Full Press Release Details
Bio Opens Phase II in High Dose Cohort of INKmune Trial in Prostate Cancer
BOCA RATON, Fla, Feb. 12, 2025 (GLOBE NEWSWIRE)
-- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to
advance its Natural Killer (NK) cell therapy, INKmune , in a Phase I/II trial (the "CaRe PC" trial) for men with metastatic
castration-resistant prostate cancer (mCRPC). The Company is pleased to announce completion of the third and highest dose cohort of the
Phase I portion of the trial allowing opening of the Phase II high dose cohort.
The Scientific Review Committee (SRC) charter
is to review the safety data from the patients treated in the Phase I portion of the trial as required by the FDA. Yesterday, the SRC
held the third meeting evaluating the safety in INKmune therapy in men with mCRPC. The SRC unanimously voted to open all Phase
II cohorts of the CaRePC trial to enrollment.
"INKmune can be given to men with
mCRPC in an out-patient setting and so far has an exemplary safety profile," said 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."
Mark Lowdell, CSO of INMB and inventor of INKmune ,
has been invited to speak at the 10th Annual Innate Killer Summit in San Diego on March 4th on
the use of INKmune to treat men with mCRPC in the CaRe PC trial. The trial has a Bayesian design with three ascending dose cohorts.
Now that the initial three patients in each cohort have passed medical review, there is a six patient Phase II extension at the two higher
dose levels. Patient recruitment continues to meet expectations.
INKmune is a pharmaceutical-grade, replication-incompetent
human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient's
resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune treatment converts the patient's own NK cells
into mlNK cells. In patients, INKmune primed tumor killing NK cells have persisted for more than 100 days. These cells function
in the hypoxic TME because due to up-regulated nutrient receptors and mitochondrial survival proteins.
INKmune is a patient friendly drug treatment
that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune is easily
transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune is tumor agnostic;
it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal
cancer. INKmune is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the
About INmune Bio Inc.
INmune Bio Inc. is a publicly
traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to
fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes
dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver
of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer's disease, Mild
Cognitive Impairment and treatment-resistant depression (XPro ). The Natural Killer Cell Priming Platform includes INKmune developed
to prime a patient's NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic
castration-resistance prostate cancer. The third program, CORDStrom, is a proprietary pooled, allogeneic, human umbilical cord-derived
mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis
bullosa. INmune Bio's product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer.
To learn more, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there
is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical
facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on
current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances
may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. CORDStrom,
XPro1595 (XPro ), and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved
by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the
FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ
materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability
to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations
and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research,
product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and
described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual
Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company
assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the
date of this release.
Co-founder and Chief Financial Officer
Head of Investor Relations