Leap Therapeutics Announces an Investigator-Initiated Study of DKN-01 in Patients with DKK1+ Advanced Prostate Cancer


CAMBRIDGE, Mass., Jan. 14, 2019 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing
targeted and immuno-oncology therapeutics, today announced an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the
Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with
advanced prostate cancer. This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castrationresistant
prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels.


"DKK1 can promote prostate cancer growth through suppressing the anti-tumor immune response. We have discovered that DKK1 is
upregulated in the substantial portion of advanced prostate cancers that lack expression of androgen receptor," commented Dr. Wise.
"Patients with this type of prostate cancer have a very poor prognosis and may benefit from this new immunotherapy strategy targeting
DKK1 therapy with DKN-01."


"An important part of our DKN-01 development strategy is to target biomarker-selected patient populations," said Cynthia Sirard, M.D.,
Vice President, Clinical Development of Leap Therapeutics. "In our esophagogastric cancer study, we have identified DKK1 levels
measured by RNAScope as a potential predictor of response to DKN-01-based therapy. We are looking forward to treating mCRPC
patients with elevated DKK1 levels in this study, building on our and Dr. Wise's work."


The study is expected to begin enrolling patients in the first quarter of 2019. mCRPC patients who have progressed on one or more
androgen receptor (AR) therapies (Xtandi or Zytiga) will be screened for DKK1 elevation in their plasma or in a tumor sample. Up to 97
patients will be enrolled in a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC patients who have not received prior
taxane chemotherapies will be treated with DKN-01 and docetaxel. DKN-01 will be given as a monotherapy to DKK1+ mCRPC patients
who have progressed on or refused docetaxel treatment.


About Prostate Cancer


Prostate cancer is the leading type of non-skin cancer in the US, and the second leading cause of cancer worldwide. Approximately 1 in 9
men will be diagnosed with prostate cancer at some point in their lives. Androgen receptor (AR)-targeted therapy can be highly effective for
the treatment of prostate cancer. Unfortunately, most patients will eventually develop resistance and progress to castration-resistant
prostate cancer (CRPC), an incurable form of the disease.


Disclosure


Dr. Wise is compensated to serve as a consulant to Leap Therapeutics. Also, Dr. Wise's involvement in this upcoming study does not
constitute an institutional endorsement from NYU Langone Health or its Perlmutter Cancer Center of the drug DKN-01 being studied.

 

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's second clinical candidate,
TRX518, is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in
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 https://www.leaptx.com/investors.


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 regarding Leap's expectations with respect to the development and advancement of DKN-01 and TRX518,
including the initiation, timing, design and results of future studies, enrollment in future studies, business development, 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: 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 February 23,
2018. 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.

 


CONTACT:


Leap Therapeutics, Inc.
Douglas E. Onsi
Chief Financial Officer
donsi@leaptx.com

617-714-0360


Argot Partners
Investor Relations
Heather Savelle
212-600-1902
heather@argotpartners.com

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