CAMBRIDGE, Mass. and
BEIJING, Sept. 21, 2020 /PRNewswire/ -- Leap
Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused
on developing targeted and immuno-oncology therapeutics, and
BeiGene, Ltd., (Nasdaq:BGNE; HKEX: 06160), a commercial-stage
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today announced that the first
patient has been dosed in the DisTinGuish study, a Phase 2a
clinical trial evaluating Leap's investigational anti-Dickkopf-1
antibody (DKK1), DKN-01, in
combination with tislelizumab, BeiGene's anti-PD-1 antibody, with
or without chemotherapy, in patients with gastric or
gastroesophageal junction cancer (G/GEJ).
"Dosing of the first patient in the DisTinGuish study is a key
milestone for the DKN-01 development program," said Cynthia Sirard, M.D., Chief Medical Officer of
Leap Therapeutics. "We are excited to have the opportunity to
combine DKN-01 with tislelizumab due to the promising signals in a
DKK1 biomarker-defined population of
esophagogastric cancer patients. We look forward to working closely
alongside BeiGene to evaluate this potential new
combination therapy for a patient population with a high global
unmet medical need."
The DisTinGuish trial (NCT04363801) is a Phase 2a,
nonrandomized, open-label, multicenter study of DKN-01 in
combination with tislelizumab with or without chemotherapy as
first-line or second-line therapy in adult patients with
inoperable, locally advanced G/GEJ adenocarcinoma. The study, which
will be conducted in two parts, is expected to enroll up to 72
patients.
Part A will enroll up to 24 patients with G/GEJ adenocarcinoma
who have received no prior systemic treatment in the locally
advanced/metastatic setting (first-line treatment), and Part B will
enroll up to 48 patients with previously treated, inoperable,
locally advanced or metastatic DKK1-high G/GEJ adenocarcinoma (second-line
treatment). The study is designed to evaluate safety, tolerability,
and efficacy of the combination therapy of intravenous DKN-01 and
tislelizumab ± CAPOX (capecitabine + oxaliplatin) in G/GEJ
adenocarcinoma patients. Treatment will be conducted in repeating
21-day cycles until the patient meets pre-established criteria
for discontinuation or is no longer deriving clinical benefit. Part
A and Part B of the study will be conducted concurrently.
Leap is conducting this combination study in the United States as part of an exclusive
option and license agreement with BeiGene for the development of
DKN-01 in Asia (excluding
Japan), Australia and New
Zealand. Leap retains exclusive rights for the development,
manufacturing and commercialization of DKN-01 for the rest of the
world.
About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and
blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin
signaling, a signaling pathway frequently implicated in
tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell
signaling and in mediating an immuno-suppressive tumor
microenvironment through enhancing the activity of myeloid-derived
suppressor cells and downregulating NK ligands on tumor cells.
DKN-01 has received Orphan Drug Designation for the treatment of
gastric and gastroesophageal junction cancer from the U.S. Food and
Drug Administration.
About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody
specifically designed to minimize binding to FcγR on macrophages.
In pre-clinical studies, binding to FcγR on macrophages has been
shown to compromise the anti-tumor activity of PD-1 antibodies
through activation of antibody-dependent macrophage-mediated
killing of T effector cells. Tislelizumab is approved by the China
National Medical Products Administration (NMPA) as a treatment for
patients with classical Hodgkin's lymphoma who received at least
two prior therapies and for patients with locally advanced or
metastatic urothelial carcinoma (UC) with PD-L1 high expression
whose disease progressed during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
In addition, three supplemental new drug applications (sNDAs)
for tislelizumab have been accepted by the Center for Drug
Evaluation (CDE) of the NMPA and are under review – for
first-line treatment of patients with advanced squamous non-small
cell lung cancer (NSCLC) in combination with chemotherapy, for
first-line treatment of patients with advanced non-squamous NSCLC
in combination with chemotherapy, and for previously treated
unresectable hepatocellular carcinoma.
Tislelizumab is not approved for use outside of China.
About gastric / gastroesophageal junction cancer
Gastric adenocarcinoma (gastric cancer) remains one of the most
common and deadly cancers worldwide, especially among older
malesi. Based on GLOBOCAN 2018 data, stomach cancer is
the 5th most common neoplasm and the
3rd most deadly cancer, with an estimated 783,000
deaths globally in 2018i. Ninety-five percent of cancers
of the stomach are adenocarcinomas i. Gastric
cancer incidence and mortality are highly variable by region and
highly dependent on diet and Helicobacter
pylori infectioni. The gastroesophageal junction
(GEJ) is the area where the esophagus and stomach join together.
Given its anatomic location, GEJ adenocarcinomas have often been
grouped together with either esophageal or gastric cancers in
clinical trials.
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, a Wnt pathway modulator. DKN-01 is in clinical trials in
patients with esophagogastric, hepatobiliary, gynecologic, and
prostate cancers. Leap has entered into a collaboration 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
http://www.leaptx.com or view our public filings with the SEC that
are available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company
focused on discovering, developing, manufacturing, and
commercializing innovative medicines to improve treatment outcomes
and access for patients worldwide. Our 4,200+ employees in
China, the United States, Australia, Europe, and elsewhere are committed to
expediting the development of a diverse pipeline of novel
therapeutics. We currently market two internally discovered
oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in
the United States and China, and anti-PD-1 antibody tislelizumab in
China. We also market or plan to
market in China additional
oncology products licensed from Amgen Inc., Celgene Logistics Sàrl,
a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn
more about BeiGene, please visit www.beigene.com and follow us on
Twitter at @BeiGeneUSA.
LEAP FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995, which involve risks and
uncertainties. These statements include statements relating to
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, milestones 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, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's
Quarterly Reports on Form 10-Q and the other reports we file from
time to time with the SEC. Any forward-looking statements contained
in this release speak only as of its date. We undertake no
obligation to update any forward-looking statements contained in
this release to reflect events or circumstances occurring after its
date or to reflect the occurrence of unanticipated events.
BEIGENE FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
plans for the advancement of, anticipated clinical development and
regulatory milestones, and the potential opportunity of DKN-01 and
tislelizumab as a combination therapy. Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including BeiGene's
ability to demonstrate the efficacy and safety of its drug
candidates; the clinical results for its drug candidates, which may
not support further development or marketing approval; actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and marketing approval; BeiGene's
ability to achieve commercial success for its marketed products and
drug candidates, if approved; BeiGene's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; BeiGene's reliance on third parties to conduct drug
development, manufacturing and other services; BeiGene's limited
operating history and BeiGene's ability to obtain additional
funding for operations and to complete the development and
commercialization of its drug candidates; the impact of the
COVID-19 pandemic on the Company's clinical development, commercial
and other operations, as well as those risks more fully discussed
in the section entitled "Risk Factors" in BeiGene's most recent
quarterly report on Form 10-Q, as well as discussions of potential
risks, uncertainties, and other important factors in BeiGene's
subsequent filings with the U.S. Securities and Exchange
Commission. All information in this press release is as of the date
of this press release, and BeiGene undertakes no duty to update
such information unless required by law.
LEAP CONTACTS:
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
BEIGENE CONTACTS:
Investor Relations
Craig West
+1 857-302-5189
ir@beigene.com
Media Relations
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com
i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444111/
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SOURCE Leap Therapeutics, Inc.