INB-03
- Generic Name
- INB-03
INmune Bio Partners with CGT Catapult to Scale CORDStrom Manufacturing for Rare Skin Disease Treatment
• INmune Bio has partnered with Cell and Gene Therapy Catapult to establish commercial-scale manufacturing for CORDStrom, a promising therapy for recessive dystrophic epidermolysis bullosa that showed positive results in Phase 2 trials.
• The collaboration leverages CGT Catapult's Stevenage Manufacturing Innovation Centre to scale production for approximately 4,000 children with intermediate to severe RDEB across the US, UK, and EU.
• Following CORDStrom, INmune Bio plans to transition production of INKmune, its NK-priming cell medicine currently in Phase 2 trials for metastatic castration-resistant prostate cancer.
INmune Bio Reveals Promising Demographics in MINDFuL Phase II Alzheimer's Trial
• INmune Bio presented baseline demographics from its MINDFuL Phase II trial showing 208 patients with early Alzheimer's disease and confirmed biomarkers of inflammation, with 69.2% being APOE ε4 carriers.
• The trial is evaluating XPro™, a dominant-negative TNF inhibitor administered weekly at 1.0 mg/kg, with cognitive function measured by the Early and Mild Alzheimer's Cognitive Composite (EMACC) as the primary endpoint.
• Patient characteristics closely resemble those in successful Phase III Alzheimer's trials, with 44% diagnosed with MCI and 56% with mild AD, suggesting strong translational potential when topline results are released in June 2025.
INmune Bio Advances to Phase II Trial of INKmune™ Therapy for Metastatic Prostate Cancer
• INmune Bio's Natural Killer cell therapy INKmune™ demonstrates strong safety profile in Phase I trial for metastatic castration-resistant prostate cancer, enabling progression to Phase II high-dose cohort.
• The therapy can be administered in an outpatient setting and has shown promising immunologic effects even in the low-dose cohort, with NK cells persisting for over 100 days in patients.
• Scientific Review Committee unanimously approves opening of all Phase II cohorts for enrollment, with data presentation scheduled at the upcoming Innate Killer Summit in March.
INKmune Trial for Metastatic Prostate Cancer Expands to VA Medical Center
• 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).
Insmed's Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025
• The FDA has accepted Insmed's New Drug Application for brensocatib in bronchiectasis, granting Priority Review with a PDUFA target action date of August 12, 2025.
• Insmed anticipates launching brensocatib in the U.S. in the third quarter of 2025, pending FDA approval, with regulatory submissions planned for the EU, UK, and Japan in 2025.
• ARIKAYCE global revenue grew 19% in 2024, and Insmed projects 2025 revenues between $405 million and $425 million, representing double-digit growth.
• A Phase 3 study of TPIP in pulmonary hypertension associated with interstitial lung disease is planned for the second half of 2025.
INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial Targeting Neuroinflammation
• INmune Bio has finalized enrollment of 208 patients in its Phase 2 AD02 trial for early Alzheimer's disease, focusing on individuals with biomarkers indicating neuroinflammation.
• The AD02 trial is a global, blinded, randomized study evaluating XPro™ in patients with early Alzheimer's, with 56% categorized as mild AD and 44% as MCI.
• XPro™ targets glial cells to reduce neuroinflammation, aiming to decrease neurodegeneration and improve synaptic function, with topline cognitive results expected in Q2 2025.
• The primary endpoint of the AD02 trial is the change from baseline in cognitive function after 24 weeks, measured by EMACC and CDR-SB.
INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial Targeting Neuroinflammation
• 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 Completes Enrollment in Phase 2 Alzheimer's Trial Targeting Neuroinflammation
• INmune Bio has finalized enrollment of 208 patients in its Phase 2 AD02 trial for early Alzheimer's disease, exceeding the initial target.
• The AD02 trial is a global, blinded, randomized study focusing on patients with biomarkers indicating elevated neuroinflammation.
• XPro™, the drug being tested, aims to reduce neurodegeneration and improve synaptic function by targeting glial cells that drive neuroinflammation.
• Top-line cognitive results from the AD02 trial are expected to be released in the second quarter of 2025, marking a key milestone.
INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial and Reports Positive NK-Cell Data in Prostate Cancer Study
• INmune Bio completed enrollment for its Phase 2 Alzheimer’s Disease trial (AD02) focused on early AD patients with elevated neuroinflammation biomarkers.
• Interim analysis of the AD02 trial's blinded data showed a highly significant correlation (p<0.001) between EMACC cognitive measure and CDR-SB, a standard endpoint for AD trials.
• INKmune™ demonstrated excellent safety and increased NK-Cell activity in the first dosing cohort of a Phase I/II trial for metastatic Castration-Resistant Prostate Cancer (mCRPC).
• A new INKmune™ formulation supports the highest trial dose with single bag administration and expansion of bioreactor capacity for scalable manufacturing.
INmune Bio to Highlight EMACC Cognitive Test in Alzheimer's Trials
• INmune Bio will host a webinar on November 7, 2024, to discuss the Early and Mild Alzheimer’s Cognitive Composite (EMACC) as a tool for measuring cognitive change in early Alzheimer’s trials.
• The webinar will feature experts discussing EMACC's advantages in assessing cognitive changes and the regulatory landscape for Alzheimer’s drug development.
• Data on EMACC's sensitivity and performance from a Phase II Alzheimer’s trial will be presented at the Clinical Trial in Alzheimer’s Disease (CTAD) conference.
• INmune Bio is currently conducting a Phase II trial using XPro™ with EMACC and CDR-SB as primary endpoints to measure cognitive function changes.
INmune Bio's XPro™ Promotes Remyelination in Animal Models, Showing Promise for Alzheimer's Treatment
• 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.
INmune Bio Completes Enrollment for Phase 2 Trial of XPro™ in Early Alzheimer's Disease
• INmune Bio has concluded patient enrollment for its Phase 2 AD02 trial, targeting early Alzheimer's Disease (AD) patients with elevated neuroinflammation biomarkers.
• The AD02 trial is a global, blinded, randomized study evaluating XPro™ (pegipanermin) in patients with mild cognitive impairment and mild AD.
• The trial aims to enroll over 201 patients, with those currently in screening still eligible, potentially leading to a modest over-enrollment to enhance trial power.
• XPro™, a selective inhibitor of soluble TNF, is being investigated for its potential to reduce neuroinflammation and improve cognitive function in AD patients.
INmune Bio's AD02 Phase 2 Trial Shows EMACC Correlation with CDR-SB in Alzheimer's
• INmune Bio's AD02 Phase 2 trial data shows a highly significant correlation (p<0.001) between EMACC and CDR-SB, a key endpoint in Alzheimer's trials.
• The EMACC measure demonstrated high reliability with a correlation of 0.93 between screening and the first study visit, indicating consistent performance.
• EMACC effectively differentiated between prodromal AD and mild dementia, with a Cohen’s d effect size of 0.87 (p<.0001), highlighting its precision.
• The trial design, utilizing EMACC as the primary endpoint, is believed to de-risk the clinical program, with topline data expected six months after enrollment completion.
INmune Bio Announces $12 Million Offering to Advance Clinical Programs
• INmune Bio is offering 2,341,260 shares of common stock along with warrants to raise approximately $12 million for clinical trials and corporate purposes.
• The offering includes warrants exercisable beginning March 16, 2025, at $6.40 per share, expiring on March 16, 2030, subject to certain acceleration conditions.
• Net proceeds will fund the Phase 2 Alzheimer's disease trial of XPro, initiate a Phase 2 trial for treatment-resistant depression, and continue INKmune programs.
• Insider participation includes officers, directors, and employees purchasing approximately $800,000 of shares and warrants under similar terms.
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