Full Press Release Details
INmune Bio, Inc. Announces FDA Clearance of
IND Application for INKmune , a Natural Killer Therapy, for a Phase I/II Trial in Metastatic Castration-Resistant Prostate Cancer
BOCA RATON, Fla., May 08, 2023 (GLOBE NEWSWIRE)
-- INmune Bio, Inc. (NASDAQ: INMB) announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational
New Drug (IND) application for INKmune , a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial
for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC). The Company believes this is the first NK immunotherapy
trial in men with mCRPC, which affects more than 80,000 men in the U.S. The trial is expected to enroll the first of 30 patients
in the second half of 2023. It will be opened at 4 more clinical study sites, with a goal to determine short and long-term safety
of INKmune , demonstrate the ability of INKmune to control prostate cancer tumor burden, and identify a dose of INKmune
to be used in a future blinded randomized pivotal trial.
The principal investigator of the clinical
trial is Prof. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen
School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer. Prof. Rettig is a consultant to INmune Bio. According
to RJ Tesi, MD, CEO of INmune Bio, "Prostate cancer is one of the few solid tumors that has no immunotherapy options and chemotherapy,
the standard-of-care, has suboptimal efficacy with measurable toxicities. INKmune has the potential to provide a safe and
effective therapeutic option for men with this difficult disease."
This will be the second clinical trial using
INKmune to treat cancer. The first trial, called Laurel, is an on-going Phase I trial in patients with high risk MDS or
AML. Mark Lowdell PhD, CSO of INmune Bio and inventor of the INKmune technology said, "There are compelling clinical
evidence demonstrating that men with prostate cancer have lots of NK cells in the blood and their tumor, but often these NK cells are
resting or immature NK cells that do not kill cancer. INKmune therapy can convert these inert NK into therapeutically relevant
and effective NK cells."
Patients will receive one of three doses of
INKmune as an out-patient treatment during the six-month trial. Two markers of INKmune efficacy will be measured -
immunologic and therapeutic efficacy. Immunologic efficacy will measure the increase in memory-like NK cells in the blood and how
long those cells are present in the patient's blood. Therapeutic efficacy will measure tumor response to INKmune therapy,
using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden
measured by bone and CT scan). Novel biomarkers of tumor response, PMSA PET scan and circulating tumor DNA, will also be studied.
The Company will host a Webinar entitled: INKmune
Primed NK cell Therapy for mCRPC on Friday, 12 May at 11 AM EDT on to discuss why INKmune is well suited for the treatment
of men with mCRPC and provide details of the clinical trial design. RJ. Tesi, MD will moderate a discussion between Prof. Matt
Rettig, MD and Prof. Mark Lowdell, PhD.
To register for the webinar, please sign-up
by clicking here or the link below:
INKmune is a product designed to improve
the function of the patient's own NK cells. INKmune is a clinical-grade, replication-incompetent human tumor cell
line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines
in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates
multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant
to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas,
myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require
any type of conditioning, pre-medication or cytokine support.
About INmune Bio, Inc.
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 two product platforms that are both in clinical trials: 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 cancer (INB03 ), 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. INmune Bio's product platforms utilize a precision medicine approach for the treatment of a wide
variety of hematologic and solid tumor malignancies, and chronic inflammation. 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. INB03 ,
XPro1595, 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
David Moss, CFO (858) 964-3720
(516) 842-9614 x-823