INmune Bio Advances to Phase II Trial of INKmune™ Therapy for Metastatic Prostate Cancer
Key Insights
INmune Bio's Natural Killer cell therapy INKmune™ demonstrates strong safety profile in Phase I trial for metastatic castration-resistant prostate cancer (search), 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.
INmune Bio Inc. (NASDAQ: INMB) has reached a significant milestone in advancing its innovative Natural Killer (NK) cell therapy, INKmune™, for treating metastatic castration-resistant prostate cancer (search) (mCRPC (search)). The clinical-stage immunology company has successfully completed the third and highest dose cohort of Phase I testing, paving the way for expansion into Phase II trials.
Safety Profile and Trial Progress
The Scientific Review Committee (SRC) conducted its third safety evaluation of INKmune™ therapy in mCRPC (search) patients, resulting in a unanimous decision to proceed with all Phase II cohorts of the CaRePC (search) trial. This development follows a comprehensive review of safety data as mandated by the FDA.
"INKmune™ can be given to men with mCRPC (search) in an out-patient setting and so far has an exemplary safety profile," stated RJ Tesi, MD, CEO of INmune. "Data from the low dose cohort has shown immunologic effects of INKmune™ therapy. The higher dose cohorts will help us understand the therapeutic benefits of INKmune™ therapy in treating men with mCRPC."
Innovative Treatment Mechanism
INKmune™ represents a breakthrough in NK cell therapy, utilizing a pharmaceutical-grade, replication-incompetent human tumor cell line that transforms patients' resting NK cells into tumor-killing memory-like NK cells (mlNK cells). The therapy has demonstrated remarkable persistence, with primed NK cells remaining active for more than 100 days in patients.
Trial Design and Patient Experience
The CaRePC (search) trial employs a Bayesian design with three ascending dose cohorts. Following successful medical review of the initial three patients in each cohort, the trial includes a six-patient Phase II extension at the two higher dose levels. Notable advantages of INKmune™ therapy include:
- No requirement for pre-medication or conditioning
- Simple intravenous infusion delivery
- Outpatient administration
- No additional cytokine therapy needed
Upcoming Data Presentation
Mark Lowdell, CSO of INMB and INKmune™'s inventor, will present the trial data at the 10th Annual Innate Killer Summit in San Diego on March 4th. The presentation will focus on INKmune™'s application in treating mCRPC (search) patients within the CaRePC (search) trial.
Broader Applications
While currently focused on mCRPC (search), INKmune™'s tumor-agnostic approach suggests potential applications across multiple cancer types, including leukemia, lymphoma, myeloma, and various solid tumors. The therapy's ability to function in hypoxic tumor microenvironments, coupled with its practical administration benefits, positions it as a promising advancement in cancer immunotherapy.