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
May 08 2023 - 8:00AM
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:
https://us06web.zoom.us/webinar/register/WN_nFfja42fQQieF4bwCiz4_g
About INKmune™
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.
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.
INmune Bio Contact:
David Moss, CFO (858)
964-3720info@inmunebio.com
Investor Contact:
Jason NelsonCore IR(516) 842-9614 x-823
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