8-K: INmune Bio Advances Cancer and Alzheimer's Programs with Positive Clinical Updates

INmune Bio announces the completion of the first cohort and initiation of the second cohort in its Phase 1/2 trial of INKmune for prostate cancer, and provides an update on two Alzheimer's patients receiving XPro under compassionate use for over three years.

Summary

• INmune Bio has completed the first cohort of its Phase 1/2 trial for INKmune, a natural killer cell therapy for metastatic castration-resistant prostate cancer (mCRPC), and has initiated the second cohort.
• The first cohort involved 9 administrations of INKmune with no significant adverse events, and over 20 infusions have been given safely across multiple trials without the need for conditioning therapy, pre-medication, or cytokine support.
• The Phase 1/2 trial, known as CaRe PC, will test up to three doses of INKmune in up to 30 patients with mCRPC, using a modified Bayesian design for dose escalation.
• The trial will assess safety, immunologic responses, and anti-tumor responses, including changes in tumor-killing memory-like NK cells, PSA levels, and metastatic lesions using AI analysis of PSMA imaging and ctDNA.
• The company has manufactured all planned doses of INKmune for the Phase 1 study and has qualified assays to Phase 2 standards, with plans for BLA-standard validation in 2025.
• Two patients from a 2021 Phase 1b Alzheimer's disease trial have continued to receive XPro for over three years under the Australian Special Access Scheme, with reports of stable cognitive function and no adverse reactions.
• These patients were originally part of a 3-month trial and a 12-month open label extension, and their primary care physicians have reported positive outcomes with continued XPro treatment.
• The company is on track with its Phase 2 clinical trial investigating XPro for Alzheimer's disease in patients with biomarkers of inflammation.

Sentiment

Score: 8

Explanation: The document presents positive updates on both the cancer and Alzheimer's programs, with no significant negative news. The safety data for INKmune and the long-term stability reported for XPro are encouraging.

Positives

• The INKmune therapy has demonstrated a strong safety profile in the mCRPC trial, with no significant adverse events reported in the first cohort.
• The ability to administer INKmune on an outpatient basis is appealing to both patients and clinical teams.
• The long-term use of XPro in two Alzheimer's patients has shown stable cognitive function, which is encouraging given the typical progression of the disease.
• The company has successfully manufactured all planned doses of INKmune for the Phase 1 study, ensuring sufficient supply for the trial.
• The company is progressing with its clinical trials and is on track with its Phase 2 trial for XPro in Alzheimer's disease.

Negatives

• The clinical trials are still in early stages, and there is no guarantee of specific outcomes or regulatory approvals.
• The company's ability to produce more drug for clinical trials and secure additional funding are potential risks.
• The long-term efficacy of INKmune and XPro is still under investigation.

Risks

• The company faces risks related to producing sufficient drug supply for clinical trials.
• There is a risk that the clinical trials may not achieve the desired outcomes.
• The company's ability to secure additional funding is crucial for continued operations and research.
• Regulatory approval for INKmune and XPro is not guaranteed.

Future Outlook

The company is focused on completing the Phase 1/2 trial for INKmune and the Phase 2 trial for XPro, with plans for BLA-standard validation of assays in 2025. The company will continue to monitor the long-term effects of XPro in Alzheimer's patients under compassionate use.

Management Comments

• Prof. Mark Lowdell, CSO of INmune Bio, stated that INKmune could be an optimal therapy for prostate cancer by transforming resting NK cells into cancer-killing cells.
• R.J. Tesi, M.D., CEO of INmune Bio, expressed delight that the long-term administration of XPro has been safe and well-tolerated, with patients maintaining stable cognitive functions for more than three years.

Industry Context

The announcements align with the growing interest in immunotherapies, particularly natural killer cell therapies, for cancer treatment and the ongoing search for effective treatments for Alzheimer's disease. The use of AI in analyzing imaging data is also a trend in clinical trials.

Comparison to Industry Standards

• The INKmune trial's use of a modified Bayesian design for dose escalation is a modern approach to clinical trial design, allowing for efficient dose finding.
• The reported safety profile of INKmune, with no need for conditioning therapy or pre-medication, is a positive differentiator compared to some other cell therapies.
• The long-term compassionate use of XPro in Alzheimer's patients, with reported stable cognitive function, is notable given the typical progression of the disease, and compares favorably to the results of some other Alzheimer's drug trials.
• The use of piflufolastat F 18 (Plarify) for PSMA imaging is a standard practice in prostate cancer trials, and the use of AI to quantify metastatic lesions is an innovative approach.

Stakeholder Impact

• Shareholders will likely view the positive clinical updates favorably.
• Patients with mCRPC may benefit from the development of INKmune therapy.
• Patients with Alzheimer's disease may benefit from the continued development of XPro.
• Employees of INmune Bio will be involved in the ongoing clinical trials and research.

Next Steps

• The company will continue the Phase 1/2 trial of INKmune in mCRPC, enrolling patients in the second cohort.
• The company will continue to monitor the two Alzheimer's patients receiving XPro under the Special Access Scheme.
• The company will proceed with the Phase 2 clinical trial investigating XPro for treatment of AD.
• The company will plan for BLA-standard validation of assays in 2025.

Key Dates

Keywords

INKmune, XPro, Prostate Cancer, Alzheimer's Disease, Natural Killer Cell Therapy, Clinical Trial, Immunotherapy, Metastatic Castration-Resistant Prostate Cancer, Compassionate Use, Phase 1/2 Trial