WESTMINSTER, Colo. and
CAMBRIDGE, Mass., April 12, 2021 /PRNewswire/ -- Flagship
Biosciences, the leader in data-centric pathology and tissue
analysis, and Leap Therapeutics (Nasdaq: LPTX), a
biotechnology company focused on developing targeted and
immuno-oncology therapeutics, today announced a partnership to
use a clinically validated tumor expression assay utilizing
RNAscope® and tissue image analysis.
In a poster shared this week at the American Association for Cancer
Research (AACR) Annual Meeting 2021, the companies presented
data on the validation of a Dickkopf-1 (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. The companies have
demonstrated that the DKK1 RNAscope
assay and accompanying digital image analysis solution is specific,
sensitive, accurate and reproducible according to Clinical
Laboratory Improvement Amendments (CLIA) guidelines. The assay
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).
"CISH assays can be used for the interrogation of clinical
samples when protein targets are not sufficient," said Flagship
Biosciences CEO, Trevor Johnson.
"However, reading these assays can be challenging for pathologists.
At Flagship, our pathologist-driven image analysis generates unique
cellular data profiles that allow for the kind of robust
quantitative solution that Leap was looking for. Using our
proprietary image analysis technology and patented, cell-based
tissue analysis, we deliver the data-rich tissue interpretations to
support therapeutic development."
"This is a robust laboratory developed test (LDT) that is
superior to traditional DKK1
immunohistochemistry (IHC) by demonstrating improved specificity
and sensitivity," said Michael
Kagey, Ph.D., Senior Director of Translational Medicine.
"Furthermore, the use of the digital image analysis algorithm to
quantify DKK1 signal and support
pathologist interpretation is a novel approach that reduces the
risk of scoring bias."
To select patients for their clinical study, Leap Therapeutics
sends samples from the United
States and the Republic of Korea to Flagship's centralized
laboratory. Flagship conducts the RNAscope assay, image analysis,
data analysis, and in-house pathologist review, providing the
information needed to make clinical trial enrollment decisions.
"The DKK1 RNAscope LDT is an
integral component of our clinical development strategy," said
Douglas E. Onsi, President and CEO
of Leap Therapeutics. "The rapid sample turnaround time from
Flagship has allowed for the prospective screening of patients to
support enrollment. We look forward to our continued partnership
with Flagship."
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/
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.
For more information please contact:
For Flagship Biosciences:
Pamela Curran
Stratos Global Marketing
303-818-9316
pam@stratosglobalmarketing.com
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
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SOURCE Leap Therapeutics, Inc.