INmune Bio Inc. (NASDAQ: INMB) has announced the completion of enrollment in its Phase 2 Alzheimer’s Disease (AD) trial (AD02) and positive data from its Phase I/II trial of INKmune™ in metastatic Castration-Resistant Prostate Cancer (mCRPC). The company also reported its financial results for the third quarter of 2024.
Alzheimer's Disease Trial Update
The AD02 trial, a global, blinded, randomized Phase 2 study, focuses on patients with early AD and biomarkers indicative of elevated neuroinflammation. Enrollment concluded after determining sufficient patients were in screening to meet the target of 201 patients, with potential for modest over-enrollment. Interim analysis of blinded data revealed exceptional performance of the novel cognitive measure EMACC, showing a highly significant correlation (p<0.001) with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), an accepted endpoint for AD trials. The correlation between baseline EMACC and CDR-SB was confirmed by an independent review. EMACC also demonstrated high reliability, with a correlation of 0.93 between screening and the first study visit. Furthermore, EMACC effectively differentiated between patients with CDR global ratings of 0.5 (prodromal AD) and 1.0 (mild dementia), with a large effect size (Cohen’s d) of 0.87 (p<0.0001), highlighting its sensitivity and precision.
INKmune™ Platform Progress
INKmune™, in a Phase I/II trial (CaRe PC) for mCRPC, demonstrated excellent safety and increased NK-Cell activity in the first dosing cohort. Blinded analysis showed changes in NK cell phenotype and function, with 2 of 3 patients exhibiting increased circulating activated NK cells and all three showing sustained increased NK cell function for over 40 days post-infusion. One patient experienced a transient 21% decrease in PSA associated with increased NK cell activity. To date, 21 administrations of INKmune™ have been given on an outpatient basis with no significant adverse events, including cytokine release syndrome (CRS). The CaRe PC trial has dosed the first patient in the highest dose cohort and opened Phase II enrollment for the intermediate dose group. A new formulation of INKmune™ supports the highest trial dose with single bag administration, and bioreactor capacity has been expanded to prepare for scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA, including validation data supporting an alternative critical reagent to improve supply chain redundancy.
Soluble TNF as Therapeutic Target
A recent publication in Cell Reports highlighted soluble TNF as a critical cytokine checkpoint that converts microglia from reparative, remyelinating cells to damaging, demyelinating cells. The data suggest that blocking soluble TNF is a promising strategy for treating demyelinating diseases.
Financial Update
INmune Bio reported a net loss attributable to common stockholders of approximately $12.1 million for the quarter ended September 30, 2024, compared to $8.6 million for the same period in 2023. Research and development expenses totaled approximately $10.1 million, compared to $6.0 million in the prior year. As of September 30, 2024, the Company had cash and cash equivalents of approximately $33.6 million.
Upcoming Milestones
Top-line data from the Phase 2 Alzheimer’s trial is expected in the second quarter of 2025. A Phase II trial of XPro™ in patients with Treatment-Resistant Depression is expected to initiate in the second half of 2024. Enrollment in the Phase I portion of the INKmune™ mCRPC trial is expected to complete by year-end, with Phase II enrollment expected to complete in Q2 2025.
