Business
INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in Patients with Metastatic Castration-Resistant Prostate Cancer
Boca Raton, Florida, Jan. 02, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on
About this update from Inmune Bio Inc.
[{"type":"text","content":"Boca Raton, Florida, Jan. 02, 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, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023. INKmune™ is a biologic therapy given as out-patient therapy without the need for pre-medication or cytokine support. “Results of immunotherapy trials for mCRPC have been disappointing,” said Professor Matt Rettig, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer Center. “After many failures using T-cell focused immunotherapy approaches, targeting NK cells -- which are abundant in the prostate cancer tumor microenvironment -- is a promising and novel strategy. I am optimistic about the therapeutic potential of INKmune, an off-the-shelf innate immune therapy.” Professor Rettig was deeply involved in the design of the clinical trial. Dr. Rettig’s statements should not be construed as endorsement by the University of California. 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 as out-patient therapy via intravenous infusion three times in the first two weeks of treatment (days 1, 8 and 15). 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, as well as using 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, and by measuring circulating tumor DNA (ctDNA) in the blood. As many as 30 patients will receive one of three levels of dose of INKmune™ (low, medium, high). “There are two key elements for successful immunotherapy. There must be immune cells in the tumor and the drug must con...