CAMBRIDGE, Mass., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported a business update and financial results for the second quarter ended June 30, 2018.

“Over the past few months, we have seen patients in the studies of both of our antibody programs experience clinical responses in combination with checkpoint inhibitors, including in patients who would not be expected to respond to checkpoint inhibitors alone. We look forward to continuing to read out data throughout the second half of 2018 from these ongoing clinical trials, including from our study evaluating DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric cancer at the European Society for Molecular Oncology (ESMO) Annual Meeting in October,” commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. “In addition, we recently announced a TRX518 collaboration with Pfizer and EMD Serono to add to our existing DKN-01 collaborations with Merck and Roche.”

Recent Highlights

Since the end of the first quarter, we have made substantial progress with the development of our product candidates:

• Presented clinical results from our study evaluating DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced esophagogastric cancer.

  • Combination has been well tolerated with no dose limiting toxicity.
  • In the high-dose DKN-01 cohort of dose escalation, two of four evaluable patients naïve to anti-PD-1/PD-L1 therapy have had a partial response, with two other evaluable patients having a best response of stable disease.
  – Both of the responding patients have a tumor phenotype which is typically less responsive to anti-PD-1 therapy.
  • Currently enrolling expansion cohorts in patients who are naïve to anti-PD-1/PD-L1 therapy and patients who are refractory to anti-PD-1/PD-L1 therapy.
  – The treatment-naïve cohort has passed the Simon Stage 2 threshold.
  – Enrollment of the full study is expected during the first quarter of 2019.
  • Additional data from this study will be presented at the ESMO 2018 Annual Meeting in October.

• Announced a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany to evaluate TRX518 in combination with BAVENCIO® (avelumab) and cyclophosphamide chemotherapy.

  • Under the terms of the collaboration, we will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers.
  • The study is expected to begin enrolling patients in the first quarter of 2019.

• Presented initial data from our clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab).

  • The first two patients treated with the higher dose of TRX518 in combination with KEYTRUDA have experienced clinical benefit after the end of two cycles of therapy.
  – Esophageal squamous cell carcinoma patient demonstrated a partial response with a 36% reduction in tumor volume.
  – Ocular melanoma patient experienced stable disease with a 23% reduction in tumor volume.
  • Seven patients have been treated with the lower dose of TRX518 in combination with OPDIVO.
  – Urothelial carcinoma patient who had progressed while on KEYTRUDA has had a partial response with a 39% reduction in tumor volume after the end of two cycles.
  – Four other patients experienced progressive disease, one patient was non-evaluable, and one patient has not yet had any on treatment disease evaluation.
  • Enrollment continues in the dose escalation phase for both the KEYTRUDA and OPDIVO combinations and in the dose expansion phase for the gemcitabine combination.

Selected Second Quarter 2018 Financial Results

Net loss was $7.4 million for the second quarter of 2018, compared to $6.9 million for the same period in 2017.

Research and development expenses were $4.2 million for the second quarter 2018, compared to $4.9 million for same period in 2017. The decrease of $0.7 million was primarily due to a decrease of $0.4 million in manufacturing costs related to clinical trial material, a decrease of $0.2 million in clinical trial costs and a decrease of $0.2 million in consulting fees associated with research and development activities. These decreases were partially offset by an increase of $0.1 million in stock based compensation expense.

General and administrative expenses were $2.6 million for the second quarter 2018, compared to $2.1 million for the same period in 2017. The increase of $0.5 million in general and administrative expenses was primarily due to a $0.4 million increase in legal, audit and consulting fees associated with corporate and business development activities and an increase of $0.1 million of stock based compensation expense.

Cash, cash equivalents and marketable securities totaled $30.5 million at June 30, 2018. Research and development incentive receivables totaled $1.8 million. The Company believes that its current cash and cash equivalents and the anticipated receipt of the research and development incentive receivable will be sufficient to fund the Company’s operating expenses into the fourth quarter of 2019.

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 cancer, biliary tract cancer, and gynecologic cancers, with an emerging focus on patients with defined mutations of the Wnt pathway and in combination with immune checkpoint inhibitors. 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 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/.