INmune Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune™ Therapeutic Composition given Favorable Patentability Opinion by International Search Authority
31 Octobre 2023 - 1:00PM
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, announced an update regarding the
company’s patent covering its proprietary cell line, “INB16”, as
well as the therapeutic composition comprising
replication-incompetent INB16 cells known as “INKmune™” and methods
of treating cancer by administering INKmune™, with a goal of
achieving in vivo priming of natural killer (NK) cells to enhance
the ability of a patient’s own NK-cells to effect cancer
surveillance, recognition, and killing.
In the written opinion for the international patent application
titled, “HUMAN T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA CELL LINE &
APPLICATIONS FOR TREATING CANCER,” an examiner from the
International Search Authority at the United States Patent &
Trademark Office, authorized by the World Intellectual Property
Organization under the Patent Cooperation Treaty, issued a
favorable patentability opinion with respect to novelty, inventive
step and industrial applicability of all claims and concluding that
the application contains patentable subject matter. The application
discloses and claims the novel INB16 cell line on deposit with the
American Type Culture Collection, as well as compositions
comprising replication incompetent INB16 cells (“INKmune™”) and
methods of treating cancer in patients by administering
INKmune™.
“Patents covering novel cell lines are somewhat rare in practice
and form a very small number of total patents issued,” said
Joshua Schoonover, Esq., in-house General Counsel for the Company.
“The company is exploring several potential commercial applications
of the INB16 cell line, including uses in cancer research, as well
as therapeutic uses, such as applications for treating various
cancer indications, or for enhancing other NK cell products to gain
advantages, such as improved avidity or memory-like functions.”
The Company intends to leverage the favorable written opinion
under the patent prosecution highway, a program offered by the
USPTO, EPO and other participating patent offices to accelerate
examination and ultimately patent issuance for inventions receiving
favorable opinions received from certain patent authorities,
including WIPO.
INB16 is a tumor cell line which is relatively insensitive to
killing by natural killer (NK) cells from healthy donors and from
patients. However, it carries molecules on its surface which bind
to critical activating ligands on resting NK (rNK) cells and, when
an rNK cell binds to INB16 the rNK becomes primed by the activating
ligands. One of the key molecules on the INB16 surface is called
CD15 and this binds to a ligand on rNK cells called CD2. Virtually
all rNK in the blood express CD2. The Company has shown that this
CD15-CD2 interaction is critical and has further mapped the
intracellular signaling cascade that it activates. During the next
16 hours after INB16 binding, the rNK becomes “primed” to form what
is called a “tumor-primed NK cell” – TpNK. These TpNK have the
characteristics of memory-like NK cells described by other groups
and which are produced in the lab by priming with a cocktail of
inflammatory cytokines (IL12/15/18). TpNK are a type of mlNK and
can kill tumor cells that are resistant to rNK cell-killing. This
means that they can kill a wide range of clinically relevant
cancers and leukemias. In addition, the Company’s in vitro data
shows that TpNK cells are able to overcome the immunosuppression of
hypoxia and regulatory cells in an active Tumor Microenvironment of
solid tumors. The Company is extending these findings to show that
INKmune-primed NK cells also overcome immunosuppressive cytokines
in the TME as a result of the NK differentiation into a memory-like
cell.
While INB16 can generate TpNK cells in vitro, it cannot be used
to treat NK cells in the blood of patients without being treated to
prevent it from further proliferation. To overcome this, the
Company uses novel methods to make the INB16 unable to replicate
and created a “replication-incompetent cell,” which forms a basis
of the biologic called “INKmune™.” The Company has safely treated
five patients with hematological cancers and shown that INKmune™
treatment converts patient’s normal resting NK cells into potent
memory-like NK cells much like those that can be produced in vitro.
More patients are awaiting trial enrolment. Administration of
INKmune may be the only way to create mlNK in vivo because the
cytokine cocktail used by others would be too toxic to use as a
direct treatment.
The Company opened an IND for a US trial of INKmune™ in
metastatic castration-resistant prostate cancer. The first site
will be initiated in the second week of November, meaning that
efforts are ahead of schedule for the planned first patient
treatment in this quarter. At least one other site is expected to
be opened before the end of the year. A clinical batch of INKmune™
has been manufactured for the first US cohort and is ready to be
shipped to a distribution center. Patients at each dose level will
receive all three doses of INKmune™ as an out-patient treatment
during the six-month trial. Two markers of INKmune™ efficacy will
be measured – immunologic activation and therapeutic efficacy as a
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).
Acronyms:ATCC: American Type Culture
CollectionEPO: European Patent OfficemlNK: memory-like NK cellsNK
cell: Natural Killer cellTME: Tumor MicroenvirnomentTpNK: Tumor
Primed NK CellUSPTO: United States Patent & Trademark
OfficeWIPO: World Intellectual Property Organization
About INKMUNE
INKmune™ is an investigational biologic substrate that can be
administered to a patient for in vivo priming of a patient’s own NK
cells. Cancerous cells occur regularly during the lifetime of a
healthy individual, but the individual’s NK cells generally
surveil, recognize, and often kill these cancerous cells before
they become a problem. Sometimes, however, cancer cells can
downregulate protein signals or otherwise hide from NK cells,
effectively evading killing. INKmune™, a therapeutic composition
comprising replication incompetent INB16 cells, is modified to
prevent proliferation in a patient’s body, but provides certain
signals necessary to stimulate or “prime” NK cells so that they can
achieve enhanced surveillance, recognition and killing of cancer
cells in a patient. 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 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
INmune Bio (NASDAQ:INMB)
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