Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
announced that the first patient has been dosed in a Phase 1
clinical trial evaluating Leap’s GITR agonist, TRX518, in
combination with gemcitabine chemotherapy or in combination with
KEYTRUDA® (pembrolizumab) or Opdivo® (nivolumab), anti-PD-1
therapies marketed by Merck (known as MSD outside the United States
and Canada) or Bristol-Myers Squibb, respectively.
“TRX518 has demonstrated the ability to reduce immunosuppressive
regulatory T cells and to activate tumor-killing T effector cells
in clinical and preclinical studies. The combination of
TRX518 with anti-PD-1 immunotherapy has strong scientific rationale
and could act synergistically, enabling improved responses without
significant additional toxicity. We look forward to
evaluating the safety and efficacy of TRX518 in combination with
pembrolizumab or nivolumab,” commented Diwakar Davar, M.D.,
Assistant Professor of Medicine of the University of Pittsburgh and
an investigator on the study.
“There is strong preclinical evidence for synergistic efficacy
when combining immune activators targeting GITR with chemotherapy,”
commented Cynthia Sirard, M.D., Vice President, Clinical
Development of Leap Therapeutics. “This trial represents an
important step in our strategy to evaluate the combination activity
of TRX518 as a backbone immunotherapy."
The TRX518-003 study is a multipart study evaluating TRX518 as a
monotherapy and in combination with gemcitabine, KEYTRUDA®
(pembrolizumab), or Opdivo® (nivolumab) in patients with advanced
solid tumor malignancies.
The combination arms evaluating TRX518 with gemcitabine includes
both dose escalation and dose confirmation cohorts and are designed
to evaluate the safety, pharmacokinetics/pharmacodynamics, and
efficacy of the combination. The study will enroll patients who
have metastatic or locally advanced, incurable solid malignancies
for which gemcitabine is clinically appropriate (e.g., non-small
cell lung, breast, ovarian, pancreatic, and renal cancer). The
TRX518 + gemcitabine study will enroll approximately 32
patients.
The combination arms evaluating TRX518 with pembrolizumab or
nivolumab includes both dose escalation and dose confirmation
cohorts and are designed to evaluate the safety,
pharmacokinetics/pharmacodynamics, and efficacy of the
combinations. The study will enroll patients who have received
treatment with pembrolizumab or nivolumab for ≥4 months with a best
response of stable disease and plans to continue treatment in
accordance with package insert; or are not currently taking, but
eligible for treatment with, pembrolizumab or nivolumab in
accordance with the approved indications for each as referenced in
the package insert. The TRX518 + PD-1 antagonist study will enroll
approximately 64 patients.
About TRX518TRX518 is a humanized monoclonal
antibody with agonist activity targeting glucocorticord-inducible
TNF-superfamily receptor (GITR). TRX518 is engineered to enhance
immune responses to cancer. TRX518 is being studied in two ongoing
repeat-dose clinical trials in patients with advanced solid tumor
malignancies. Data from the trials have shown that patients
receiving TRX518 monotherapy achieved durable stable disease with
signs of pharmacodynamic activity including CD8+ T cell activation
and modulation of immunosuppressive regulatory T cells.
About Leap TherapeuticsLeap Therapeutics
(Nasdaq:LPTX) is 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 cancer and biliary tract cancer, with
an emerging focus on patients with defined mutations of the Wnt
pathway and in combinations with immune checkpoint inhibitors.
Leap’s second clinical candidate, TRX518, is a novel, humanized
GITR agonist monoclonal antibody designed to enhance the immune
system’s anti-tumor response that is in two advanced solid tumor
studies. For more information about Leap Therapeutics, visit
http://www.leaptx.com or our public filings with the SEC that are
available via EDGAR at http://www.sec.gov or via
http://www.investors.leaptx.com/.
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, TRX518, and other programs, including the initiation,
timing and design of future studies, enrollment in future studies,
business development, and other future expectations, plans and
prospects. Leap has attempted to identify forward looking
statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’
‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’
‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. 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 risks and uncertainties that could cause actual results
to differ materially from our expectations. These risks and
uncertainties include, but are not limited to: the accuracy of our
estimates regarding expenses, future revenues, capital requirements
and needs for financing; the ability to complete a financing or
form business development relationships to fund our expenses; 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; our
plans to research, develop, and commercialize our drug product
candidates; our ability to achieve market acceptance of our drug
product candidates; unanticipated costs or delays in research,
development, and commercialization efforts; the applicability of
clinical study results to actual outcomes; 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 Securities and Exchange
Commission (the "SEC"), including Leap Therapeutics’ Form 10-K
that Leap filed with the SEC on March 31, 2017. These statements
are only predictions and involve known and unknown risks,
uncertainties, and other factors. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
Opdivo® is a registered trademarks of Bristol Myers-Squibb.
CONTACT:
Douglas E. OnsiChief Financial OfficerLeap Therapeutics,
Inc.donsi@leaptx.com617-714-0360
Argot PartnersInvestor RelationsSusan Kim or Heather
Savelle212-600-1902susan@argotpartners.comheather@argotpartners.com
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