INmune Bio | MedPath

INmune Bio Plans FDA Submission for CORDStrom in Rare Skin Disease RDEB

3 months ago

• INmune Bio announces plans to submit Biologics License Application (BLA) to FDA for CORDStrom following successful Type C meeting. • The company will pursue marketing authorization in both US and European markets based on positive MissionEB clinical trial results in pediatric RDEB patients. • Double-blind, randomized, placebo-controlled MissionEB study demonstrates favorable benefit-risk profile for CORDStrom as a disease-modifying therapy.

INKmune Trial for Metastatic Prostate Cancer Expands to VA Medical Center

4 months ago

• INmune Bio's CaRe PC trial, evaluating INKmune in metastatic castration-resistant prostate cancer (mCRPC), has expanded to the West Los Angeles VA Medical Center. • The first patient at the VA Medical Center has been dosed with the 'medium' dose of INKmune, marking the official expansion of the trial to veterans with mCRPC. • The Phase 1/2 trial assesses the safety and anti-tumor activity of INKmune across three dose levels, with a six-month follow-up to measure immune and anti-cancer responses. • Initial Phase 1 data showed changes in NK cell phenotype and function in all patients, with one patient experiencing a transient decrease in prostate-specific antigen (PSA).

INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial Targeting Neuroinflammation

6 months ago

• INmune Bio has finalized patient randomization for its Phase 2 trial (AD02) in early Alzheimer's disease, enrolling a total of 208 patients. • The trial focuses on individuals with elevated neuroinflammation biomarkers, with 56% having mild Alzheimer's and 44% with mild cognitive impairment. • XPro™, which targets glial cells to reduce neuroinflammation and enhance brain function, is being assessed, with cognitive results expected in Q2 2025. • The primary endpoint of the trial is measuring cognitive function changes after 24 weeks using the EMACC and CDR-SB metrics.

INmune Bio's XPro Shows Promise in Alzheimer's, Faces Financial Hurdles

7 months ago

• INmune Bio is advancing clinical trials for Alzheimer's disease (AD) and metastatic castrate-resistant prostate cancer (mCRPC), with promising early data for XPro in AD. • The company's lead drug XPro significantly decreased biomarkers of neurodegeneration and improved synaptic function in a Phase I trial for Alzheimer's disease. • INmune Bio anticipates high operating expenses and relies on additional funding, facing potential liquidity issues that raise concerns about its long-term viability. • A Phase II trial for treatment-resistant depression (TRD) with XPro is planned, supported by a $2.9 million grant from the National Institute of Mental Health (NIMH).

INmune Bio's XPro™ Promotes Remyelination in Animal Models, Showing Promise for Alzheimer's Treatment

7 months ago

• INmune Bio's XPro™ demonstrated the ability to promote remyelination in animal models of demyelinating diseases, according to a publication in *Cell Reports*. • The study showed XPro1595 converts microglia from damaging to reparative cells by blocking soluble TNF, a key mechanism in neurodegenerative diseases. • These findings have implications for treating various CNS diseases, including Alzheimer's Disease, where myelin loss compromises neuron function. • INmune Bio anticipates reporting top-line cognitive results from its Phase II trial in early Alzheimer's patients in the first half of 2025.