Phase 1/2 NK Cell Therapy Study: INmune Bio Advances to Second Cohort for Prostate Cancer Patients

INmune Bio, a clinical-stage immunology company, is advancing its NK cell therapy, INKmune™, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer (mCRPC). The first cohort of the trial has been successfully completed, and the Safety Review Committee (SRC) has granted approval to proceed with the second dose level. The first patient of the second cohort has been identified and will undergo screening.

The NK cell therapy has been administered nine times in the mCRPC study without any significant adverse events. The therapy aims to transform resting NK cells into memory-like NK cells capable of attacking the tumor. INKmune™ is a patented, pharmaceutical-grade product that conjugates to resting NK cells and delivers multiple priming signals, enhancing their ability to bind to and destroy tumor cells. The therapy does not require conditioning, pre-medication, or cytokine support.

The CaRe PC trial is testing up to three doses of INKmune™ in men with mCRPC. The treatment is administered via intravenous infusion three times in the first two weeks, with no pre-medication or additional cytokines needed. The patient's immune and anti-cancer responses are monitored for six months, including changes in the number of tumor-killing memory-like NK cells and levels of prostatic surface antigen (PSA) in the blood. Artificial Intelligence (AI) is utilized to quantify the number and size of metastatic lesions and to measure circulating tumor DNA (ctDNA).

The study employs a novel modified Bayesian design for dose escalation. The Phase I portion will determine safe doses, which will then be tested in the Phase II portion. Up to 30 patients will receive one of three levels of INKmune™ dose. The primary goals are to demonstrate the safety of INKmune™ and to determine the optimal dose for future clinical trials.

INmune Bio has manufactured all planned doses of INKmune™ for the Phase 1 study, with assays qualified to Phase 2 standard. The company is planning for BLA-standard validation in 2025. INmune Bio is a publicly traded biotechnology company focused on developing treatments targeting the innate immune system. It has two product platforms in clinical trials, including the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform and the Natural Killer Cell Priming Platform, which includes INKmune™.

The company's product platforms aim to treat a variety of hematologic and solid tumor malignancies, as well as chronic inflammation, using a precision medicine approach. For more information, visit www.inmunebio.com.