Study progresses of NK cell therapy in mCRPC

Dosing and patient enrollment continue to progress in the phase 1/2 CaRe PC trial (NCT06056791), evaluating the natural killer (NK) cell targeted therapy INKmune in patients with metastatic castration-resistant prostate cancer (mCRPC), according to a news release from INmune Bio, the developer of the therapy.¹

INmune also announced that they have planned the process for FDA Biologic License Application standard validation in 2025.

According to the company, all patients have been successfully dosed in the first cohort of patients, and the Safety Review Committee (SRC) has granted approval for progression of the study to the second dose level (cohort 2). The first patient in the second cohort has been identified and will undergo screening in preparation for treatment.

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

INKmune is an NK cell-targeting therapy that is given as an outpatient therapy via intravenous infusion without the need for pre-medication or cytokine support.

INmune announced the launch of the CaRe PC trial in January 2024 with the dosing of the first patient.² To date, 9 doses of INKmune have been administered in the study, with no significant adverse events noted across any patients.

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 10⁸ INKmune), medium (3 x 10⁸ INKmune), or high (5 x 10⁸ INKmune), with each dose level including up to 10 patients.

Those enrolled in the study will be followed for 6 months after treatment to assess their immunologic and anti-cancer responses to therapy. 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 circulation. The investigators will measure anti-tumor responses by monitoring the level of prostatic specific antigen in the blood, using artificial intelligence to quantify the number and size of metastatic lesions on PSMA imaging with piflufolastat F 18 (Pylarify), and by measuring circulating tumor DNA in the blood.

The primary goals of the study are to assess the safety of INKmune in patients with mCRPC and to determine 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.³ 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.

INmune also announced that they have planned the process for FDA Biologic License Application standard validation in 2025.

References

1. 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. News release. April 29, 2024. Accessed April 30, 2024. https://www.globenewswire.com/news-release/2024/04/29/2871192/0/en/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-Prostat.html

2. 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-/

3. 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