Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced that it has
been awarded a group of US and European patents related to several
additional therapeutic targets for its NaviCap™ targeted oral
delivery platform under development.
The patents are directed to methods of treating ulcerative
colitis using an ingestible device that delivers one or more
therapeutic agents to the proximal part of the large intestine. The
patents cover a range of therapeutic targets, including Janus
kinase (JAK) inhibitors, integrins, chemokines, IL-12/23 and IL-10
inhibitors, and, in some cases, cover the delivery of antibodies,
peptides, small molecules, nucleic acids, stem cells, bacteria,
yeast, or phages to the gastrointestinal tract.
The European Patent Office has issued European Patent No.
EP3554539B1 entitled “Treatment of a disease of the
gastrointestinal tract with an integrin inhibitor,” European Patent
No. EP3554485B1 entitled “Treatment of a disease of the
gastrointestinal tract with a JAK inhibitor and devices,” European
Patent No. EP3601531B1 entitled “Treatment of a disease of the
gastrointestinal tract with live biotherapeutics,” European Patent
No. EP3600416B1 entitled “Treatment of a disease of the
gastrointestinal tract with an immune modulatory agent released
using an ingestible device,” and European Patent No. EP3554541B1
entitled “Treatment of a disease of the gastrointestinal tract with
a chemokine/chemokine receptor inhibitor.” In addition, the
European Patent Office intends to grant European Publication No.
EP3554540A1 entitled “Treatment of a disease of the
gastrointestinal tract with an IL-12/IL-23 inhibitor released using
an ingestible device.”
The U.S. Patent and Trademark Office has issued US Patent No.
11,597,762 entitled “Treatment of a disease of the gastrointestinal
tract with an IL-12/IL-23 inhibitor released using an ingestible
device,” US Patent No. 11,426,566 entitled “Treatment of a disease
of the gastrointestinal tract with a TLR modulator,” US Patent No.
11,523,772 entitled “Treatment of a disease of the gastrointestinal
tract with an immunosuppressant,” and US Patent No. 11,596,670
entitled “Treatment of a disease of the gastrointestinal tract with
IL-10 or an IL-10 agonist.”
“The NaviCap platform has the potential to transform treatment
options for many diseases of the gastrointestinal tract by enabling
more effective delivery of therapeutics directly to the site of
disease in the intestine,” said Adi Mohanty, Chief Executive
Officer of Biora Therapeutics. “These patents expand our coverage
for additional therapeutic targets as we continue to strengthen our
intellectual property portfolio.”
The NaviCap ingestible device platform utilizes a unique and
proprietary device localization technology protected under 34
granted or allowed patents and applications and 6 pending
applications in major jurisdictions around the world, including the
US, Europe, China, Japan, South Korea, Israel, Australia and
Mexico. These patents are part of Biora’s larger corporate
portfolio consisting of 73 patent families, including approximately
180 issued patents and 145 pending applications.
About the NaviCap™ Targeted Oral Delivery Platform and
BT-600 Biora's NaviCap targeted oral therapeutics
platform utilizes a novel approach that could improve patient
outcomes by enabling delivery of therapeutics directly to the site
of disease, increasing therapeutic levels in tissue while reducing
systemic uptake. For the 1.8 million patients in the United States
who suffer from inflammatory bowel disease (IBD), existing
therapeutics offer less than ideal efficacy, likely because of the
challenges with safely achieving sufficient drug levels in the
affected tissues. Research has shown that targeted delivery of
therapeutics has the potential to improve patient outcomes in
IBD.
The NaviCap platform uses an ingestible device designed for
targeted delivery of therapeutics to improve treatment of IBD. Once
swallowed, Biora’s GItrac™ autolocation technology enables the
device to autonomously identify targeted locations in the GI tract
and release a therapeutic dose of up to 500µl.
Biora’s BT-600 program consists of a unique, liquid formulation
of tofacitinib delivered to the colon via the NaviCap device, for
the treatment of ulcerative colitis. Studies in healthy volunteers
have demonstrated accurate localization and delivery in a
fasted state and demonstrated the device’s ability to
function in both fasted and fed states, making it potentially the
first ingestible therapeutic delivery device that does not require
fasting or other food restriction for use. A device function study
in participants with active ulcerative colitis (UC) also
demonstrated successful device performance in active UC patients.
The company plans to submit an Investigational New Drug (IND)
application to begin a Phase 1 study with its BT-600 program during
the second half of 2023.
About Biora TherapeuticsBiora Therapeutics is
the biotech company that is reimagining therapeutic delivery. By
creating innovative smart pills designed for targeted drug delivery
to the GI tract, and systemic, needle-free delivery of
biotherapeutics, the company is developing therapies to improve
patients’ lives. Biora envisions a world where patients have access
to needle-free drug delivery and better therapeutic outcomes.
For more information, visit bioratherapeutics.com or follow the
company on LinkedIn or Twitter.
Safe Harbor Statement or Forward-Looking
StatementsThis press release contains “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995, which
statements are subject to substantial risks and uncertainties and
are based on estimates and assumptions. All statements, other than
statements of historical facts included in this press release,
including statements concerning the progress and future
expectations and goals of our research and development and clinical
efforts, are forward-looking statements. In some cases, you can
identify forward-looking statements by terms such as “may,”
“might,” “will,” “objective,” “intend,” “should,” “could,” “can,”
“would,” “expect,” “believe,” “design,” “estimate,” “predict,”
“potential,” “plan,” “target,” or the negative of these terms, and
similar expressions intended to identify forward-looking
statements. These statements reflect our plans, estimates, and
expectations, as of the date of this press release. These
statements involve known and unknown risks, uncertainties and other
factors that could cause our actual results to differ materially
from the forward-looking statements expressed or implied in this
press release. Such risks, uncertainties, and other factors
include, among others, our ability to innovate in the field of
therapeutics, our ability to make future filings and initiate
clinical trials on expected timelines or at all, our ability to
obtain and maintain regulatory approval or clearance of our
products on expected timelines or at all, our plans to research,
develop, and commercialize new products, the unpredictable
relationship between preclinical study results and clinical study
results, our expectations regarding allowed patents or intended
grants to result in issued or granted patents, our expectations
regarding opportunities with current or future pharmaceutical
collaborators, our ability to raise sufficient capital to achieve
our business objectives, the ongoing COVID-19 pandemic, and those
risks described in “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our
Annual Report on Form 10-K for the year ended December 31, 2021
filed with the SEC and other subsequent documents, including
Quarterly Reports, that we file with the SEC.
Biora Therapeutics expressly disclaims any obligation to update
any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
law.
Investor ContactChuck PadalaManaging Director,
LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390
Media Contactmedia@bioratherapeutics.com
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