INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in Patients with Metastatic Castration-Resistant Prostate Cancer
January 02 2024 - 8:00AM
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, dosed the first patient in the Phase
I/II trial in men with metastatic castration-resistant prostate
cancer (mCRPC) on December 27, 2023. INKmune™ is a biologic therapy
given as out-patient therapy without the need for
pre-medication or cytokine support.
“Results of immunotherapy trials for mCRPC have been
disappointing,” said Professor Matt Rettig, 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 Center. “After many failures using T-cell
focused immunotherapy approaches, targeting NK cells -- which are
abundant in the prostate cancer tumor microenvironment -- is a
promising and novel strategy. I am optimistic about the therapeutic
potential of INKmune, an off-the-shelf innate immune
therapy.” Professor Rettig was deeply involved in the design
of the clinical trial. Dr. Rettig’s statements should not be
construed as endorsement by the University of California.
CaRe PC is an open label Phase I/II trial that will test up to
three doses of INKmune™ in men with mCRPC. INKmune™ is given as
out-patient therapy via intravenous infusion three times in the
first two weeks of treatment (days 1, 8 and 15). 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, as well as using 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, and by measuring circulating tumor DNA
(ctDNA) in the blood. As many as 30 patients will receive one of
three levels of dose of INKmune™ (low, medium, high).
“There are two key elements for successful immunotherapy. There
must be immune cells in the tumor and the drug must convert those
immune cells into cancer killing cells,” said Prof. Mark Lowdell
Ph.D., CSO of INmune Bio and inventor of INKmune™. “Prostate cancer
has many resting NK cells, and we believe INKmune will convert
those resting NK cells into memory-like NK cells that can attack
the tumor.”
The study uses a novel modified Bayesian design. The sequential
Phase I dose escalation portion will be followed by a Phase II
trial that will simultaneously enroll patients in all dosing
cohorts. 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 will 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.
About INKmune™
INKmune is an NK cell targeted therapy that is not
an NK cell. INKmune™ 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. 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™), 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 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.
INmune Bio Contact:
David Moss, CFO (858) 964-3720 info@inmunebio.com
Investor Contact:
Jason Nelson Core IR (516) 842-9614 x-823
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