INmune Bio, Inc. Receives Health Canada “No Objection Letter” to Commence Clinical Trial of XPro1595 in Mild Alzheimer’s Disease
November 14 2022 - 9:00AM
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, today
announces that Health Canada has issued the Company a “No Objection
Letter” to proceed with the Company’s trial using XPro1595 to treat
mild Alzheimer’s Disease (AD) in Canada.
“We are pleased that Canada is now part of this
international Phase II trial,” said Dr. RJ Tesi, CEO of INmune
Bio. “Enrolling patients in both Canada and Australia gives
us access to a larger patient population that should help increase
the pace of enrollment. We hope to further expand the
geographical footprint of the trial soon.”
The first patient in the Phase 2 trial recently
completed all dosing and has enrolled in an open-label extension
study in Australia. While the Company continues to collaborate with
the FDA’s review of the trial to release its current hold and
initiate enrollment in the U.S., it is now working to setup sites
and enroll additional patients in Canada.
About XPro™
XPro™ is a next-generation inhibitor of tumor
necrosis factor (TNF) that is currently in clinical trial and acts
differently than currently available TNF inhibitors in that it
neutralizes soluble TNF (sTNF), without affecting trans-membrane
TNF (tmTNF) or TNF receptors. XPro™ could have potential
substantial beneficial effects in patients with neurologic disease
by decreasing neuroinflammation, improving axonal quality and
synaptic function while promoting remyelination. For more
information about the importance of targeting neuroinflammation in
the brain to improve cognitive function and restore neuronal
communication
visit this section of the INmune Bio’s website.
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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