NATIONAL TAIWAN UNIVERSITY HOSPITAL

3D Pathology Technology Reclassifies 67% of HER2-Null Breast Cancer Cases as HER2-Expressing

a month ago

• JelloX Biotech's 3D pathology technology identified significantly more HER2-low and HER2-ultralow breast tumors compared to conventional diagnostic methods in a study with National Taiwan University Hospital. • Over 50% of analyzed breast cancer cases showed diagnostic discrepancies when re-evaluated with 3D pathology, with 66.7% of initially HER2-null patients reclassified as HER2-expressing. • The improved detection sensitivity could expand treatment eligibility for Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate that has shown robust efficacy in HER2-low and HER2-ultralow metastatic breast cancer.

Volition's Nu.Q® Cancer Test Shows Promise in Lung Cancer Screening and Pan-Cancer Detection

2 months ago

• Volition has enrolled the first patient in a 500-patient validation study at National Taiwan University Hospital to evaluate Nu.Q® Cancer technology for distinguishing between malignant and benign pulmonary nodules in LDCT lung cancer screening. • A recently published study demonstrated that Nu.Q® Cancer test can accurately detect 21 different cancer types with high specificity, positioning it as a potential standalone pan-cancer test or complement to existing liquid biopsy technologies. • The company is pursuing multiple licensing agreements with diagnostic and liquid biopsy companies in 2025, targeting the $20 billion liquid biopsy market with a test that can run on existing automated platforms worldwide.

National Taiwan University Hospital and AbbVie Biopharma Enhance Digital Strategies for Clinical Trials

4 months ago

National Taiwan University Hospital (NTUH) and AbbVie Biopharmaceuticals GmbH Taiwan Branch have signed a cooperation agreement to strengthen digital strategies for clinical trials, aiming to accelerate trial approvals and improve quality. This collaboration builds on a decade-long partnership that has seen significant milestones in clinical trial research.

FDA Grants Priority Review to Sunvozertinib for NSCLC with EGFR Exon 20 Insertions

5 months ago

• The FDA granted priority review to sunvozertinib for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. • The application is for patients whose disease progressed after platinum-based chemotherapy, offering a potential new oral treatment option. • The decision is based on the WU-KONG1 Part B study, which showed statistically significant clinical benefits in relapsed/refractory NSCLC. • Sunvozertinib has already received accelerated approval in China for the same indication, marking it as a promising treatment worldwide.

Barinthus Bio's VTP-300 Shows Promise in Phase IIb Trial for Chronic Hepatitis B

6 months ago

• Barinthus Bio's Phase IIb HBV003 trial shows that VTP-300, combined with low-dose nivolumab, leads to HBsAg loss in chronic hepatitis B patients. • Eight patients experienced complete HBsAg loss, with two achieving functional cure, defined as sustained HBsAg loss and undetectable HBV DNA off-treatment for six months. • Preliminary safety data indicates that the combination of VTP-300 and low-dose nivolumab is generally well-tolerated, with no treatment-related serious adverse events reported. • The study suggests that VTP-300 may help patients discontinue antiviral treatment without disease progression, offering a potential step towards a functional cure for chronic hepatitis B.

Combination Therapies Show Promise for Functional Cure of Chronic Hepatitis B

6 months ago

• A Phase II trial of xalnesiran plus immunomodulators showed significant hepatitis B surface antigen (HBsAg) loss in patients with chronic HBV infection. • VTP-300 combined with low-dose nivolumab demonstrated sustained HBsAg reductions, meeting functional cure criteria in a Phase 2b trial. • Both studies highlight the potential for novel combination therapies to achieve functional cures and allow patients to discontinue lifelong antiviral treatment. • Further research is needed to address challenges in durability of response and efficacy in patients with high HBsAg levels.

FDA Approves First Gene Therapy Directly Administered to the Brain for AADC Deficiency

6 months ago

• The FDA granted accelerated approval to KEBILIDI™, a gene therapy for AADC deficiency, marking the first such therapy directly administered to the brain. • KEBILIDI™ delivers a healthy copy of the DDC gene via a modified virus, restoring dopamine production in patients with AADC deficiency. • Clinical trials demonstrated significant improvements in motor function and development in treated children, including the youngest patient who experienced remarkable progress. • Early diagnosis and treatment are crucial for maximizing the benefits of KEBILIDI™, with potential for newborn screening to identify affected infants.

Barinthus Bio's VTP-300 Shows Promise in Achieving Functional Cure for Chronic Hepatitis B

6 months ago

• Barinthus Bio announced Phase 2b HBV003 trial results showing HBsAg loss in eight participants treated with VTP-300 and low-dose nivolumab. • Two participants met the criteria for functional cure, demonstrating the potential of VTP-300 in chronic hepatitis B treatment. • Two participants achieved HBsAb seroconversion after discontinuing NUC therapy, indicating a possible immune response shift. • The HBV003 trial is evaluating VTP-300 with nivolumab in 121 participants, including those with low HBsAg levels.

VANCE Trial: Largest T Cell Therapy Study in Solid Tumors Shows Promise for Precision Immunotherapy in Nasopharyngeal Carcinoma

6 months ago

• The VANCE trial, the largest T cell therapy study for solid tumors, demonstrates Singapore's expertise in global cell therapy trials, marking a significant milestone in precision immunotherapy. • The Phase III trial evaluated EBV-CTL therapy combined with chemotherapy for nasopharyngeal carcinoma (NPC), showing safety but no overall survival improvement in the entire cohort. • Subset analysis revealed improved progression-free and overall survival in US, Singapore, and Taiwan sites, suggesting potential for refining T cell therapy approaches using biomarkers. • Future research will focus on identifying biomarkers to optimize T cell therapy development and administration, potentially enhancing treatment outcomes for patients with NPC.

VANCE Trial: T Cell Therapy Shows Promise in Subset of Nasopharyngeal Cancer Patients

6 months ago

• The VANCE trial, the largest T cell therapy study for solid tumors, evaluated EBV-CTL therapy in advanced nasopharyngeal carcinoma (NPC). • While the overall trial did not meet its primary endpoint, a subset analysis showed improved progression-free and overall survival in US, Singapore, and Taiwan sites. • The study highlights the need for biomarker identification to optimize patient selection and T cell therapy design for enhanced efficacy. • This trial demonstrates Singapore's capability in executing complex, large-scale cell therapy trials, paving the way for precision immunotherapy.

VANCE Trial: T Cell Therapy Shows Promise in Subgroup of Solid Tumor Patients

6 months ago

• The VANCE trial, the largest T cell therapy trial for solid tumors, demonstrated the feasibility of large-scale T cell production and delivery. • While the overall trial did not show a survival benefit, a subset analysis revealed improved progression-free and overall survival in patients treated with EBV-CTL therapy plus chemotherapy. • Researchers are now focused on identifying biomarkers to refine patient selection and optimize T cell therapy design for enhanced outcomes. • The study underscores the potential of personalized T cell therapies and the need for further research to improve efficacy in solid tumors.

Sacituzumab Govitecan Demonstrates Efficacy in HR+/HER2- Metastatic Breast Cancer

8 months ago

• Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) compared to chemotherapy in patients with HR+/HER2- metastatic breast cancer. • The phase 3 EVER-132-002 trial included patients who had received two to four prior chemotherapy regimens, showing SG's benefit in heavily pre-treated populations. • SG demonstrated a manageable safety profile, supporting its potential as a valuable treatment option for this patient population in regions including mainland China, Republic of Korea and Taiwan. • The study's findings contribute to addressing the unmet need for effective therapies in HR+/HER2- metastatic breast cancer, particularly after multiple lines of treatment.

Oneness Biotech's SNS812 Demonstrates Superior Efficacy Against COVID-19 Variants in Phase 2 Trial

8 months ago

• Oneness Biotech and Microbio (Shanghai)'s SNS812 achieved statistically significant and clinically meaningful endpoints in a Phase 2 trial for COVID-19 treatment. • SNS812 demonstrated efficacy against prevalent COVID-19 variants, including JN.1, KP1-4, LB.1, BA.2, and XBB, with a good safety profile and no drug-related adverse events. • The trial showed SNS812 significantly reduced the time to viral negativity (median 2.9 days in the 200mg group) and improved symptoms like loss of smell and taste compared to placebo. • SNS812 presents a potential breakthrough solution for treating COVID-19, addressing the urgent need for therapies effective against emerging variants.