary end point of CaRe PC is the therapy’s safety profile, and INmune Bio reported that INKmune was well-tolerated at the 3 dose levels used in the trial. The company characterized the therapy’s safety profile as “excellent.” INmune also pointed out that the greatest improvement in biomarkers of NK cell activation was observed in patients with low NK cell activation. As a result of this, INmune stated that this will be the population targeted with the therapy in future clinical trials.
“INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease,” Mark Lowdell, PhD, the chief scientific officer at INmune Bio, said in a statement.1 “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 additionally stated that after CaRe PC, which includes patients with advanced-stage disease, is finished, it intends to design a randomized phase 2b clinical trial that will evaluate INKmune in patients with less severe disease. The company expects that this will allow for INKmune’s potential clinical benefits and effects to be assessed in a more robust manner. According to INmune, INKmune is also tumor agnostic and may be able to be used to treat range of different cancer types that are NK-resistant, with leukemia, lymphoma, myeloma, lung, ovarian, breast, renal, and nasopharyngeal cancer listed as examples. The company also notes that tumor-killing NK cells primed by INKmune have shown the ability to persist in patients for over 100 days.
The dosing of the first patient in CaRe PC was originally reported in January 2024.2 The trial’s 3 dose levels for INKmune were 1x108 cells, 3x108 cells, and 5x108 cells. The therapy was delivered through infusions on days 1, 8, and 15 of the study, and patients were followed for 6 months posttreatment. Notably, in October 2023, INmune received a favorable patentability opinion on INKmune, also known as INB16, from an examiner from the International Search Authority at the United States Patent & Trademark Office.3
“Results of immunotherapy trials for mCRPC have been disappointing,” investigator Matt Rettig, MD, a professor of medicine and urology and medical director of the Prostate Cancer Program at David Geffen School of Medicine, UCLA, and a member of Jonsson Comprehensive Cancer Center, said in a January 2024 statement.2 “After many failures using T-cell focused immunotherapy approaches, targeting natural killer cells—which are abundant in the prostate cancer tumor microenvironment—is a promising and novel strategy. I am optimistic about the therapeutic potential of INKmune, an off-the-shelf innate immune therapy.”
REFERENCES
1. INmune Bio’s CaRe PC trial of INKmune in metastatic castration-resistant prostate cancer meets endpoints and is closed to enrollment. News release. INmune Bio. August 4, 2025. Accessed August 5, 2025. https://www.inmunebio.com/index.php/newsroom/2025-news/muneiosaerialofmuneinetastaticas20250804050503
2. INmune Bio announces first patient dosed in a phase 1/2 study of INKmune in patients with metastatic castration-resistant prostate cancer. News release. INmune Bio. January 2, 2024. Accessed August 5, 2025. https://www.globenewswire.com/news-release/2024/01/02/2802613/0/en/INmune-Bio-Announces-First-Patient-Dosed-in-a-Phase-1-2-Study-of-INKmune-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer.html
3. INmune Bio Inc. patent claims covering INB16 cell line and INKmune therapeutic composition given Favorable Patentability Opinion by International Search Authority. News release. Inmune Bio. October 31, 2023. Accessed August 5, 2025. https://www.inmunebio.com/news-2/2023/543-muneioncatentlaimsovering16ellineand20231031
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