CAMBRIDGE, Mass. and
WESTMINSTER, Colo., May 12, 2021 /PRNewswire/ -- Leap
Therapeutics (Nasdaq: LPTX), a biotechnology company focused
on developing targeted and immuno-oncology therapeutics,
and Flagship Biosciences, the leader in data-centric
pathology and tissue analysis, today announced that they have
developed an image analysis RNAscope® assay that is
being used successfully for prospective patient enrollment in a
clinical trial. To the companies' knowledge, this is the first
example of an RNAscope assay using a digital image analysis
solution for patient enrollment. The findings were published in an
article, "Validation of a DKK1
RNAscope chromogenic in situ hybridization assay for gastric and
gastroesophageal junction adenocarcinoma tumors," on Monday, May 10 in Scientific Reports.
It can be viewed at https://rdcu.be/ckjl5.
Co-authored by a collaborative team from Leap Therapeutics,
Flagship Biosciences, and Athenaeum Pathology Consulting, the
article highlights how Leap is identifying patients likely to
benefit from DKN-01, its anti-Dickkopf-1 (DKK1) antibody, and Flagship's ability to
validate and implement complex biomarker assays using digital image
analysis. Leap and Flagship's work centered on the development and
validation of a DKK1 RNAscope
chromogenic in situ hybridization (CISH) assay and digital image
analysis solution. DKK1 is a secreted modulator of Wnt
signaling that is frequently overexpressed in tumors and associated
with a poor prognosis for patients. DKN-01 is a humanized
monoclonal therapeutic antibody that binds to and blocks the
activity of DKK1 and has demonstrated
clinical activity in gastric/gastroesophageal junction (G/GEJ)
adenocarcinoma patients with elevated tumoral expression of
DKK1 RNA. Leap and Flagship have
validated the DKK1 RNAscope assay and
accompanying digital image analysis solution as specific,
sensitive, accurate, and reproducible according to Clinical
Laboratory Improvement Amendments (CLIA) guidelines, and their
work is currently being applied to prospectively identify G/GEJ
patients with elevated tumoral expression of DKK1 for treatment with a DKN-01 plus
tislelizumab combination (Leap Therapeutics; NCT04363801).
Additionally, the companies are using the DKK1 RNAscope assay and digital image analysis
solution for a retrospective analysis of G/GEJ patients treated
with DKN-01 in combination with tislelizumab and
chemotherapy.
Biomarkers are increasingly prominent in drug development and
are often applied in clinical trial design to determine the
patients who are most likely to benefit from a specific therapeutic
or treatment regimen. To use a biomarker strategy to
prospectively identify patients, the biomarker test must be robust
and precise. Because of the challenges in manual
semi-quantification of RNAscope tissue staining, Leap and Flagship
developed the novel digital image analysis algorithm that
identifies tumor cells and quantifies DKK1 signal.
"A potential challenge with RNAscope is manual scoring, which
requires a pathologist to score the tissue at a high magnification
to visualize and count the number of stained dots that appear in
tumor cells," said Michael Kagey,
Ph.D., Senior Director of Translational Medicine at Leap
Therapeutics. "Since this can lead to slow, inaccurate, and
non-reproducible scoring, we worked with Flagship to develop a
digital algorithm. The digital algorithm reduces pathologist
time, potential variability from manual scoring and allows us to
reliably screen for patients who may benefit from our therapy."
In addition to the prospective screening of patients, the work
is also further advancing the companion diagnostic development of
the RNAscope assay and could generally be used as a guide for the
validation of RNAscope CISH assays with digital image
quantification.
"Our technology, combined with our scientific process and
pathology oversight allows you to quickly find the right patients
and get to your endpoints more rapidly," said Trevor Johnson, CEO of Flagship Biosciences.
"Image analysis also provides a superior return on investment by
saving time and helping get drugs to market more quickly. Our
ability to take a completely novel pathology approach and turn it
into a CLIA-validated diagnostic test to help our clients is
extremely gratifying."
"Our clinical development has been enhanced by the rapid,
prospective patient screening that has happened as a result of
using the DKK1 RNAscope CISH assay
and digital image analysis solution," said Douglas E. Onsi, President and CEO of Leap
Therapeutics. "As a result of the partnership between Leap and
Flagship, the patients who we believe will best benefit from our
drug are now being included in our trial. We look forward to
further collaborating with Flagship Biosciences."
About Leap Therapeutics
Leap
Therapeutics (Nasdaq: LPTX) is focused on developing targeted
and immuno-oncology therapeutics. Leap's most advanced clinical
candidate, DKN-01, is a humanized monoclonal antibody targeting the
Dickkopf-1 (DKK1) protein. DKN-01 is
in clinical trials in patients with esophagogastric, hepatobiliary,
gynecologic, and prostate cancers. Leap has entered into a
strategic partnership with BeiGene, Ltd. for the rights to develop
DKN-01 in Asia (excluding Japan), Australia,
and New Zealand. For more
information about Leap Therapeutics,
visit https://www.leaptx.com or view our public filings
with the SEC that are available via EDGAR
at https://www.sec.gov/ or
via https://investors.leaptx.com.
RNAscope® is a registered trademark
of Advanced Cell Diagnostics, Inc., Newark, CA, USA.
FORWARD-LOOKING STATEMENTS
This press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements include Leap's expectations with
respect to the development and advancement of DKN-01, including the
initiation, timing and design of future studies, enrollment in
future studies, potential for the receipt of future option
exercise, milestone, or royalty payments from BeiGene, and other
future expectations, plans and prospects. Although Leap believes
that the expectations reflected in such forward-looking statements
are reasonable as of the date made, forward-looking statements are
subject to known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially from our
expectations. Such risks and uncertainties include, but are not
limited to: that the initiation, conduct, and completion of
clinical trials, laboratory operations, manufacturing campaigns,
and other studies may be delayed, adversely affected, or impacted
by COVID-19 related issues; the accuracy of our estimates regarding
expenses, future revenues, capital requirements and needs for
financing; the outcome, cost, and timing of our product development
activities and clinical trials; the uncertain clinical development
process, including the risk that clinical trials may not have an
effective design or generate positive results; our ability to
obtain and maintain regulatory approval of our drug product
candidates; the size and growth potential of the markets for our
drug product candidates; our ability to continue obtaining and
maintaining intellectual property protection for our drug product
candidates; and other risks. Detailed information regarding factors
that may cause actual results to differ materially will be included
in Leap Therapeutics' periodic filings with the SEC,
including Leap's Annual Report on Form 10-K for the fiscal year
ended December 31, 2020, as filed with
the SEC on March 12, 2021 and as may be updated
by Leap's Quarterly Reports on Form 10-Q and the other reports Leap
files from time to time with the SEC. Any forward-looking
statement contained in this release speaks only as of its date.
Leap undertakes no obligation to update any forward-looking
statement contained in this release to reflect events or
circumstances occurring after its date or to reflect the occurrence
of unanticipated events.
About Flagship Biosciences
Founded in 2009
and headquartered in Westminster,
Colorado, Flagship Biosciences, Inc. is a technology-driven
tissue analysis services company delivering the most accurate and
informative data available. We are revolutionizing tissue analysis
to improve drug development and diagnostics using the power of AI
with a consultative approach. Our services and technology
dramatically improve on the data and interpretation from
traditional pathology methods, eliminating variability associated
with typical tissue assessments, and bringing new insights to
tissue analysis results. We provide expert scientific consultation
for every client. Our team interprets results, contextualizes
tissue biology, and identifies the best course for success.
https://flagshipbio.com/
For more information please contact:
For Leap Therapeutics:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
heather@argotpartners.com
Media Contact for Leap Therapeutics:
David Rosen
Argot Partners
212-600-1902
leap@argotpartners.com
For Flagship Biosciences:
Pamela Curran, Principal
Stratos Global Marketing
303-818-9316
pam@stratosglobalmarketing.com
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SOURCE Leap Therapeutics, Inc.