INKmune (primed NK cell therapy) / INmune Bio - LARVOL DELTA

INmune Bio Inc. Announces First Quarter 2025 Results and Provides Business Update (GlobeNewswire) - "Upcoming Events and Milestones:...Complete enrollment in the Phase II portion of INKmune in metastatic castration-resistant prostate cancer trial before year end. We expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available."

Enrollment status • P2 data • Castration-Resistant Prostate Cancer

INmune Bio Inc. Announces Year End 2024 Results and Provides a Business Update (GlobeNewswire) - "Upcoming Events and Milestones: Top line cognitive results and secondary endpoints from the AD02 trial in Alzheimer’s Disease will be available in June 2025....Data from the ongoing INKmune trial in mCRPC will be released as they become available. The next data set should be released in Q2 or Q3, 2025. A Phase II trial of XPro in patients with Treatment-Resistant Depression will begin enrollment soon once the NIH releases funds for the trial."

Enrollment status • P1/2 data • P2 data • Alzheimer's Disease • Castration-Resistant Prostate Cancer • Depression

INmune Bio Opens Phase II in High Dose Cohort of INKmune Trial in Prostate Cancer (GlobeNewswire) - "INmune Bio Inc...continues to advance its Natural Killer (NK) cell therapy, INKmune, in a Phase I/II trial (the 'CaRe PC' trial) for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort. The Scientific Review Committee (SRC) charter is to review the safety data from the patients treated in the Phase I portion of the trial as required by the FDA. Yesterday, the SRC held the third meeting evaluating the safety in INKmune therapy in men with mCRPC. The SRC unanimously voted to open all Phase II cohorts of the CaRePC trial to enrollment....Data to be presented at the 10th Annual Innate Killer Summit, March 3-5."

P1/2 data • Trial status • Metastatic Castration-Resistant Prostate Cancer

INmune Bio Inc. Expands INKmune Trial in Prostate Cancer to Veterans (GlobeNewswire) - "INmune Bio, Inc...has an ongoing Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the participation of a patient at the West Los Angeles VA Medical Center in the trial. The participant received the investigational intervention, as an out-patient per the protocol, under the care of Matthew Rettig, MD., Chief, Hematology-Oncology, VA Greater Los Angeles Healthcare System, Professor of Medicine and Urology, Medical Director Prostate Cancer Program, David Geffen School of Medicine and the Jonsson Comprehensive Cancer Center at the UCLA....The Veteran received the 'medium' dose of INKmune initiating the Phase II portion of the trial."

Trial status • Castration-Resistant Prostate Cancer • Prostate Cancer

INmune Bio Inc. Announces Third Quarter 2024 Results and Provides Business Update (GlobeNewswire) - "Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial by year-end. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available."

Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

INKmune Demonstrates Excellent Safety and Increased NK-Cell Activity in First Dosing Cohort (GlobeNewswire) - P1/2 | N=30 | CaRe (NCT06056791) | Sponsor: Inmune Bio, Inc. | "Blinded analysis of the monitoring blood samples from the first three patients showed changes in the phenotype and function of the patient’s NK cells. Although this is the lowest dose cohort, 2 of 3 patients showed an increase in circulating activated NK cells and all three showed increased NK cell function sustained for more than 40 days after the final INKmune infusion. One patient showed a transient 21% decrease in PSA associated with the increase in NK cell activity and function."

P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer

INmune Bio Inc. Announces Second Quarter 2024 Results and Provides Business Update (GlobeNewswire) - "Upcoming Events and Milestones: Expect to complete enrollment in the Phase I portion of INKmune in metastatic castration-resistant prostate cancer trial in Q4 2024. The Phase II portion is expected to complete enrollment in Q2, 2025, however we expect to provide periodic updates on the immunologic and therapeutic response to INKmune as data becomes available."

Enrollment status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer

INmune Bio Inc. Publishes Novel Biology on Natural Killer Cancer Immunotherapy INKmune in the Journal for ImmunoTherapy of Cancer (GlobeNewswire) - "The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers further supporting INKmune’s in vivo treatment methodology....INmune Bio is currently conducting a trial of INKmune in the treatment of metastatic castration-resistant prostate cancer. Preliminary results from that trial are expected later this year."

P1/2 data • Preclinical • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology

Proteomic and phenotypic characteristics of memory-like natural killer cells for cancer immunotherapy. (PubMed, J Immunother Cancer) - "NK cell "memory" is a physiological state associated with resistance to MHC-mediated inhibition, increased metabolic function, mitochondrial fitness and avidity to NK-resistant target cells."

Journal • Acute Myelogenous Leukemia • Cognitive Disorders • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • B3GAT1 • CD69 • ICAM1 • IL12A • IL2RA

INmune Bio Inc. Announces First Quarter 2024 Results and Provides Business Update (GlobeNewswire) - "The first cohort in the Phase I/II open label trial of INKmune in metastatic castration-resistant prostate cancer (mCRPC) successfully completed the first dosing. Following review by the Safety Review Committee (SRC), approval was granted to proceed with the second dose level (cohort 2) and two patients have been enrolled. The first patient of the middle dose cohort is expected to be treated this month....Upcoming Events and Milestones:...Expect to complete enrollment in the Phase I portion of the mCRPC trial by end of Q3 2024. The Phase II portion is expected to complete enrollment in Q2, 2025."

Trial status • Metastatic Castration-Resistant Prostate Cancer

LAUREL: A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Inmune Bio, Inc. | Trial completion date: Jan 2025 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2024 ➔ Mar 2024; Slow/low Enrollment

Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

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 (GlobeNewswire) - "INmune Bio, Inc...continues to advance its Natural Killer (NK) cell therapy, INKmune, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the successful completion of the first cohort in the trial. Following review by the Safety Review Committee (SRC), approval has been granted to proceed with the second dose level (cohort 2). The first patient of the second cohort has been identified and will undergo screening to prepare for treatment."

Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

INmune Bio Inc. Announces $9.7 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules (GlobeNewswire) - "INmune Bio, Inc...today announced today that it has entered into definitive agreements for the sale and purchase of 986,000 shares of its common stock and warrants to purchase up to an aggregate of 986,000 shares of its common stock at an offering price of $9.84 per share of common stock and accompanying warrant. The warrants include an acceleration clause upon positive top-line data in the Company’s Phase 2 Alzheimer’s Disease program...The warrants terminate on the earlier of (1) the two (2) year anniversary of the initial exercise date of the warrant or (2) thirty (30) trading days following the reporting of positive top-line data (EMACC) in the Phase 2 Alzheimer's program of XPro1595...The net proceeds is expected to fund the Company through the readout of the ongoing Phase 2 trial (AD02) in patients with Early Alzheimer’s Disease (AD) using XPro and through the metastatic castration-resistant prostate cancer (mCRPC) Phase 1 trial using the INKmune technology."

Financing • Alzheimer's Disease • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

INmune Bio Inc. Announces Year End 2023 Results and Provides a Q4 Business Update (INmune Bio Press Release) - "INmune Bio Inc....announces its financial results for the year ended December 31, 2023 and provides a business update...INKmune Platform: The first patient was enrolled in the Phase I/II open label trial of INKmune in metastatic castration-resistant prostate cancer (mCRPC) in the final week of 2023. Enrollment of 3 patients in cohort 1 is complete and cohort 2 will open for enrolment after review of the first cohort by the Data Safety Monitoring Committee in mid-April. Phase I patient enrollment at all three dose levels is expected to be completed by September. and then roll directly into the phase 2 program....The third patient for the INKmune AML program in UK and EU has been enrolled and subsequent to their completion of follow-up, the company will wind down the AML program to focus resources on the prostate-cancer program and other solid tumors."

DSMB • Enrollment status • Acute Myelogenous Leukemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of INKmune in Patients With mCRPC (CaRe Prostate) (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Inmune Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune in Patients with Metastatic Castration-Resistant Prostate Cancer (GlobeNewswire) - "INmune Bio, Inc...dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023....CaRe PC is an open label Phase I/II trial that will test up to three doses of INKmune™ in men with mCRPC."

Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

INmune Bio Inc. Announces Third Quarter 2023 Results and Provides Business Update (Yahoo Finance) - "On track to have FDA lift clinical hold on the use of XPRO to treat patients with CNS disease in the US by end-of-year 2023. Top-line results for the Phase II XPro™ trial for treatment of patients with early Alzheimer’s disease with biomarkers of neuroinflammation are expected end-of-year 2024. Initiate a Phase II trial of XPro™ in patients with Treatment-Resistant Depression upon resolution of the ongoing FDA manufacturing review. Webinar on using XPro™ to promote remyelination in neurodegenerative disease. Additional open-label Phase I trial data of INKmune™ in high-risk MDS/AML in 2023. Initiation of open-label Phase I/II trial in prostate cancer in Q4 2023 with patient data expected during 2024."

FDA event • New P1/2 trial • New P2 trial • P1 data • P2 data • Acute Myelogenous Leukemia • Alzheimer's Disease • CNS Disorders • Depression • Genito-urinary Cancer • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Prostate Cancer • Solid Tumor

Study of INKmune in Patients With mCRPC (CaRe Prostate) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Inmune Bio, Inc.

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LAUREL: A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Inmune Bio, Inc.

New P1 trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

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 (GlobeNewswire) - "INmune Bio, Inc...announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for INKmune™, a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC)....The trial is expected to enroll the first of 30 patients in the second half of 2023. It will be opened at 4 more clinical study sites, with a goal to determine short and long-term safety of INKmune™, demonstrate the ability of INKmune™ to control prostate cancer tumor burden, and identify a dose of INKmune™ to be used in a future blinded randomized pivotal trial....The Company will host a Webinar...on Friday, 12 May at 11 AM EDT on to discuss why INKmune™ is well suited for the treatment of men with mCRPC and provide details of the clinical trial design."

Clinical protocol • IND • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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 (GlobeNewswire) - "INmune Bio...announced that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of INKmune™ to treat metastatic castration-resistant prostate cancer (mCRPC)....The trial is expected to take place in four or more medical centers in the U.S and will enroll approximately 30 patients in a flexible Bayesian design....The goal of the trial is to define the safety of INKmune and demonstrate the ability of INKmune-primed NK cells to attack prostate cancer."

IND • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

INmune Bio, Inc. Announces 2022 Results and Provides Business Update (GlobeNewswire) - "Upcoming Events and Milestones: (i) Additional open-label Phase 1 trial data of INKmune™ in high-risk MDS/AML in 2023; (ii) Initiation of a Phase I/II program in a prostate cancer upon the acceptance of the IND by the FDA."

IND • New P1/2 trial • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

In Vivo Generation of Memory-like NK Cells for the Treatment of AML and Myelodysplastic Syndrome; Early Clinical Applications of INKmuneTM (ASH 2022) - "INKmune priming increased NK glycolysis and oxidative phosphorylation whilst enhancing mitochondrial respiratory capacity and maintaining glycolytic reserve...The TIML-NK have a distinct phenotypic, proteomic and metabolomic signature which mirrors the activity in vitro and in vivo. This is the first time memory-like NK cells have been generated in vivo without the need for cytokine induction or support and our findings inform the development of more optimal NK cell-based immunotherapeutic strategies for cancer."

Preclinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • CCL3 • CD69 • CSF3 • IL6 • TNFA

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 (GlobeNewswire) - "The poster presents findings from patients who have received INKmune therapy for treatment of their AML/MDS and provides additional information on the biologic changes that occur in the patients’ NK cells after treatment with INKmune. Highlights include: Demonstrable and sustained NK activation in 3 of the 4 patients. Patient 4 had a high level of disease with low numbers of NK cells of which more than half her NK cells were immature; Persistent tumor killing memory-like NK cells in the patient with MDS for more than 100 days; NK activation temporally associated with significant changes in systemic levels of key cytokines including Macrophage Inflammatory Proteins (MIP1-a and MIP1-b)."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines for INKmune (GlobeNewswire) - "INmune Bio, Inc....announces positive solid tumor data in multiple cancer lines resistant to NK killing that can be overcome with administration of INKmune....The Company’s pre-clinical data show that INKmune primes NK cells from patients and from healthy donors to lyse NK-resistant ovarian (CaOva), prostate (CaPros), renal (RCC) and nasopharyngeal (NPC) cancer cells. When compared to rNK cells, which are normal NK cells from healthy donors or patients before treatment with INKmune, the INKmune primed NK cells demonstrated enhanced ability to kill these resistant tumor cell lines....The Company identified more than1,500 proteins that are upregulated in NK cells following INKmune priming and subsequent analysis compared them to NK cells primed with a cytokine cocktail of IL-12, IL-15 and IL-18....The company presented the data at the Innate Killer Summit Europe on October 19th."

Preclinical • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor