INmune Bio Inc. Presents Preclinical Data at SITC 2023 Showing INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα
30 Outubro 2023 - 10:07AM
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, is presenting data on the use of INB03, a
dominant-negative inhibitor of soluble TNF in the treatment of
high-risk MUC4 expressing HER2+ breast cancer. Roxana Schillaci
Ph.D. of Instituto de Biología y Medicina Experimental in Buenos
Aries, Argentina, will present her work at the 38th annual Society
of Immunotherapy in San Diego, California which runs from November
1-4.
The poster entitled “INB03: a new immune checkpoint
inhibitor that reprograms polarization and promotes ADCP in human
macrophages,” shows that INB03 is an innate immune checkpoint
inhibitor working through the SIRPα-CD47 pathway to promote ADCP.
SIRPα is a surface protein expressed by macrophages that binds to
CD47 expressed by tumor cells. SIRPα-CD47 is known as the “don’t
eat me” signal that prevents phagocytosis of tumor cells and
promotes resistance to immunotherapy. INB03 downregulates SIRPα
expression to eliminate the “don’t eat me signal” and promote ADCP.
Inhibition of the SIRPα-CD47 pathway has focused predominately on
targeting CD47 with anti-CD47 therapeutics. Targeting SIRPα may
provide differentiated pharmacokinetic, safety, and efficacy
profiles.
“Macrophages play an important role in the control of tumors,
but cancer cells have developed very efficient ways to evade attack
by the patient’s immune system,” said Roxana Schillaci, Ph.D.
of CONECIT and senior author of this work. “TNF promotes expression
of SIRPα on macrophages that bind to CD47 on tumor cells to prevent
ADCP. Neutralization of sTNF with INB03 downregulates the
expression of SIRPα to promote ADCP that should help control tumor
growth and prevent resistance to immunotherapy.”
The research presented in the poster examines
animal models and human macrophages. INB03 neutralizes sTNF,
repolarizing tumor protecting M2 macrophages to M1 anti-tumor
macrophages, enhances ADCP with trastuzumab, and reduces SIRPα
expression. In mice with trastuzumab resistant breast cancer, INB03
treatment polarizes splenic and tumor-infiltrating macrophages to
M1 type macrophages that phagocytize tumor cells and decreased
immune checkpoint expression (PD-L1, TIM3, LAG3) in
tumor-infiltrating CD8+ T cells.
RJ Tesi MD, CEO of INmune Bio, stated that, “a new therapeutic
strategy for treating cancer is to improve the function of
tumor-infiltrating macrophages. DN-TNF has been shown to improve
macrophage phagocytosis in models of AD, MS, DMD, and cancer.”
Microglia are tissue-based macrophages of the brain, while tumor
macrophages are the phagocytic cells of the tumor microenvironment
(TME). In disease, soluble TNF depresses macrophage phagocytic
function, resulting in neurodegeneration, synaptic dysfunction, and
demyelination in the brain or tumor growth and resistance to cancer
immunotherapy. DN-TNF neutralizes sTNF and returns phagocytic
function to normal. In neurodegenerative diseases, DN-TNF promotes
microglial phagocytic function to promote remodeling and repair by
decreasing neurodegeneration, improving synaptic plasticity, and
promoting remyelination. In cancer, DN-TNF repolarizes
immunosuppressive macrophages into tumor-killing
macrophages and promotes ADCP. In both cases, normalizing
phagocytic function should allow for therapeutic benefits.
Acronyms:DN-TNF: Dominant-Negative Tumor
Necrosis FactorsTNF: Soluble Tumor Necrosis FactorADCP: Antibody
Dependent Cellular PhagocytosisSIRPα: Signal-Regulatory Protein
AlphaTME: Tumor MicroenviornmentAD: Alzheimer’s
DiseaseMS: Multiple ScleroisisDMD: Duchenne Muscular
DystrophyCNS: Central Nervous System
About INB03
INB03 is a DN-TNF inhibitor that neutralizes
soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF) or
TNF receptors. Compared to currently available non-selective TNF
inhibitors, INB03 preserves the immune response to cancer by
decreasing immunosuppressive cells in the TME including TAM and
MDSC while promoting recruitment of anti-tumor immune cells
including cytolytic CD8+ lymphocytes, NK cells and anti-tumor
macrophages. INB03 has completed an open label dose-escalation
Phase I trial in patients with advanced cancer. In that trial,
INB03 was found to be safe and well tolerated - no dose limiting
toxicity was found. INB03 decreased blood biomarkers of
inflammation in patients with advanced cancer. INMB is planning a
Phase II trial that uses IN03 as part of combination therapy.
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.
INmune Bio Contact:
David Moss, CFO(858) 964-3720info@inmunenbio.com
Investor Contact:Jason Nelson, Core IR(516) 842-9614 x-823
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