Leap Therapeutics

Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline

5 hours ago

• Vyloy (zolbetuximab) has emerged as the first approved Claudin 18.2-targeted therapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma, marking a significant milestone in precision oncology. • The global Claudin 18.2 therapy market is rapidly expanding with over 60 drug candidates in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates. • China has become a major innovation hub for Claudin 18.2-targeted therapies, with companies like Innovent, MabWorks, and Biotheus leading development efforts as research expands beyond gastric cancers to other solid tumors.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Leap Therapeutics' FL-501 Shows Promise in Reversing Cancer Cachexia in Preclinical Studies

a month ago

• Leap Therapeutics' novel GDF-15 neutralizing antibody FL-501 demonstrated superior efficacy in preclinical models, fully restoring body composition and reversing key indicators of cancer cachexia. • The antibody showed a 2-3-fold longer half-life and 50% reduced clearance compared to competing therapies, positioning it as a potential best-in-class treatment for the devastating condition. • With no effective treatments currently available for cancer cachexia, Leap Therapeutics plans to advance FL-501 into clinical trials by 2026, potentially addressing a significant unmet medical need.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies

3 months ago

• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease. • Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials. • Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.

Sirexatamab Shows Promise in Colorectal Cancer, Fails to Meet Endpoints in Gastric Cancer

4 months ago

• Leap Therapeutics' DeFianCe study showed a 35% objective response rate (ORR) in second-line colorectal cancer (CRC) patients treated with sirexatamab, bevacizumab, and chemotherapy. • DKK1 levels were highly correlated with clinical activity in CRC patients, suggesting sirexatamab's mechanism is effective in this biomarker-defined population. • The DisTinGuish study in gastric cancer did not meet its primary endpoints, leading Leap to discontinue Phase 3 development in this indication. • Leap plans to initiate a Phase 3 registrational study for sirexatamab in second-line CRC, focusing on biomarker-selected populations.

Leap Therapeutics Halts Gastric Cancer Program After Phase 2 Trial Disappointment

4 months ago

Leap Therapeutics has announced the discontinuation of its late-stage development plans for sirexatamab in gastric cancer following disappointing Phase 2 trial results. The company's stock experienced a significant 63% decline in premarket trading following the announcement, marking a major setback in their oncology pipeline.

Evorpacept Shows Promise in HER2-Positive Gastric Cancer: Updated ASPEN-06 Data

4 months ago

• ALX Oncology's ASPEN-06 Phase 2 trial evaluates evorpacept, a CD47-blocker, in HER2-positive advanced gastric cancer patients who have been previously treated. • Updated data from the ASPEN-06 trial were presented at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI). • The virtual event hosted by ALX Oncology on January 23, reviewed the ASPEN-06 data, focusing on evorpacept's potential in immuno-oncology. • The ASPEN-06 trial is a phase 2/3 study of evorpacept in patients with HER2-overexpressing gastric/gastroesophageal cancer.

China NMPA Approves Astellas' Zolbetuximab for Advanced Gastric and GEJ Adenocarcinoma

5 months ago

• China's NMPA has approved zolbetuximab (VYLOY™) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. • Zolbetuximab is the first monoclonal antibody approved in China that targets the CLDN18.2 biomarker expressed in gastric tumor cells. • Approval was based on Phase 3 GLOW and SPOTLIGHT trials, showing statistically significant improvements in progression-free and overall survival. • Approximately 35% of Chinese patients with advanced gastric and GEJ cancers have tumors expressing the CLDN18.2 biomarker.

Claudin 18.2-Targeted Therapies Show Promise in Gastric and Other Cancers

6 months ago

• Claudin 18.2 (CLDN18.2) is a highly selective biomarker abnormally expressed in gastric, gastroesophageal junction, ovarian cancers, and some solid tumors, making it a target for cancer therapies. • Vyloy (zolbetuximab) gained approval in major markets like the US, EU, and Japan, as a first-line treatment with chemotherapy for HER2-negative G/GEJ adenocarcinoma expressing Claudin18.2. • Over 60 Claudin 18.2-targeting drugs are in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates, showing promise in various cancers. • Companion diagnostics, such as Roche's Ventana CLDN18 (43-14A) RxDx Assay, are crucial for identifying patients most likely to benefit from Claudin18.2-targeted therapies, improving treatment outcomes.

Leap Therapeutics Announces Enrollment Completion in Phase 2 DeFianCe Study and FL-501 Development

6 months ago

• Leap Therapeutics completed enrollment in Part B of the Phase 2 DeFianCe study, evaluating DKN-01 with bevacizumab and chemotherapy for second-line advanced colorectal cancer, with data expected mid-2025. • Patient follow-up is ongoing in Part C of the Phase 2 DisTinGuish study, assessing DKN-01 with tislelizumab and chemotherapy in first-line GEJ and gastric cancer, with data anticipated late 2024 or early 2025. • Leap Therapeutics is advancing FL-501, a monoclonal antibody targeting GDF-15, into development based on promising preclinical data for treating cachexia and other GDF-15-driven diseases. • The company's cash position is expected to fund operations into Q2 2026, supporting continued clinical development and pipeline expansion.

DKN-01 Plus Tislelizumab and Chemotherapy Shows Promise in Advanced Gastric Cancer

7 months ago

• A phase IIa trial of DKN-01 with tislelizumab and chemotherapy demonstrated a 73% objective response rate in advanced gastric or gastroesophageal junction adenocarcinoma. • Median progression-free survival was 11.3 months, and median overall survival reached 19.5 months in patients treated with the DKN-01 combination therapy. • The combination showed activity regardless of PD-L1 expression, suggesting a potential benefit for a broad range of patients with advanced gastric cancer. • Grade 3 or higher adverse events occurred in 60% of patients, with diarrhea, hypokalemia, and decreased hemoglobin being the most common.

FDA Approves Astellas' Vyloy (Zolbetuximab) for Advanced Gastric and GEJ Adenocarcinoma

8 months ago

• The FDA has approved zolbetuximab (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma. • Approval was based on SPOTLIGHT and GLOW trials, demonstrating statistically significant improvements in progression-free and overall survival compared to chemotherapy alone. • The VENTANA CLDN18 (43-14A) RxDx Assay from Roche was also approved as a companion diagnostic to identify patients eligible for Vyloy treatment. • Vyloy is now approved in five markets worldwide, offering a new targeted therapy option for a subset of gastric and GEJ cancer patients.