First Patient With mCR Prostate Cancer Receives NK-Engaging INKmune

Matt Rettig, MD

INmune Bio has dosed the first patient with metastatic castration-resistant prostate cancer (mCRPC) with INKmune in the CaRe ProstateCancer (PC) phase 1/2 clinical trial (NCT06056791).¹

“Results of immunotherapy trials for mCRPC have been disappointing,” investigator Matt Rettig, MD, Professor of Medicine and Urology, Medical Director, Prostate Cancer Program, David Geffen School of Medicine,UCLA and member, Jonsson Comprehensive Cancer Center, said in a statement.¹ “After many failures using T-cell focused immunotherapy approaches, targeting natural killer 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.”

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line. It is designed to conjugate to resting natural killer (NK) cells and deliver multiple signals to prime the NK cells, which the company states issimilar to treatment with at least 3 cytokines in combination. INKmune™is given as outpatient therapy and does not require premedication or cytokine support.

CaRe PC is an open label trial that will test up to 3 doses of 3 dose levels (1x10^8, 3x10^8 or 5x10^8 cells) of INKmune™ in men with mCRPC. INKmune will be administered in the outpatient setting with 3 intravenous infusions on days 1, 8, and 15. Patients will then be followed for 6 months. The phase 1 dose escalation portion will be followed by a phase 2 portion that will enroll patients in all dosing cohorts.

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The study is primarily assessing INKmune’s safety, followed by selecting a dose for a blinded, randomized registration trial. To this end, the study will assess immune responses, including changes in numbers of tumor killing memory-like NK cells in blood and duration of circulation. Anti-tumor responses will be monitored by prostatic surface antigen (PSA) levels in the blood, circulating tumor DNA in the blood, and the number and size of metastatic lesions using piflufolastat F 18 and quantified by artificial intelligence.

“There are two key elements for successful immunotherapy. There must be immune cells in the tumor and the drug must convert those immune cells into cancer killing cells,” Mark Lowdell PhD, chief scientific officer,INmune Bio and inventor ofINKmune™, added.¹ “Prostate cancer has many resting NK cells, and we believe INKmune will convert those resting NK cells into memory-like NK cells that can attack the tumor.”

INmune received a favorable patentability opinion on INKmune, also known as INB16, from an examiner from the International Search Authority at the United States Patent & Trademark Office in October 2023.²

“Patents covering novel cell lines are somewhat rare in practice and form a very small number of total patents issued,” Joshua Schoonover, Esq, in-house General Counsel, INmune, said in a statement at that time.² “The company is exploring several potential commercial applications of the INB16 cell line, including uses in cancer research, as well as therapeutic uses, such as applications for treating various cancer indications, or for enhancing other NK cell products to gain advantages, such as improved avidity or memory-like functions.”

REFERENCES

1. INmune Bio announces first patient dosed in a phase 1/2 study of INKmune™ in patients with metastatic castration-resistant prostate cancer. News release. INmune Bio. January 2, 2024. https://www.globenewswire.com/news-release/2024/01/02/2802613/0/en/INmune-Bio-Announces-First-Patient-Dosed-in-a-Phase-1-2-Study-of-INKmune-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer.html
2. INmune Bio Inc. patent claims covering INB16 cell line and INKmune™ therapeutic composition given Favorable Patentability Opinion by International Search Authority. News release. Inmune Bio. October 31, 2023. https://www.inmunebio.com/news-2/2023/543-muneioncatentlaimsovering16ellineand20231031