INKmune™ Shows Promising Results in NK-Cell Therapy Trials
INKmune™ Shows Major Advances in Clinical Trials
INmune Bio Inc. (NASDAQ: INMB), a pioneering company in immunology and inflammation therapies, is thrilled to report significant developments in its innovative Natural Killer (NK) cell therapy, INKmune™, as part of its ongoing Phase I/II clinical trial for men battling metastatic Castration-Resistant Prostate Cancer (mCRPC). The findings from the initial patient cohort are encouraging, showcasing both safety and increased NK-cell activity.
Positive Safety Profile Confirmed in Initial Cohort
According to Mark Lowdell, the Chief Scientific Officer and inventor of INKmune™, the enrollment process for the initial cohort of the trial proceeded flawlessly, aligning with projected timelines. Remarkably, all participants received treatment as out-patients without the necessity for pre-medication, indicating an impressive safety profile for INKmune™.
Immunologic Effects Observed
The preliminary analysis of blood samples from the first three patients highlighted notable changes in the NK cell functions and phenotypes, pinpointing the efficacy of the treatment even at the lowest administered dose. Specifically, two out of the three patients exhibited elevated levels of activated NK cells, and all three demonstrated enhanced NK cell functionality, which was sustained for over 40 days following the final infusion of INKmune™. One patient even recorded a transient 21% decrease in PSA levels, correlating with the uptick in NK cell activity.
Progressing to Next Phases in the CaRe PC Trial
The CaRe PC trial has reached a crucial juncture, concluding the dosing for the last participants in its second dose-escalation cohort. Preparations are underway to initiate the third cohort in approximately 30 days, with doses of INKmune™ in this phase expected to be three to five times greater than those used in the initial cohort. With all eight clinical sites operational, INmune Bio is poised to share additional trial results for the higher dose cohorts as they emerge.
Understanding INKmune™
INKmune™ is characterized as a pharmaceutical-grade, replication-incompetent human tumor cell line that conjugates with resting NK cells. This process effectively primes the patient’s NK cells into tumor-killing memory-like NK cells (mlNK cells). Impressively, these primed NK cells have demonstrated persistence beyond 100 days, enabling them to function effectively even in challenging tumor microenvironments.
Applications and Patient Experience
This patient-friendly therapy does not require pre-medication or additional cytokine treatments, which simplifies the treatment experience. INKmune™ is versatile, capped for general use against a wide range of NK-resistant tumors, including leukemia, lymphoma, myeloma, and other cancers. Currently, INKmune™ is being administered in an open-label Phase I/II trial targeting metastatic castration-resistant prostate cancer in the United States.
About INmune Bio Inc.
Operating as a clinical-stage biotechnology company, INmune Bio Inc. (NASDAQ: INMB) is dedicated to developing cutting-edge treatments that engage the innate immune system in combating various diseases. With two robust product platforms in clinical trials, INmune Bio utilizes advanced technologies aimed at neutralizing factors contributing to innate immune dysfunction.
The first platform is focused on the Dominant-Negative Tumor Necrosis Factor (DN-TNF), which employs innovative methods to inhibit soluble TNF, a substance linked to numerous diseases. Alongside INKmune™, the company is advancing its product candidates, including INB03™ for cancer, XPro™ for Early Alzheimer's Disease, and other conditions. The development strategy is guided by precision medicine, aiming to address a broad spectrum of hematologic and solid tumor malignancies as well as chronic inflammatory disorders.
Frequently Asked Questions
What is INKmune™ used for?
INKmune™ is an NK cell therapy designed to enhance the function of a patient’s natural killer cells to target and eliminate tumors.
How has INKmune™ performed in clinical trials?
Initial results from the first dosing cohort indicate an excellent safety profile and increased NK cell activity among participants.
What types of cancer can INKmune™ treat?
INKmune™ is applicable in treating various NK-resistant tumors, including prostate cancer, leukemia, and lymphoma.
Where is INmune Bio located?
INmune Bio operates out of Boca Raton, Florida, focusing on innovative immunological therapies.
Who can participate in the CaRe PC trial?
The trial enrolls men diagnosed with metastatic castration-resistant prostate cancer to assess the safety and efficacy of INKmune™.
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