NEWARK, Calif., Oct. 26, 2021 /PRNewswire/ -- Protagonist
Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company")
today announced that it will receive a $7.5
million milestone payment from Janssen Biotech, Inc.
(Janssen) triggered by the completion of the clinical data
collection-related Phase 1 activities for PN-235 (JNJ-2113). This
investigational drug candidate is one of the three IL-23 receptor
antagonists that are part of Protagonist's collaboration agreement
with Janssen, which provides for concurrent development of multiple
oral IL-23 receptor antagonists against a broad range of
indications.
"The completion of these Phase 1 activities reflects our
continued strength of execution as our collaboration of four-plus
years, encompassing three assets in parallel development for
multiple indications, continues to make steady progress," said
Dinesh Patel, PhD, President and
Chief Executive Officer at Protagonist. "This latest milestone
marks $87.5 million in total
milestones we have earned to date through this strategic
partnership with Janssen. Our teams are guided by a shared
commitment to improving and expanding therapeutic options for the
many patients who may one day benefit from the oral therapies we
are advancing in development today."
This collaboration provides for the concurrent development of
multiple oral IL-23 receptor antagonists against a broad range of
both IBD (inflammatory bowel disease) and non-IBD indications that
can be treated through blockade of the IL-23 pathway. The compounds
currently in development are PTG-200, an oral IL-23 receptor
antagonist in Phase 2 development for the treatment of Crohn's
disease (CD), and PN-232 and PN-235, two second-generation oral
IL-23 receptor antagonist candidates. PN-232 and PN-235 are
currently in Phase 1 clinical development. Future milestones for
Phase 2 and Phase 3 successes are contemplated in the collaboration
agreement, as are royalties for Protagonist on products from this
portfolio that achieve market approval and entry.
Janssen Biotech, Inc., part of the Janssen Pharmaceutical
Companies of Johnson & Johnson, has exclusive, worldwide rights
to develop and commercialize PTG-200, PN-232, PN-235 and any other
second-generation compounds derived from this research
collaboration. Protagonist will have the right to co-detail up to
two licensed products in ulcerative colitis and CD in the U.S.
market.
About Protagonist Therapeutics
Protagonist Therapeutics is a biopharmaceutical company
with multiple peptide-based investigational new chemical entities
in different stages of development, all derived from the Company's
proprietary technology platform. Protagonist's pipeline includes
rusfertide (PTG-300), an investigational, injectable hepcidin
mimetic which is currently in Phase 2 development for the treatment
of polycythemia vera and hereditary hemochromatosis. The
Company is also evaluating an orally delivered, gut-restricted
alpha-4-beta-7 integrin specific antagonist peptide (PN-943)
currently in a Phase 2 study in adults with moderate to severe
active ulcerative colitis (UC). The Company is targeting ulcerative
colitis as the initial indication. In addition, Protagonist
has a worldwide license and collaboration agreement with Janssen
Biotech, Inc., for the development of oral peptide IL-23 receptor
antagonists. Compounds included in this agreement are PTG-200,
PN-235 and PN-232. PTG-200 is an orally delivered interleukin-23
receptor specific antagonist peptide which is currently in Phase 2
development for Crohn's disease. PN-235 and PN-232, both
second-generation oral interleukin-23 receptor antagonist
candidates, are currently in Phase 1 studies. For further
information, please visit www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This press release 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 our intentions or current expectations
concerning, among other things, the Company's clinical
collaboration with Janssen and the potential of collaboration
compounds. In some cases, you can identify these statements by
forward-looking words such as "anticipate," "believe," "may,"
"will," "expect," or the negative or plural of these words or
similar expressions. Forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties
that could cause actual results and events to differ materially
from those anticipated, including, but not limited to our ability
to develop and commercialize our product candidates, our ability to
earn milestone payments under our collaboration agreements, the
impact of the current COVID-19 pandemic on our discovery and
development efforts, our ability to use and expand our programs to
build a pipeline of product candidates, our ability to obtain and
maintain regulatory approval of our product candidates, our ability
to operate in a competitive industry and compete successfully
against competitors that have greater resources than we do, and our
ability to obtain and adequately protect intellectual property
rights for our product candidates. Additional information
concerning these and other risk factors affecting our business can
be found in our periodic filings with the Securities and
Exchange Commission, including under the heading "Risk Factors"
contained in our most recently filed periodic reports on Form 10-K
and Form 10-Q filed with the Securities and Exchange
Commission. Forward-looking statements are not guarantees of future
performance, and our actual results of operations, financial
condition and liquidity, and the development of the industry in
which we operate, may differ materially from the forward-looking
statements contained in this press release. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements, whether as a result of
new information, future events or otherwise, after the date of this
press release.
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