On September 26, 2024 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, reported to advance its Natural Killer (NK) cell therapy, INKmune, in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, INmune Bio, SEP 26, 2024, View Source [SID1234646878]). The Company is pleased to announce initial results from the first patient cohort in the trial.
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Mark Lowdell, CSO and inventor of INKmune, said, "The enrollment of the first cohort ran entirely in-line with our predicted timelines and confirmed the excellent safety profile with all patients receiving treatment as out-patient without the need for pre-medication of any kind. Furthermore, even at this lowest dose of INKmune, there is clear evidence of persistent immunologic effects of INKmune treatment in these men with mCRPC.
Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK cell activity and function.
The CaRe PC trial has recently completed dosing the last patients in the second of its three dose-escalation cohorts. The third cohort is expected to begin in approximately 30 days. The dose of INKmune in the second and third cohort is 3 and 5 times the dose of INKmune in the first cohort. All eight clinical sites are now open and additional results from the trial will be released from the higher dose cohorts as they become available.
About INKmune
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). INKmune treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins. INKmune is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the United States.