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Leap Therapeutics, Inc. (Nasdaq: LPTX) is a pioneering clinical-stage biopharmaceutical company focused on developing novel targeted antibody therapies for cancer treatment. Headquartered in Cambridge, Massachusetts, Leap Therapeutics aims to discover and advance transformative cancer treatments by targeting tumor-promoting pathways, cancer-specific cell surface molecules, and activating the immune system against cancer cells.
The company's lead program, DKN-01, is a humanized monoclonal antibody that targets Dickkopf-related protein 1 (DKK1). This promising candidate is in clinical trials for treating esophagogastric, gynecologic, and colorectal cancers. Another key program, FL-301, targets Claudin18.2-expressing cells and is being developed for gastric and pancreatic cancer treatments. Leap Therapeutics also has two preclinical antibody programs, FL-302 and FL-501, which are advancing toward developing innovative cancer therapies.
Operating as a single segment dedicated to oncology, Leap Therapeutics has established several strategic collaborations to enhance its development pipeline, including a clinical collaboration with BeiGene for the DisTinGuish trial and partnerships with NovaRock Biotherapeutics and Adimab. The company's dedication to advancing targeted and immuno-oncology therapeutics underscores its commitment to addressing unmet needs in cancer treatment. Leap's research and development activities continue to make significant progress, with ongoing clinical trials and new data demonstrating the potential efficacy and safety of its therapeutic candidates.
In recent news, Leap Therapeutics announced the completion of enrollment in the randomized controlled Part C of the DisTinGuish study, evaluating DKN-01 in combination with tislelizumab and chemotherapy for advanced gastroesophageal junction and gastric cancer. Additionally, the company reported financial results for the first quarter of 2024, highlighting a successful $40 million financing that extends its cash runway into the second quarter of 2026. This funding will support the expansion and continued execution of the DKN-01 development program, including the expansion of the randomized controlled Part B of the DeFianCe study in second-line colorectal cancer patients.
For more information about Leap Therapeutics, visit www.leaptx.com or view their public filings with the SEC available via EDGAR at www.sec.gov or www.investors.leaptx.com.
Leap Therapeutics (LPTX) has partnered with Flagship Biosciences to utilize a clinically validated DKK1 RNAscope assay for patient enrollment in their clinical trials. This assay aims to identify patients with high DKK1 levels in gastric cancers for treatment with DKN-01 and tislelizumab. Results presented at the AACR Annual Meeting 2021 confirm the assay's specificity and sensitivity, adhering to CLIA guidelines. The partnership underscores Leap's clinical development strategy, facilitating rapid patient screening and enhancing trial enrollment efficiency.
Leap Therapeutics (Nasdaq:LPTX) announced the completion of enrollment for the first-line patient cohort in the DisTinGuish study, evaluating DKN-01, an anti-Dickkopf-1 antibody, combined with tislelizumab for treating gastric or gastroesophageal junction cancer. The Phase 2a trial will enroll up to 72 patients and aims to address a significant unmet medical need. Initial data is expected in the second half of 2021. DKN-01 has received Orphan Drug and Fast Track Designations from the FDA, highlighting its potential in combating this deadly cancer.
Leap Therapeutics (Nasdaq:LPTX) presented promising clinical data from its Phase 2 trial of DKN-01 during the Society of Gynecologic Oncology 2021 Annual Meeting. The study showcased DKN-01's effectiveness as a monotherapy and in combination with paclitaxel for patients with advanced gynecological cancers. Key findings revealed a complete response lasting over 2.5 years and improved outcomes for patients with DKK1-high tumors. Enhanced efficacy was noted in endometrioid histology patients. Leap is encouraged to further explore DKN-01, highlighting its tolerability and potential for improved survival rates.
Leap Therapeutics (Nasdaq:LPTX) reported its financial results for 2020, revealing a net loss of $27.5 million, down from $32.9 million in 2019, primarily due to reduced R&D expenses. The company secured a $51.75 million public offering and signed a licensing agreement with BeiGene for DKN-01 in key Asia-Pacific regions. Key advancements include positive outcomes in EGC cancer for DKN-01 and receiving both Orphan Drug and Fast Track Designations from the FDA. Cash and equivalents stood at $52.1 million as of December 31, 2020, signaling a stable financial position for ongoing projects.
Leap Therapeutics, Inc. (Nasdaq:LPTX) announced that its CEO, Douglas E. Onsi, will present a corporate overview at two upcoming virtual investor conferences. The first is the Raymond James 42nd Annual Institutional Investors Conference on March 1, 2021 at 10 a.m. Eastern Time. The second is the H.C. Wainwright Global Life Sciences Conference from March 9-10, 2021, with a presentation available at 7:00 a.m. Eastern Time on March 9. Leap focuses on developing targeted and immuno-oncology therapeutics, with its leading candidate, DKN-01, in clinical trials for various cancers.
Leap Therapeutics (Nasdaq:LPTX) announced a corporate overview presentation at the H.C. Wainwright BioConnect 2021 Conference from January 11-14, 2021. Douglas E. Onsi, the company’s President and CEO, will present on January 11 at 6:00 a.m. Eastern Time. The presentation can be accessed on the company’s Investors page, with a replay available for a limited time. Leap is known for its immuno-oncology therapeutics, including the clinical candidate DKN-01, targeting various cancers.
Leap Therapeutics (Nasdaq:LPTX) announced that President and CEO Douglas E. Onsi will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 3:40 p.m. ET. The presentation will be available via webcast on the company's Investors page. Leap focuses on developing targeted and immuno-oncology therapeutics, with its lead candidate, DKN-01, currently in clinical trials for various cancers. The company has a strategic partnership with BeiGene for DKN-01's development in Asia, excluding Japan.
Leap Therapeutics (Nasdaq:LPTX) announced the publication of preclinical results regarding DKN-01 in Molecular Cancer Research. DKN-01, a monoclonal antibody blocking the DKK1 protein, showed positive effects in mouse cancer models including tumor growth inhibition. The studies indicated that DKN-01 can activate NK cells and reduce metastases, suggesting its potential effectiveness in combination with PD-1 inhibitors. Leap has also initiated trials combining DKN-01 with BeiGene's tislelizumab for patients with high DKK1 levels in gastroesophageal cancers.
Leap Therapeutics, Inc. (Nasdaq:LPTX) announced that CEO Douglas E. Onsi will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. A pre-recording of the chat is accessible on the company’s investors page, with a replay available for 90 days. Leap focuses on developing targeted and immuno-oncology therapeutics, with DKN-01 as their lead candidate, currently in clinical trials for various cancers. The company collaborates with BeiGene for DKN-01's development in Asia, Australia, and New Zealand.
Leap Therapeutics, Inc. (Nasdaq:LPTX) reported its Q3 2020 financial results, showing a net loss of $7.1 million, down from $7.9 million in Q3 2019. Key highlights include the first patient dosed in a Phase 2a study of DKN-01 in combination with BeiGene's tislelizumab for metastatic gastric cancer. The FDA granted Fast Track designation to DKN-01 for high DKK1 expression G/GEJ cancer. The company ended the quarter with $58 million in cash and marketable securities, highlighting effective cost management with R&D expenses at $5.4 million, down from $5.8 million year-over-year.
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