Palisade Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement with Giiant Pharma, Inc. for Multiple Oral Drug Candidates Targeting Inflammatory Bowel Disease
06 Setembro 2023 - 9:45AM
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the
“Company”), a biopharmaceutical company advancing therapies for
acute and chronic gastrointestinal (GI) complications, today
announced that it has entered into a licensing agreement with
Giiant Pharma, Inc. (“Giiant”). The license provides the Company
with the exclusive worldwide rights to develop, manufacture and
commercialize Giiant’s proprietary targeted prodrug platform
focused on therapies for the multi-billion dollar IBD market. The
licensed technologies include Giiant’s precision delivery
technology platform and multiple product candidates, including the
lead asset in development, GT-2108, an orally administered,
gut-restricted, colon-specific phosphodiesterase-4 (PDE4) inhibitor
prodrug in development for patients affected by moderate-to-severe
ulcerative colitis. The license also includes the rights to
GT-1908, which is anticipated to be developed by the Company as a
second program, targeting fibro stenotic Crohn’s Disease by means
of an oral PDE4 compound.
Under the terms of the license, Palisade
obtained the rights to develop, manufacture, and commercialize all
compounds from Giiant, existing now and in the future, and any
product containing or delivering any licensed compound, in any
formulation or dosage for all human and non-human therapeutic uses
for any and all indications worldwide. Pursuant to the terms of the
license, Palisade will pay a portion of the development costs until
the first approval of an IND or CTA (Canadian clinical trial
approval), and will thereafter assume all development,
manufacturing, and commercialization costs. Additionally, per the
license, Palisade will pay (i) certain milestone payments (in cash
or stock at Palisade’s election) and (ii) royalty payments based on
sales.
“We are incredibly pleased to enter into this
licensing agreement with Giiant and transform our GI-focused
development pipeline. With current IBD therapies achieving minimal
rates of efficacy, there remains a strong need for orally
administered, novel solutions that overcome the limitations of
current biological medications. We believe the unique mechanism of
lead program GT-2108, which enables it to achieve highly localized
GI activity, coupled with an established regulatory pathway,
provides a unique partnering opportunity in the IBD space.
Additionally, this utilizes the capacity of our experienced team,
and adds multiple value-driving milestones in the near and long
term,” commented J.D. Finley, Chief Executive Officer of Palisade
Bio. “This transaction underscores our commitment to our corporate
mission of improving gastrointestinal health and represents an
exciting acceleration in our focus to advance innovative
therapeutics for the treatment of IBD.”
“Supported by external validation and funding by
the US Crohn’s and Colitis Foundation, we strongly believe in the
potential of our technology platform and the opportunity to address
the unmet medical needs in the treatment of IBD. Palisade Bio has
an established GI-focused mission, experienced leadership team and
strong balance sheet representing the perfect synergistic partner
to take our technology and oral IBD assets to the next level. We
look forward to working alongside the Palisade Bio team to advance
the development of these important programs and realize their full
potential,” added Christophe Mellon, Ph.D., Giiant’s Chief
Executive Officer.
As previously announced by Giiant, the
development of GT-2108 is supported by a $500,000 grant received
from the US Crohn’s and Colitis Foundation, through its IBD
Ventures program.
About
Giiant
Pharma,
Inc.Giiant Pharma
(www.giiant.com), a preclinical-stage biotech company, designs
gut-restricted small molecule, drug therapeutics with various
biological targets in gastroenterology owing to its proprietary
Precision Delivery technology platform. Its first lead program
GT-2108 is a microbiota-activated PDE4 inhibitor prodrug, with
vastly improved drug tolerability and enhanced therapeutic
effect.
About Palisade
Bio Palisade Bio is a biopharmaceutical company
focused on developing therapeutics that protect the integrity of
the intestinal barrier. The Company utilizes over three decades of
research and established science that links the role of intestinal
barrier biology with human disease to advance novel therapeutics
that target and improve the integrity of the intestinal
barrier.
The Company believes that addressing the
disruption of the intestinal barrier can fundamentally change the
way diseases are treated and establish new standards of patient
care. For more information, please go
to www.palisadebio.com.
Forward Looking StatementsThis
communication contains “forward-looking” statements for purposes of
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include statements
regarding the Company’s intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things:
the extent of our cash runway; our ability to successfully develop
our licensed technologies; estimates about the size and growth
potential of the markets for our product candidates, and our
ability to serve those markets, including any potential revenue
generated; future regulatory, judicial, and legislative changes or
developments in the United States (U.S.) and foreign countries and
the impact of these changes; our ability to build a commercial
infrastructure in the U.S. and other markets; our ability to
compete effectively in a competitive industry; our ability to
identify and qualify additional manufacturers to provide API and
manufacture drug product; our ability to enter into commercial
supply agreements; the success of competing technologies that are
or may become available; our ability to attract and retain key
scientific or management personnel; the accuracy of our estimates
regarding expenses, future revenues, capital requirements and needs
for additional financing; our ability to obtain funding for our
operations; our ability to attract collaborators and strategic
partnerships; and the impact of the COVID-19 pandemic on our
business, and operations, and supply. Any statements contained in
this communication that are not statements of historical fact may
be deemed to be forward-looking statements. These forward-looking
statements are based upon the Company’s current expectations.
Forward-looking statements involve risks and uncertainties. The
Company’s actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, the Company’s ability to advance its
clinical programs, the uncertain and time-consuming regulatory
approval process; and the Company’s ability to achieve additional
financing to fund future operations. Additional risks and
uncertainties can be found in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2022, filed with the
Securities and Exchange Commission (“SEC”) on March 22, 2023 as
well as the Company’s Quarterly Report on Form 10-Q, for the six
months period ended June 30, 2023, filed with the SEC on August 10,
2023. These forward-looking statements speak only as of the date
hereof and the Company expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in the Company’s expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
Palisade Bio Investor Relations ContactJTC
Team, LLC Jenene Thomas 833-475-8247 PALI@jtcir.com
Giiant Pharma ContactChristophe Mellon, PhD
CEO, Giiant Pharma 418-440-7232 christophe@giiant.com
Source: Palisade Bio
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