INmune Bio, Inc. Announces Positive Solid Tumor Efficacy Data in Multiple Cancer Cell Lines for INKmune
October 19 2022 - 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,
announces positive solid tumor data in multiple cancer lines
resistant to NK killing that can be overcome with administration of
INKmune.
Solid tumors represent approximately 90% of adult human
cancers while the majority of cell therapies focus on the 10% of
cancers that are hematologic tumors, or “liquid tumors.” The
current data provides insights into why the Company believes that
INKmune arms Natural Killer (NK) to override immunosuppression and
hypoxia in an active Tumor Microenvironment (TME) to kill solid
tumors.
The interaction of the TME with cancer cells and immune cells
can drive tumor progression and prevent many cell therapies from
being effective. These complex interactions should be considered
when designing cell therapies to treat solid tumors. In
solid tumors, the TME is hostile to cell therapies because of (i)
the presence of immunosuppressive immunoregulatory cells, and (ii)
the low levels of oxygen (hypoxia). A cell therapy must
operate in this hostile environment to successfully treat solid
tumors,
INKmune converts patient’s normal resting NK (rNK) cells into
potent memory-like NK cells that target solid tumors directly, even
in the presence of immunosuppressive immunoregulatory cells and
hypoxia associated with the TME. The Company’s
pre-clinical data show that INKmune primes NK cells from patients
and from healthy donors to lyse NK-resistant ovarian (CaOva),
prostate (CaPros), renal (RCC) and nasopharyngeal (NPC) cancer
cells. When compared to rNK cells, which are normal NK cells
from healthy donors or patients before treatment with INKmune, the
INKmune primed NK cells demonstrated enhanced ability to kill these
resistant tumor cell lines.
The value in the tables is percent of tumor cells killed.
For instance, in the table below looking at laboratory assay using
healthy donor NK cells killing of a prostate cell line called
DU145, resting NK cells that have not been primed with INKmune kill
fewer than 4% of the DU145 cells in 4 hours. INKmune primed
NK cells kill approximately 66% of DU145 cells in the same amount
of time. Negative values mean that the tumor cells grew faster than
the NK cells could kill them.
Healthy donor NK cell responses to NK-resistant tumor cell
lines:
Tumor Target |
% Tumor Cell Lysis (rNK) |
% Tumor Cell Lysis (INKmune -primed NK) |
Improvement |
Prostate-DU145 |
3.87 |
66.17 |
+++ |
RCC-786O |
-2.09 |
50.19 |
+++ |
RCC-ACHN |
-5.03 |
34.75 |
+++ |
CaOva-SKOV3 |
12.32 |
28.50 |
++ |
NPC-H3 |
6.61 |
45.86 |
+++ |
NPC-C17 |
0.50 |
31.04 |
+++ |
Cancer patient NK cell responses to NK-resistant tumor cell
lines:
Patient ID |
Tumor target |
% Tumor Cell Lysis (rNK) |
% Tumor Cell Lysis (INKmune -primed NK) |
Improvement |
CaOva1 |
SKOV3 |
7.00 |
43 |
+++ |
CaOva2 |
SKOV3 |
4.00 |
50 |
+++ |
CaOva3 |
SKOV3 |
8.00 |
64 |
+++ |
RCC1 |
768O |
36.40 |
32.3 |
- |
RCC2 |
768O |
10.20 |
21 |
+ |
RCC3 |
768O |
20.70 |
19.6 |
- |
RCC4 |
768O |
0.00 |
40 |
+++ |
RCC5 |
768O |
19.80 |
47 |
+ |
RCC6 |
768O |
20.30 |
50 |
+ |
RCC7 |
768O |
16.90 |
54.4 |
++ |
RCC8 |
768O |
50.00 |
64.4 |
+ |
RCC9 |
768O |
14.20 |
32.7 |
+ |
The Company identified more than1,500 proteins that are
upregulated in NK cells following INKmune priming and subsequent
analysis compared them to NK cells primed with a cytokine cocktail
of IL-12, IL-15 and IL-18. Of the 250 most upregulated
proteins, 141 are completely unique to INKmune priming and are not
upregulated by the cytokines IL-12, IL-15 and IL-18. Many of these
unique proteins are involved in cell survival and the enhanced
metabolism likely to protect INKmune primed NK cells in the TME.
“We believe the upregulation of key proteins associated with
enhanced metabolic fitness and mitochondrial repair in the NK cells
are critical for NK survival in the TME of solid tumors,” said Dr.
Mark Lowdell, the Company’s CSO.
There remains an unmet need for novel treatments in prostate,
renal and nasopharyngeal cancers. The number of patients who
could benefit exceeds 4 million annually in the US alone.
These data support INmune Bio’s decision to transition
INKmune trials into the treatment of solid tumors.
The company presented the data at the Innate Killer Summit
Europe on October 19th. A video of the presentation
will be uploaded to the company’s website by Wednesday next
week.
About INKmune™
INKmune™ is a proprietary 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, ovarian cancer, breast cancer and the solid tumors shown
above.
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)
964-3720DMoss@INmuneBio.com
Investor Contact:Jason NelsonCore IR(516) 842-9614
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