Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today announced that it
received an Issue Notification from the U.S. Patent and Trademark
Office for a patent related to the treatment of gastrointestinal
(GI) disorders through targeted delivery of JAK inhibitors for its
NaviCap™ targeted oral delivery platform under development.
US Patent Application No. 17/313,339, entitled “Treatment of a
Disease of the Gastrointestinal Tract with a JAK Inhibitor and
Devices,” will issue as US Patent No. 11,857,669 on January 2,
2024. The patent is directed to methods of treating a GI disease by
delivering a therapeutically effective amount of a JAK inhibitor at
a desired location in the GI tract, where the therapeutically
effective amount of the JAK inhibitor is less than an amount that
is effective when the JAK inhibitor is administered systemically.
The patent covers many JAK inhibitors, including those that are
approved or in development for a range of indications.
“This is another big IP win for us, as it encompasses the novel
treatment paradigm of our BT-600 program, which is designed to use
targeted delivery of a JAK inhibitor to potentially achieve better
therapeutic effect in ulcerative colitis, at lower doses than those
required with systemic delivery,” said Adi Mohanty, Chief Executive
Officer of Biora Therapeutics. “We are eager to prove this out as
we initiate our phase 1 trial for BT-600 shortly.”
The NaviCap ingestible device platform is protected by a patent
portfolio consisting of 30 patent families, including 86 granted
patents and 81 pending applications. Included in the NaviCap
portfolio are 34 granted patents and 6 pending applications
directed to the device’s proprietary autonomous localization
technology and to various therapeutic targets for the treatment of
inflammatory bowel disease, including, but not limited to, Janus
kinases (JAK), TNF-alpha, integrins, chemokines, IL-12/23, S1P, and
IL-10 inhibitors, and the delivery of antibodies, peptides, small
molecules, nucleic acids, stem cells, bacterial yeast, or phages to
the gastrointestinal tract. Biora’s total corporate portfolio
consists of 73 patent families, including approximately 190 issued
patents and 135 pending applications filed in major jurisdictions
around the world, including the US, Europe, China, Japan, South
Korea, Israel, Australia, Canada, and Mexico.
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 recently received
FDA clearance for its Investigational New Drug (IND) application to
begin a phase 1 study for BT-600.
About Biora TherapeuticsBiora Therapeutics 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 is focused on development of two therapeutics platforms:
the NaviCap™ targeted oral delivery platform, which is designed to
improve outcomes for patients with inflammatory bowel disease
through treatment at the site of disease in the gastrointestinal
tract, and the BioJet™ systemic oral delivery platform, which is
designed to replace injection for better management of chronic
diseases through needle-free, oral delivery of large molecules.
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 and research collaboration plans and expectations 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,”
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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,
clearance, or acceptance of our clinical trials or 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, 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, 2022 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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