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Leap Therapeutics Shares Skip Higher on Positive Preliminary Data From Gastric Cancer Study

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Shares of Leap Therapeutics Inc. traded 38% higher after the company reported positive preliminary data from the Phase 2a DisTinGuish Study of DKN-01 plus tislelizumab at the European Society for Medical Oncology Congress.

Biotechnology company Leap Therapeutics Inc. (LPTX:NASDAQ), which concentrates its work on the development of targeted and immuno-oncology therapeutics, today announced "the presentation of updated positive data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.'s (BGNE:NASDAQ; 06160:HKEX) anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) Congress."

The company pointed out that it recently reported positive initial data from the Phase 2a DisTinGuish study on September 13, 2021. Those published results were from 25 gastric or gastroesophageal junction (G/GEJ) cancer patients in the study that demonstrated that DKN-01 together with tislelizumab and chemotherapy as a first-line therapy was well tolerated with compelling activity.

Leap Therapeutics noted that the results it presented today at the ESMO Congress included "additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression." The company advised that the additional data it released today suggests that "responses to treatment are independent of PD-L1 expression, with 79% ORR in patients with PD-L1 low (CPS < 5) tumors."

Samuel Klempner, M.D., Faculty Member at Massachusetts General Hospital Cancer Center and Harvard Medical School, remarked, stated, "Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient's PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1…Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers."

The report indicated that the Phase 2a DisTinGuish study (NCT04363801) was designed to evaluate "DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma."

The DisTinGuish study is split into two parts and is presently underway in the U.S. and the Republic of Korea. The company advised that in Part A, which has already been completed, it enrolled 25 first-line HER2- G/GEJ cancer patients whose tumors expressed either high or low levels of DKK1. Part B of the study calls for the enrollment of up to 48 patients who have been diagnosed with second-line, DKK1-high G/GEJ cancer.

Leap noted some of the key findings in the study thus far and stated that "among patients who received a full cycle of DKN-01 therapy, the objective response rate (ORR) was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients." Additionally, "among patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients and for patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients."

The company advised that it will be hosting a conference call at 8:00 a.m. EDT on Friday, September 17, 2021 to discuss the initial results from the study in greater detail.

The call is scheduled to include Leap's executive management staff along with Dr. Jaffer Ajani of the M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital. Anyone interested may access the teleconference by calling (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international) using the conference passcode 1729397. The presentation will be also be webcasted live on Leap's investors page on its website.

Leap Therapeutics is a biotechnology company based in Cambridge, Mass. that is engaged in developing targeted and immuno-oncology therapeutics. The company's monoclonal antibodies are created and structured to target key cellular pathways that enable cancer to grow and proliferate. This process, known as cancer cell signaling, aids the body's immune system to identify and combat cancer.

The firm stated that "its 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 listed that it formed a partnership with BeiGene Co., Ltd (BGNE) for the rights to develop DKN-01 in Australia, New Zealand, and Asia (except for Japan).

Leap Therapeutics began the day with a market cap of around $115.2 million with approximately 59.7 million shares outstanding and a short interest of about 3.8%. LPTX shares opened more than 24% higher today at $2.40 (+$0.47, +24.35%) over yesterday's $1.93 closing price. The stock has traded today between $2.24 and $2.75 per share and is currently trading at $2.66 (+$0.73, +37.82%).


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