Full Press Release Details
INmune Bio Inc. Expands INKmune Trial in Prostate
First patient treated
in Phase II portion of clinical trial in metastatic prostate cancer at the West Los Angeles Veterans Administration Hospital
Boca Raton, Florida, Jan. 28, 2025 (GLOBE
NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology
company focused on developing treatments that harness the patient's innate immune system to fight disease, has an ongoing Phase
I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce the participation of
a patient at the West Los Angeles VA Medical Center in the trial. The participant received the investigational intervention, as an out-patient
per the protocol, under the care of Matthew Rettig, MD., Chief, Hematology-Oncology, VA Greater Los Angeles Healthcare System, Professor
of Medicine and Urology, Medical Director Prostate Cancer Program, David Geffen School of Medicine and the Jonsson Comprehensive Cancer
The VA Health Care System provides medical
care to the Veterans of the US military. Every year, approximately 15,000 Veterans are diagnosed and treated at the
VA for prostate cancer and over 200,000 Veterans are prostate cancer survivors. Under Rettig's leadership, 900 patients with prostate
cancer have participated in over two dozen clinical trials at the West LA VA Medical Center. The Care PC trial is the first using a NK
targeted biologic therapy. The Veteran received the "medium" dose of INKmune initiating the Phase II portion of the trial.
"The INmune Bio study represents a new
immune therapy approach to treating advanced prostate cancer. The study involves the use of cellular therapy treatment that activates
NK cells, which are immune cells known to target tumor cells and are in relative abundance in prostate cancer," said Rettig, Principal
Investigator, about the the CarePC program. "Unlike most immunotherapies, this study involves treatment that is given as an outpatient
and appears to have minimal side effects, which helps the management of prostate cancer among Veterans and the US population at large."
In 2022, Congress signed into law the Joseph
Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022, also known as the Cleland-Dole
Act. In response to the Cleland-Dole Act, which requires VA to make strides in prostate cancer care, the VA has published a prostate
cancer clinical pathway, which expressly considers incorporation of clinical trials, and patient educational materials, and
is in the process of creating a national prostate cancer registry. "The Veterans Health Administration is an ideal place to perform
clinical trials," said RJ Tesi MD, CEO of INmune Bio, "it is a large integrated health care system that provides high-quality
medical care to a diverse population of patients."
CaRe PC is an open label Phase I/II trial
that will test up to three dose levels of INKmune in men with mCRPC. INKmune is given in the out-patient setting via an
intravenous infusion three times in the first two weeks of treatment (days 1, 8 and 15). No pre-medication or additional cytokines are
needed for INKmune therapy. The patient is followed for six months with careful study of immunologic and anti-cancer responses to INKmune
treatment. Immune responses include changes in numbers of tumor killing memory-like NK cells in the patient's blood and how long
these specialized NK cells remain in the circulation. Anti-tumor responses will be monitored by following the level of prostatic surface
antigen (PSA) in the blood. Additionally, we will leverage Artificial Intelligence (AI) to quantify the number and size of metastatic
lesions using piflufolastat F 18 - a PSMA (prostate-specific membrane antigen) imaging agent developed by Lantheus marketed as Plarify
and by measuring circulating tumor DNA (ctDNA) in the blood. Up to 30 patients will receive one of three levels of dose of INKmune .
The study uses a novel modified Bayesian design
that allows for a 3x3 dose escalation design. Once the Phase I portion is complete, the doses that are safe will be tested simultaneously
in the Phase II portion of the trial. Up to 10 patients can be enrolled at each dose level. There are two primary goals of the trial.
The first is to demonstrate the safety of INKmune in the patient population, men with mCRPC. The second is to determine which dose
of INKmune should be used in a blinded, randomized registration trial. Determining the best dose of INKmune to use in future
clinical trials will depend on a combination of immunologic and anti-tumor responses seen in the men treated with INKmune therapy.
INKmune is an NK cell targeted therapy that
is not an NK cell. INKmune is a product designed to improve the function of the patient's own NK cells. INKmune is a patented,
pharmaceutical-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. These INKmune-primed NK 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
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 ), Early
Alzheimer's disease, 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 the 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 (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.
Chief Financial Officer
Head of Investor Relations