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About Leap Therapeutics
Leap Therapeutics, Inc. (Nasdaq: LPTX) is a clinical-stage biopharmaceutical company specializing in the development of targeted antibody therapies and immuno-oncology treatments for cancer. Operating at the forefront of oncology research, Leap Therapeutics focuses on creating innovative therapies that address unmet medical needs in treating specific cancer types. The company's work is grounded in cutting-edge science, targeting tumor-promoting pathways, cancer-specific cell surface molecules, and activating the immune system to combat cancer cells effectively.
Core Business Areas
The company's primary therapeutic focus is on monoclonal antibody development, with two advanced programs in clinical trials:
- DKN-01: A humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, which is implicated in tumor growth and immune suppression. DKN-01 is being developed for esophagogastric, gynecologic, and colorectal cancers through multiple clinical trials, including the DeFianCe and DisTinGuish studies.
- FL-301: A monoclonal antibody targeting Claudin18.2, a biomarker associated with gastric and pancreatic cancers. This program represents a novel approach to targeting specific cancer cell populations.
Additionally, Leap Therapeutics is advancing preclinical programs such as FL-302 and FL-501, which target Claudin18.2/CD137 and GDF15, respectively, to expand their portfolio of transformative cancer treatments.
Business Model and Market Position
Leap Therapeutics operates as a single-segment entity focused exclusively on oncology. The company generates revenue primarily through collaborations, licensing agreements, and partnerships with other biopharmaceutical companies. For instance, Leap collaborates with BeiGene, NovaRock, and Adimab to enhance its research and development capabilities. Leap's business model is heavily reliant on external funding, including private placements and institutional investments, to support its R&D activities and clinical trials. The company has successfully attracted partnerships with leading investors and organizations, underscoring its credibility in the biotech space.
Industry Context and Challenges
Leap Therapeutics operates in the highly competitive biotechnology and oncology sectors, characterized by rapid innovation and significant regulatory scrutiny. Key challenges include:
- High R&D costs and the inherent risks of clinical trial failures.
- Regulatory hurdles in gaining approvals for new therapies.
- Competition from other biotech firms specializing in targeted and immuno-oncology therapies.
However, Leap differentiates itself through its focus on biomarker-driven therapies, which aim to provide personalized treatment options for patients. By targeting specific cancer biomarkers like DKK1 and Claudin18.2, Leap positions itself as a pioneer in precision medicine within oncology.
Significance in Oncology
The company's innovative approach to cancer therapy has the potential to address critical gaps in the treatment of aggressive cancers. By leveraging advanced antibody technologies and focusing on tumor-specific pathways, Leap Therapeutics contributes to the broader goal of improving patient outcomes in oncology.
Conclusion
Leap Therapeutics is a key player in the biotechnology sector, with a strong focus on developing targeted and immuno-oncology therapeutics. Its commitment to addressing unmet medical needs in cancer therapy, coupled with its innovative pipeline and strategic collaborations, positions the company as a significant contributor to the advancement of oncology research. While challenges persist, Leap's biomarker-driven approach and focus on precision medicine underscore its potential to make a lasting impact in the fight against cancer.
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.
Leap Therapeutics (Nasdaq:LPTX) announced that its President and CEO, Douglas E. Onsi, will present a corporate overview at the Stifel 2020 Virtual Healthcare Conference from November 16-18, 2020. The presentation is scheduled for November 16 at 9:20 a.m. ET and will be available via live webcast on the company's Investors page. Leap is focused on developing targeted and immuno-oncology therapeutics, with its lead candidate, DKN-01, currently in clinical trials for various cancers. Further details on Leap can be found on their official website.
Leap Therapeutics (Nasdaq:LPTX) presented clinical data from its Phase 2 trial of DKN-01 for recurrent epithelial endometrial cancers at the AACR Virtual Conference on November 9-10, 2020. DKN-01, a monoclonal antibody targeting Dickkopf-1 (DKK1), showed efficacy in biomarker-selected patients, particularly those with Wnt signaling alterations. Key findings included a 10% overall response rate and improved outcomes in patients with Wnt activating mutations and high DKK1 expression. The study suggests DKN-01 offers a promising treatment option with a favorable safety profile.
Leap Therapeutics (Nasdaq: LPTX) announced promising results from a Phase 1b/2a clinical trial of DKN-01 for advanced esophagogastric cancer presented at the SITC 2020 Annual Meeting. The study revealed that patients with high tumoral DKK1 expression had superior clinical outcomes, including doubled median progression-free survival (PFS) and better overall survival (OS) rates, as compared to those with low DKK1 levels. These findings suggest that DKK1 expression could serve as a predictive biomarker, supporting further studies combining DKN-01 with anti-PD-1 therapies.
Leap Therapeutics, a biotechnology company, will present crucial data on its DKN-01 monoclonal antibody for esophagogastric cancer at the Society of Immunotherapy of Cancer's (SITC) 35th Annual Meeting, from November 9-14, 2020. Dr. Samuel J. Klempner will present findings that show DKK1 expression correlates with improved clinical outcomes in patients. DKN-01, recognized by the FDA with Orphan Drug and Fast Track designations, targets the Dickkopf-1 protein, crucial in tumor biology and immunosuppression.
Leap Therapeutics (Nasdaq:LPTX) announced that the FDA has granted Fast Track designation to its drug DKN-01 for treating gastric and gastroesophageal junction adenocarcinoma in patients whose tumors express high Dickkopf-1 (DKK1) protein after prior chemotherapy. This designation aims to expedite the drug's development and review, enabling faster access for patients with unmet medical needs. DKN-01 is also undergoing trials for various cancers and has received Orphan Drug Designation for gastric and gastroesophageal junction cancers.
Leap Therapeutics, a biotechnology firm listed on Nasdaq under LPTX, announced that its CEO, Douglas E. Onsi, will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020, at 3:00 p.m. Eastern Time. The presentation will be available via webcast on the company's Investors page. Leap is focused on developing targeted immuno-oncology therapeutics, with its leading candidate, DKN-01, in trials for various cancers.
Leap Therapeutics (Nasdaq: LPTX) has announced the expansion of its leadership team, appointing Jason S. Baum as Vice President, Head of Translational Medicine, and Christine M. Granfield as Vice President, Head of Regulatory Affairs and Quality. These appointments bring over 37 years of combined industry experience, with Baum's expertise in precision medicine and Granfield's extensive regulatory background expected to enhance Leap's development of its lead candidate, DKN-01, targeting various cancers. The company focuses on advancing innovative therapeutics in oncology.
Leap Therapeutics, Inc. (Nasdaq:LPTX) reported its Q2 2020 financial results, highlighting a net loss of $6.5 million, down from $8.4 million in Q2 2019. The company completed a $51.75 million public offering and presented positive DKN-01 clinical trial data, showing responses in endometrial and carcinosarcoma patients. DKN-01 received Orphan Drug Designation for gastric and gastroesophageal junction cancers, enhancing its development prospects. Cash and marketable securities stood at $64.9 million as of June 30, 2020.
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