Trial launches of immunotherapy in mCRPC

The first patient has been dosed in the phase 1/2 CaRe PC trial (NCT06056791), evaluating the biologic therapy INKmune in patients with metastatic castration-resistant prostate cancer (mCRPC), announced INmune Bio, the developer of the therapy, in a news release.¹

"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," says Matthew B. Rettig, MD.

According to the company, INKmune is a natural killer (NK) cell-targeting therapy that is given as an outpatient therapy via intravenous infusion without the need for pre-medication or cytokine support.

“Results of immunotherapy trials for mCRPC have been disappointing. 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,” said Matthew B. Rettig, MD, in the news release.¹ Rettig is a professor of medicine and urology and the medical director of the prostate cancer program at the David Geffen School of Medicine at the University of California, Los Angeles and member of the Jonsson Comprehensive Cancer Center.

Overall, the open-label CaRe PC trial plans to enroll up to 30 adult patients with mCRPC. Patients may receive up to 3 doses of INKmune (given on days 1, 8, and 15) at a dose level of either low (1 x 10^8 INKmune), medium (3 x 10^8 INKmune), or high (5 x 10^8 INKmune), with each dose level including up to 10 patients.

Those included in the study will be followed for 6 months after treatment to assess their immunologic and anti-cancer responses to treatment. Immune responses will be measured by the number of tumor killing memory-like NK cells in the patient’s blood and how long those specialized NK cells remain in the circulation. The investigators will measure anti-tumor responses by monitoring the level of prostatic surface antigen in the blood, using AI to quantify the number and size of metastatic lesions on imaging with piflufolastat F 18, and by measuring circulating tumor DNA in the blood.

Mark Lowdell PhD, CSO of INmune Bio and inventor of INKmune, said in the news release, “There are 2 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. 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.”¹

The primary end points of the study include safety and the determination of a recommended dose level. Following the phase 1 dose escalation portion of the trial, the phase 2 portion will be initiated with 12 patients, who will be enrolled in up to 2 candidate optimal dose levels for final dose determination.² According to INmune, the dose level determined to be the best following both phases of the study will be used in a blinded, randomized registration trial of the therapy.

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 Inc. January 2, 2024. Accessed January 3, 2024. https://www.biospace.com/article/releases/inmune-bio-announces-first-patient-dosed-in-a-phase-1-2-study-of-inkmune-in-patients-with-metastatic-castration-resistant-prostate-cancer-/

2. Study of INKmune in patients with mCRPC (CaRe Prostate) (CaRe). ClinicalTrials.gov. Last updated September 29, 2023. Accessed January 3, 2024. https://clinicaltrials.gov/study/NCT06056791