Phase 1/2 trial of INKmune therapy for mCRPC meets primary end point

The phase 1/2 CaRe PC trial (NCT06056791) assessing INKmune in patients with metastatic castration-resistant prostate cancer (mCRPC) has met its primary and secondary end points, INmune Bio reported in a news release.¹

The company also reported that the CaRe PC trial is now closed to further enrollment.

According to the company, “INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells).”

In the study, INKmune demonstrated a favorable safety profile and was well-tolerated across all 3 dose levels assessed, thus reaching the primary end point of the trial.

Data also showed that “patients with low NK cell activation saw the greatest improvement in their biomarkers of NK cell activation,” INmune reported. According to the company, this finding helps to define the target population for future trials.

“INKmune was safe and effective at activating NK cells in a subset of more than half of these patients with advanced disease,” said Mark Lowdell, PhD, Chief Scientific Officer and Chief Manufacturing Officer at INmune Bio, in the news release.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.”

Following final completion of the CaRe PC trial, INmune plans to launch a randomized phase 2b trial of INKmune in patients with less severe disease, thus “enabling a more robust measurement of the drug's effects and potential clinical benefits,” the company noted.

About the CaRe PC trial

In total, the open-label, phase 1/2 trial planned to enroll up to 30 patients with mCRPC through clinical trial sites across the US.² To be eligible for enrollment, patients needed to have a prostate-specific antigen level greater than 1.0 ng/mL at baseline, an ECOG performance score of 0 to 1, castrate levels of testosterone (less than 50 ng/dL), and adequate organ function.

Overall, the trial is assessing the safety and anti-tumor activity of INKmune across 3 dose levels. Patients in the trial received up to 3 infusions of INKmune (given on days 1, 8, and 15) at a dose level of either low (1 x 10⁸ cells per infusion), medium (3 x 10⁸ cells per infusion), or high (5 x 10⁸ cells per infusion). Patients are then followed for 6 months to assess immunologic and anti-cancer responses to INKmune therapy.³

The primary goals of the study are to evaluate the safety of INKmune in patients with mCRPC and to determine a recommended dose level to be used in a blinded, randomized registration trial.

Final completion of the CaRePC trial is expected in November 2025.

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, Inc. August 4, 2025. Accessed August 4, 2025. https://www.inmunebio.com/index.php/newsroom/2025-news/muneiosaerialofmuneinetastaticas20250804050503

2. Study of INKmune in patients with mCRPC (CaRe Prostate) (CaRe). ClinicalTrials.gov. Last updated May 13, 2025. Accessed August 4, 2025. https://clinicaltrials.gov/study/NCT06056791

3. INmune Bio Inc. expands INKmune trial in prostate cancer to veterans. News release. INmune Bio, Inc. January 28, 2025. Accessed August 4, 2025. https://www.inmunebio.com/index.php/newsroom/2025-news/muneioncxpandsmunerialinrostateancerto20250128050502