Full Press Release Details
Bio Inc. Patent Claims Covering INB16 Cell Line and INKmune Therapeutic Composition given Favorable Patentability Opinion by International
Bio receives International Search Report and Written Opinion communicating possession of novelty, inventive step, and industrial applicability
in all claims pending in an international patent application covering, among other things, its proprietary cell line, INB16, and the
INKmune therapeutic composition.
Raton, Florida, Oct. 31, 2023 (GLOBE NEWSWIRE) -- 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.
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 .
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."
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.
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.
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.
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).
American Type Culture Collection
EPO: European Patent Office
mlNK: memory-like NK cells
NK cell: Natural Killer cell
TME: Tumor Microenvirnoment
TpNK: Tumor Primed NK Cell
USPTO: United States Patent & Trademark Office
WIPO: World Intellectual Property Organization
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.
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.
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.
Jason Nelson, Core IR
(516) 842-9614 x-823