INKmune Exhibits Favorable Safety in Metastatic CRPC
Developers plan to initiate a phase 2b trial in patients with less severe prostate cancer variants to better assess INKmune’s antitumor effects.
Patients with low natural killer (NK) cell activation experienced the greatest improvement in their biomarkers of NK cell activation.
The phase 1/2 CaRe PC trial (NCT06056791), which is evaluating INKmune™ in men with metastatic castration-resistant prostate cancer (CRPC), has met its primary end point of safety and tolerability in this patient population, according to a news release from the drug’s developer, INmune Bio.1
According to the release, the investigational therapy was well tolerated across 3 escalating dose levels: 1 x 108, 3 x 108, and 5 x 108 cells per infusion, and it exhibited a favorable safety profile in patients with metastatic CRPC.2 Additionally, patients with low natural killer (NK) cell activation experienced the greatest improvement in their biomarkers of NK cell activation. According to developers, this defined the target population for future trials assessing the drug.
Furthermore, the developers plan to design a phase 2b trial in patients with less severe prostate cancer variants to better assess INKmune’s antitumor effects and clinical benefit. The phase 1/2 CaRe PC trial is currently closed for further enrollment.
“INKmune was safe and effective at activating NK cells in a subset of more than half of patients with advanced [metastatic CRPC],” Mark Lowdell, PhD, FRCPath, FRSB, chief scientific officer at INmune Bio, said 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.”
Patients in the phase 1 dose-escalation portion of the study received INKmune at 3 dose levels intravenously over 3 doses.2 Each infusion was given at least 1 week apart over a minimum 2-week period. Those in the dose-expansion portion of the study received up to 2 candidate optimal dose levels following Bayesian Optimal Interval (BOIN) termination and maximum tolerated dose (MTD) identification for final optimal dose determination.
Following dosing with INKmune, patients were present on site on days 29, 57, 85, 113, and 141 of study treatment for follow-up. On day 169, the last study visit, the option to enroll in a follow-up registry was presented to patients.
The primary end points of the study include determination of the optimal INKmune therapy dose, as well as safety and tolerability. Secondary end points include overall clinical efficacy utilizing RECIST v1.1 criteria and prostate-specific antigens (PSAs), as well as overall response rate, overall survival, disease control rate, and progression-free survival.
Developers engineered INKmune as a pharmaceutical-grade, replication-incompetent human tumor cell line. The agent conjugates to resting NK cells and delivers priming signals to convert resting NK cells into tumor killing memory-like NK cells, which function in the tumor microenvironment due to upregulated nutrient receptors and mitochondrial survival proteins.
Men 18 years and older with a blood PSA level of more than 1.0 ng/mL at the time of screening, an ECOG performance score of 0 to 1, and histologically confirmed progressive metastatic CRPC were eligible for trial enrollment. Additionally, eligible patients included those with a castrate level of testosterone of less than 50 ng/dL, adequate organ function, and a negative screening for HIV.
Patients were ineligible for enrollment if they had a diagnosis of small cell/neuroendocrine prostate cancer, a history of concurrent malignancy within 3 years of trial initiation, or an uncontrolled autoimmune disorder. Additional exclusion criteria included those with significant cardiac disease or severe debilitating pulmonary disease; clinically significant, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, gastroenterological, or neurological disease; and those who have received cytotoxic chemotherapy within 3 weeks of study treatment.
References
- 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 4, 2025. https://tinyurl.com/3sktpscd
- Study of INKmune in patients with mCRPC (CaRe Prostate) (CaRe). ClinicalTrials.gov. Updated May 13, 2025. Accessed August 4, 2025. https://tinyurl.com/a3sram3n
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