Phase 1/2 Trial of INKmune™ Begins with First Patient in Metastatic Castration-Resistant Prostate Cancer

INmune Bio, a company specializing in clinical-stage immunology, has initiated a Phase I/II trial for a new biologic therapy called INKmune™. The treatment is designed to target and enhance the function of a patient's natural killer (NK) cells, which are a key component of the innate immune system. The therapy is administered as an outpatient intravenous infusion, eliminating the need for pre-medication or cytokine support.

The trial, known as CaRe PC, will involve up to 30 male participants with metastatic castration-resistant prostate cancer (mCRPC). They will receive varying doses of INKmune™, with the treatment being administered three times within the first two weeks. The patients will then be monitored for six months to evaluate the therapy's impact on their immune response and its effectiveness against cancer.

The study will focus on changes in the number of memory-like NK cells in the blood and the duration of their presence in circulation. Additionally, the level of prostatic surface antigen (PSA) will be tracked, along with the use of Artificial Intelligence (AI) to assess the number and size of metastatic lesions. This will be done using piflufolastat F 18, a PSMA imaging agent, and by measuring circulating tumor DNA (ctDNA).

Prof. Mark Lowdell, Chief Scientific Officer of INmune Bio and the inventor of INKmune™, emphasized the importance of having immune cells in the tumor and the drug's ability to activate these cells to fight cancer. He believes that INKmune™ has the potential to convert resting NK cells into memory-like cells capable of attacking tumors.

The clinical trial employs a novel Bayesian design, with a sequential Phase I dose escalation followed by a simultaneous Phase II trial across all dosing cohorts. The goal is to establish the safety of INKmune™ and to identify the optimal dosage for future clinical trials based on the immunologic and anti-tumor responses observed.

INKmune™ is a patented therapy that uses a human tumor cell line to deliver essential priming signals to resting NK cells, similar to the effect of multiple cytokines. It is stable at -80°C and administered via IV infusion. The therapy aims to enhance the binding of NK cells to tumor cells, particularly those resistant to standard NK-mediated lysis. INKmune™ has the potential to target a wide range of tumors, including those that are resistant to conventional treatments.

INmune Bio is a publicly traded company (NASDAQ: INMB) that is developing treatments targeting the innate immune system. The company has two product platforms in clinical trials: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform and the Natural Killer Cell Priming Platform, which includes INKmune™. These platforms are designed to treat various malignancies and chronic inflammation through a precision medicine approach.