INmune Bio Inc. Completes First Cohort and Initiates Second Cohort of Phase 1/2 Study of INKmune Natural Killer Cell Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Boca Raton, Florida, April 29, 2024 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, continues to advance its Natural Killer (NK) cell therapy, INKmune, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the successful completion of the first cohort in the trial. Following review by the Safety Review Committee (SRC), approval has been granted to proceed with the second dose level (cohort 2). The first patient of the second cohort has been identified and will undergo screening to prepare for treatment.

So far, there have been 9 administrations of INKmune in the mCRPC study given as an out-patient with no significant adverse events. When added to the experience with INKmune given in the MDS/AML trial, over 20 infusions of INKmune have been given safely without the need for conditioning therapy, pre-medication, or cytokine support. 

“We are pleased with the safety of INKmune in men with mCRPC and feedback from the SRC to proceed with cohort 2. Our initial focus is on assessing the safety of INKmune in this group of patients, and the fact that the drug can be safely administered on an outpatient basis is appealing to both patients and clinical teams. Safety is just one aspect of the therapeutic process. The main objective of INKmune therapy is to transform resting NK cells into memory-like NK cells capable of attacking the tumor. Given that prostate cancer has numerous resting NK cells in the tumor microenvironment (TME) that do not eliminate cancer, we believe that INKmune, by transforming the patient’s NK cells into cancer-killing cells, could potentially be an optimal therapy for prostate cancer,” said Prof. Mark Lowdell Ph.D., CSO of INmune Bio and inventor of INKmune.

About CaRe PC

CaRe PC is an open label Phase I/II trial that will test up to three doses of INKmune in men with mCRPC. INKmune is given in the out-patient setting via an intravenous infusion three times in the first two weeks of treatment (days 1, 8 and 15). No pre-medication or additional cytokines are needed for INKmune therapy. The patient is followed for six months with careful study of immunologic and anti-cancer responses to INKmune treatment. Immune responses include changes in numbers of tumor killing memory-like NK cells in the patient’s blood and how long these specialized NK cells remain in the circulation. Anti-tumor responses will be monitored by following the level of prostatic surface antigen (PSA) in the blood. Additionally, we will leverage Artificial Intelligence (AI) to quantify the number and size of metastatic lesions using piflufolastat F 18 - a PSMA (prostate-specific membrane antigen) imaging agent developed by Lantheus marketed as Plarify, and by measuring circulating tumor DNA (ctDNA) in the blood. Up to 30 patients will receive one of three levels of dose of INKmune (low, medium, high).