Drugs / INKmune
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05933070 | Jun 2020 → Mar 2024 | acute myeloid leukemia, myelodysplastic syndrome with excess blasts | Inmune Bio, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT06056791 | Nov 2023 → Sep 2025 | castration-resistant prostate carcinoma | Inmune Bio, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-08-04 | Inmune Bio, Inc. | Results INmune Bio’s CaRe PC Trial of INKmune™ in Metastatic Castration-Resistant Prostate Cancer Meets Endpoints and Is Closed to Enrollment inmunebio.com ↗
INKmune™ was well tolerated at all three dose levels in the trial, demonstrating an excellent safety profile, the primary endpoint of CaRe PC. |
| 2025-02-12 | Inmune Bio, Inc. | Regulatory INmune Bio Opens Phase II in High Dose Cohort of INKmune™ Trial in Prostate Cancer inmunebio.com ↗
The SRC unanimously voted to open all Phase II cohorts of the CaRePC trial to enrollment. |
| 2024-09-26 | Inmune Bio, Inc. | Results INKmune™ Demonstrates Excellent Safety and Increased NK-Cell Activity in First Dosing Cohort inmunebio.com ↗
The Company is pleased to announce initial results from the first patient cohort in the trial. |
| 2024-07-23 | Inmune Bio, Inc. | Results INmune Bio Inc. Publishes Novel Biology on Natural Killer Cancer Immunotherapy INKmune™ in the Journal for ImmunoTherapy of Cancer inmunebio.com ↗
The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune TM priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. |
| 2024-04-29 | Inmune Bio, Inc. | Results 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 inmunebio.com ↗
So far, there have been 9 administrations of INKmune in the mCRPC study given as an out-patient with no significant adverse events. |
| 2023-05-08 | Inmune Bio, Inc. | Regulatory INmune Bio, Inc. Announces FDA Clearance of IND Application for INKmune™, a Natural Killer Therapy, for a Phase I/II Trial in Metastatic Castration-Resistant Prostate Cancer inmunebio.com ↗ |
| 2023-04-03 | Inmune Bio, Inc. | Regulatory INmune Bio, Inc. Announces Submission of Investigational New Drug (IND) Application for INKmune™ to the U.S. Food and Drug Administration for Treatment of Metastatic Castration-Resistant Prostate Cancer inmunebio.com ↗ |
| 2022-12-08 | Inmune Bio, Inc. | Results INmune Bio, Inc. Data at ASH Highlight Innovative Natural Killer Cell Therapeutic Platform Showing 100+ Day Persistence of Cancer Killing Memory Like NK Cells in Patients with AML/MDS Following Treatment with INKmune™ inmunebio.com ↗
“The treatment of these patients with advanced hematologic malignancies has produced proof-of-concept data for INKmune while expanding insight into the role of NK cells in controlling cancer,” said Dr. Mark Lowdell, CSO of INmune Bio. |
| 2022-10-19 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines for INKmune inmunebio.com ↗ |
| 2022-04-04 | Inmune Bio, Inc. | Results INmune Bio, Inc. Highlights INKmune™ Data Featured in NK Cells in Solid Tumors Workshop at Innate Killer Summit inmunebio.com ↗
Dr. Lowdell observed that INKmune™, unlike IL15 and other NK-activating cytokines, simultaneously upregulates all mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell. |
| 2021-12-01 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Two Presentations at the 2021 British Society of Immunology Congress and Provides 119-day data on First patient in MDS trial. inmunebio.com ↗
At 119 days post first treatment, 60% of the patient’s NK cells showed the activated, tumor killing phenotype compared to fewer than 15% before INKmune therapy. |
| 2021-11-03 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Third Quarter 2021 Results and Provides Business Update inmunebio.com ↗
In the first patient treated in our Phase I study of INKmune™ in high-risk myelodysplastic syndrome, INKmune™ was found to safely produce cancer killing memory-like NK cells while increasing proliferation and persistence of those NK cells. |
| 2021-08-25 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Biomarker Data Demonstrating that the First Patient Treated with its NK Cell Priming “Pseudokine”, INKmune™, Successfully Produced Memory-Like NK Cells inmunebio.com ↗ |
| 2021-03-22 | Inmune Bio, Inc. | Results INmune Bio, Inc. Announces Professor Mark Lowdell, PhD, CSO to Deliver Presentations at Two Upcoming Medical Meetings inmunebio.com ↗
Use of two of the latest state-of-the-art cell:cell analysis technologies has demonstrated that INKmune™ increases NK cell killing of tumor cells by strengthening the binding of the NK to the tumor cell; the avidity . |
| 2020-06-11 | Inmune Bio, Inc. | Regulatory INmune Bio, Inc. Receives Regulatory Approval from UK MHRA to Initiate Phase I Trial of INKmune in Patients with High-risk MDS inmunebio.com ↗ |
| 2019-06-27 | Inmune Bio, Inc. | Results INmune Bio Announces Publication of Data on INKmune Primed NK cells in Peer-Reviewed Journal PLOS ONE inmunebio.com ↗
The paper identifies a unique signaling “fingerprint” expressed by NK cells after binding to CTV-1 tumor cells, which is the parent clone of INmune Bio’s own INB16 cells. |
| 2018-12-19 | Inmune Bio, Inc. | Regulatory INmune Bio Granted Phase I Clinical Trial Authorization of Lead Product INKmune™ in Refractory and Recurrent Ovarian Cancer Patients inmunebio.com ↗
INmune Bio Inc. , an immunotherapy company developing treatments to reprogram the innate immune system to fight disease, announced today that it has been granted Clinical Trial Authorization (CTA) by the United Kingdom (UK) regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA), for a Phase I clinical trial of its lead therapeutic candidate INKmune™. |
All press releases naming this drug 23 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | INKmune | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05933070 ↗ |
| Action | Activate | “using in vivo priming and activation of natural killer (NK) cells” NCT05933070 ↗ |
| Modality | Cell therapy | “INKmune is a suspension of INB16 cells which have been rendered replication incompetent.” NCT05933070 ↗ |
| Route | Intravenous | “administered by a slow intravenous injection” NCT05933070 ↗ |