INmune Bio Reports Positive Preliminary Data from INB03 Phase I Clinical Trial in Cancer
August 05 2019 - 9:01AM
INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on
developing treatments that harness the patient’s innate immune
system to fight disease, reported positive preliminary data today
during a presentation at Cambridge Healthtech Institute’s 7th
Annual Immuno-Oncology Summit in Boston. INB03 is being developed
as part of combination immunotherapy to potentially reverse
resistance to treatment.
The Phase I trial is an open-label, dose-escalation trial in
patients with advanced solid tumors. Patients received INB03, a
novel, second-generation soluble TNF (tumor necrosis factor)
inhibitor that works by a dominant-negative technology. Today,
positive preliminary data from the first two cohorts were released.
These data will be followed by a final report later this year as
the company advances the program into a Phase II study.
“The goal of the Phase I study is to determine, in order of
priority, the safety of INB03 in cancer patients, the dose of INB03
to take into the Phase II trials in cancer, and evidence of a
biologic effect of INB03,” said RJ Tesi, MD, Chief Executive
Officer and Chief Medical Officer of INmune Bio. “All of these
goals have been met. Using data from this trial, we have begun
planning a Phase II trial using INB03 as part of combination
immunotherapy in patients with cancer.”
To date, 11 of 12 patients have been enrolled in one of three
dosing cohorts of INB03 (0.3, 1.0 and 3.0 mg/kg). Participants were
a mix of patients with advanced solid tumors that have progressed
after multiple previous lines of therapy. INB03 was given once a
week by subcutaneous injection. Safety, INB03 pharmacokinetics and
inflammatory biomarkers were followed in all patients.
Preliminary data from patients treated in the first two cohorts
are available. Patients included two males and four females, and
the average age was 63-years-old. Patients in the study had
prostate cancer, ovarian cancer, colon cancer (two),
cholangiocarcinoma and lung cancer, with an average of three
previous lines of therapy (range: two to four). INB03 was given for
a median of 74 days (range: 12 to 119 days). No drug-related
serious adverse events have been reported, and INB03 was well
tolerated. Discontinuation of INB03 was due to tumor progression in
all patients. INB03 trough drug levels were obtained before each
INB03 dose. The target INB03 trough level was reached in three of
three patients in the 1.0 mg/kg group. The inflammatory cytokine
IL6, a biomarker of soluble TNF function, decreased by more than
50% in half of the patients, suggesting a pharmacodynamic effect of
INB03.
About INB03INB03, a novel dominant-negative TNF
inhibitor, is a selective second-generation TNF inhibitor that
neutralizes soluble TNF (sTNF) without blocking the function of
trans-membrane TNF or TNF receptors. In animal studies, INB03
neutralization of sTNF alters the immunobiology of the tumor
microenvironment (TME) to improve tumor killing by decreasing
populations of cells in the TME that protect the tumor from the
patient’s immune system and immunotherapy - myeloid derived
suppressor cells, T regulatory cells and tumor activated
macrophages. The unique mechanism of action suggests INB03 may have
safety and efficacy advantages over currently approved
non-selective TNF inhibitors in the treatment of cancer and other
diseases.
About INmune Bio, Inc.INmune Bio, Inc. is a
publicly traded (NASDAQ: INMB) clinical-stage biotechnology company
developing therapies targeting the innate immune system to fight
disease. INmune Bio is developing three product platforms that
reengineer the patient’s innate immune system’s response to
disease. In addition to INB03, INKmune is a natural killer (NK)
cell therapeutic that primes the patient’s NK cells to attack
minimal residual disease, the remaining cancer cells that are
difficult to detect, which often cause relapse. XPro1595 targets
neuroinflammation, which causes microglial activation, neuronal
cell death and synaptic dysfunction. XPro1595 is enrolling patients
in a Phase I trial in Alzheimer’s disease that is supported by a
$1M Part-the-Cloud Award from the Alzheimer’s Association. INmune
Bio’s product platforms utilize a precision medicine approach for
the treatment of a wide variety of hematologic malignancies, solid
tumors and neurodegenerative diseases. To learn more, please visit
www.inmunebio.com.
Safe Harbor
Statement
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. INBO3 is still in clinical trials and has not
been approved and there cannot be any assurance that it will be
approved. 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 for
the year ended December 31, 2018, 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
Media Contact: Antenna GroupHolly Dugan(201)
465-8019INmuneBio@AntennaGroup.com
Investor Contact: KCSA Strategic
Communications Valter Pinto / Scott Eckstein PH: (212)
896-1254 / (212) 896-1210INmune@KCSA.com
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