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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 (Nasdaq:LPTX) has announced the enrollment of the first patient in Part C of the Phase 2 DisTinGuish study, which evaluates DKN-01, an anti-DKK1 antibody, combined with BeiGene's tislelizumab and chemotherapy in patients with gastric or gastroesophageal junction cancer. The study aims to enroll 160 patients and assess progression-free survival, particularly in patients with high DKK1 expression. Positive preliminary data indicate promising response rates and survival outcomes surpassing benchmarks, marking a significant step in DKN-01's clinical development.
Leap Therapeutics, Inc. (Nasdaq: LPTX) will present updated data from Part B of the DisTinGuish Study evaluating DKN-01 combined with tislelizumab for DKK1-high GEJ/G cancer patients at the SITC 37th Annual Meeting in Boston from November 8-12, 2022. Additionally, preclinical data supporting the DeFianCe Study of DKN-01 in advanced colorectal cancer will also be shared. DKN-01, a humanized monoclonal antibody targeting DKK1, is being developed for multiple cancer types, with a strategic collaboration with BeiGene for development rights in Asia, excluding Japan.
Leap Therapeutics, Inc. (Nasdaq: LPTX) announced that CEO Douglas E. Onsi will participate in a fireside chat at the Baird 2022 Global Healthcare Conference in New York on September 13-14, 2022. The chat is scheduled for September 13 at 3:10 p.m. Eastern Time and will be webcast live, with a replay available on the company’s website. Leap specializes in developing targeted and immuno-oncology therapeutics, notably its candidate DKN-01, which targets the DKK1 protein and is currently in clinical trials for various cancers.
Leap Therapeutics (NASDAQ: LPTX) announced the appointment of Richard L. Schilsky, MD, to its Board of Directors, effective September 1, 2022. Dr. Schilsky has over 40 years of experience in cancer research and drug development, previously serving as Chief Medical Officer of ASCO. His expertise is expected to enhance Leap's drug development strategy, particularly for DKN-01, a monoclonal antibody aimed at treating solid tumors. The company continues to advance its pipeline and aims to deliver impactful therapies.
Leap Therapeutics, Inc. (NASDAQ: LPTX) announced promising results from its DisTinGuish study for DKN-01 combined with tislelizumab and CAPOX in first-line gastric cancer, showing a median progression-free survival of 11.3 months. The study demonstrated favorable outcomes for DKK1-high and PD-L1-low subgroups. Additionally, the WAKING study, evaluating DKN-01 with Tecentriq, is ongoing. Safety profiles were consistent, with high overall response rates, particularly in DKK1-high patients. Leap aims to advance DKN-01's clinical development, enhancing treatment standards for advanced gastroesophageal cancers.
Leap Therapeutics, Inc. (NASDAQ: LPTX) reported its Q2 2022 financial results, highlighting significant advancements in clinical trials for its lead product DKN-01. The company initiated Part C of the DisTinGuish study, evaluating DKN-01 alongside BeiGene's tislelizumab in G/GEJ cancer patients. Additionally, a new study in second-line colorectal cancer and an investigator-initiated trial with pembrolizumab were announced. Leap ended Q2 with $90.9 million in cash, providing a financial runway into mid-2024. Net loss for the quarter was $17.0 million, up from $9.5 million a year earlier, primarily due to rising clinical trial costs.
Leap Therapeutics, Inc. (Nasdaq:LPTX) announces the transition of Board member Dr. Monica Bertagnolli, recently appointed as the 16th Director of the National Cancer Institute (NCI), marking the first woman to hold this position since 1937. Effective immediately, Dr. Bertagnolli steps down from Leap's Board, following a commendable tenure. The company expresses pride in her achievement, recognizing her significant contributions to cancer research and leadership. Leap Therapeutics focuses on immuno-oncology therapeutics, notably developing DKN-01 for various cancers in partnership with BeiGene, Ltd.
Leap Therapeutics, in collaboration with BeiGene, announced the initiation of Part C of the DisTinGuish study, evaluating DKN-01 plus tislelizumab and chemotherapy in first-line gastric cancer patients. The study targets about 160 HER2-negative patients whose tumors express high DKK1 levels. Leap is also launching a second-line colorectal cancer trial with DKN-01 and bevacizumab, and supporting a trial in endometrial cancer with pembrolizumab. The company hosted an R&D Day to discuss these advancements and highlight strong preliminary results from previous trials.
Leap Therapeutics, Inc. (Nasdaq: LPTX) has announced a virtual R&D Day scheduled for July 12, 2022, at 12:00 pm ET. The event will feature the executive management team along with key opinion leaders discussing new data related to their lead candidate, DKN-01, a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Attendees can access a live webcast via the company's Investors page, where a replay will also be available.
Leap Therapeutics, Inc. (Nasdaq: LPTX) announced that initial clinical data from a Phase 1b/2a study of its anti-DKK1 antibody, DKN-01, will be presented at the ASCO Annual Meeting on June 6, 2022. The study evaluates DKN-01 as a monotherapy and in combination with docetaxel for metastatic castration-resistant prostate cancer (mCRPC). Key findings include no dose-limiting toxicities in any cohort and confirmed partial responses in all patients receiving the combination therapy, particularly in aggressive variant prostate cancer cases.
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