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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 has completed enrollment of 188 patients in Part B of the DeFianCe study, evaluating DKN-01 for second-line treatment of advanced colorectal cancer (CRC). The study combines DKN-01, an anti-Dickkopf-1 antibody, with standard bevacizumab and chemotherapy. Dr. Cynthia Sirard, Chief Medical Officer, highlighted the enthusiasm for DKN-01's potential, citing encouraging data from Part A showing clinically meaningful response rates and durable tumor reductions.
The Phase 2, open-label, global study's primary endpoint is progression-free survival (PFS), with an additional focus on PFS in left-sided CRC patients. Secondary objectives include objective response rate, duration of response, and overall survival. Initial data from Part B is expected in mid 2025.
Leap Therapeutics (LPTX) reported Q2 2024 financial results, highlighting progress in its oncology pipeline. Key developments include:
1. Increased overall response rate (ORR) to 33% in the DeFianCe study for colorectal cancer.
2. Expanded Part B of DeFianCe study to 180 patients, with enrollment expected to complete by September 2024.
3. Ongoing patient follow-up in DisTinGuish study for gastroesophageal cancer, with data expected in Q4 2024 or early 2025.
4. Completed $40 million private placement with investors including Gilead Sciences.
Financial highlights: Net loss increased to $20.4 million, primarily due to higher R&D expenses of $17.9 million. Cash and cash equivalents stood at $78.5 million as of June 30, 2024, expected to fund operations into Q2 2026.
Leap Therapeutics, Inc. reported financial results for Q1 2024, highlighting a $40 million private placement financing, completion of enrollment in key studies, and positive clinical data. The company's cash runway extends to Q2 2026, with plans for continued program expansion and major clinical milestones. Financially, net loss decreased to $13.8 million, research and development expenses dropped, and cash and cash equivalents stood at $54.9 million at the end of March 2024.
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