Full Press Release Details
INmune Bio, Inc. Announces Submission of Investigational New Drug (IND)
Application for INKmune to the U.S. Food and Drug Administration for Treatment of Metastatic Castration-Resistant Prostate Cancer
BOCA RATON, Fla., April 03, 2023 (GLOBE NEWSWIRE) -- INmune Bio,
Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments
that harness the patient's innate immune system to fight disease, today announced that the Company has submitted an Investigational
New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of INKmune to treat metastatic castration-resistant
prostate cancer (mCRPC).
"We believe this IND highlights the potential for INKmune ,
our natural killer cell targeting immunotherapy, to treat solid tumors," said RJ Tesi M.D., CEO of INmune Bio. "We believe
INKmune provides a new treatment option that may allow men with mCRPC to safely avoid cytotoxic chemotherapy and potentially live
The trial is expected to take place in four or more medical centers
in the U.S and will enroll approximately 30 patients in a flexible Bayesian design. 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, will be Principal Investigator of the INKmune mCRPC trial. The goal of the trial is to define the safety of INKmune and
demonstrate the ability of INKmune-primed NK cells to attack prostate cancer. The results should allow us to choose the best dose of INKmune
to move into a blinded randomized trial. Given the novel nature of the treatment, the Company expects a period of consultation with the
FDA prior to initiating the planned trial.
"NK cells are often seen in prostate tumor biopsies, but in many
cases the cancer cells appear to be resistant to NK killing," said Mark Lowdell Ph.D., CSO of INmune Bio and inventor of the INKmune
technology. "The Company believes that INKmune can convert the patient's own NK cells into cancer killing memory-like
NK (mlNK) cells that can survive in the hostile immunosuppressive and hypoxic tumor microenvironment (TME) that as we have shown in
vitro, can kill NK-resistant prostate cancer cells."
The 6-month trial will test three doses of INKmune . The therapeutic
potential of INKmune in mCRPC will be tested in two ways. First, the immunologic effects of INKmune therapy will be measured
by the ability of INKmune to convert the patient's resting NK cells into cancer killing memory-like NK cells, the ability
of those cells to kill a tumor target (RAJI cell line) in vitro and the persistence of that response after treatment.
Second, the tumor response to INKmune therapy will be measured using traditional biomarkers of prostate cancer response - progression
free survival, changes in blood PSA level and imaging studies (bone and CT scan). Novel biomarkers of tumor response, change in PMSA PET
scan and circulating tumor DNA, will also be studied.
Currently, in INmune's ongoing Laurel INKmune trial, the
Company's MDS/AML INKmune Phase 1 program, the latest patient treated at the Royal Hallamshire Hospital at Sheffield
University Medical School finished INKmune treatment without side effects. Initial biomarker data from this patient show, as in
previous patients, that she has developed tumor killing memory-like NK cells in her peripheral blood one week after the first dose. Analysis
of her later blood samples is underway. The clinical sites continue to review patients for treatment in the Laurel trial. An
additional patient will be eligible for treatment in three weeks.
INKmune is an NK cell targeted therapy that is not an NK cell per
se but a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells in the patient
and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination; it is a pseudokine.
These INKmune-generated 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.
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 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 this release.
David Moss, CFO (858) 964-3720
(516) 842-9614 x-823