Clinical Trial News
SK Bioscience Wins Patent Dispute Against Pfizer Over Pneumococcal Vaccine Components
• South Korea's Supreme Court ruled that SK bioscience's PCV13 components do not infringe on Pfizer's patent claims, allowing the company to export vaccine components to high-demand markets.
• Despite the victory, SK bioscience remains restricted from selling its domestically developed SKYPneumo vaccine in South Korea until 2027 due to a separate patent dispute with Pfizer.
• SK bioscience is simultaneously developing a more advanced 21-valent pneumococcal conjugate vaccine in collaboration with Sanofi, which entered global Phase 3 clinical trials in late 2024.
Tubulis and Bristol Myers Squibb Advance First Collaborative Tubutecan ADC into Clinical Trials
• Tubulis announced that the first antibody-drug conjugate from its strategic partnership with Bristol Myers Squibb has entered clinical development, marking a significant milestone in their 2023 collaboration agreement.
• The ADC candidate leverages Tubulis' proprietary Tubutecan technology, which combines their P5 conjugation system with an exatecan payload to create stable, targeted cancer therapeutics with minimized systemic toxicity.
• This represents the third Tubutecan-based ADC to reach clinical trials within 12 months, following Tubulis' wholly owned programs TUB-030 and TUB-040, demonstrating the platform's versatility for treating solid tumors.
Accropeutics' Oral TYK2/JAK1 Inhibitor Shows Strong Efficacy in Phase 2 Psoriasis Trial
• AC-201, an oral selective TYK2/JAK1 inhibitor, met its primary endpoint with up to 74.3% of patients achieving PASI-75 responses at week 12 across all three dosing regimens tested.
• The drug demonstrated a favorable safety profile with no serious adverse events or discontinuations, positioning it as a potentially competitive option in the growing market for oral psoriasis treatments.
• Based on these positive Phase 2 results, Accropeutics plans to advance AC-201 into Phase 3 development for plaque psoriasis, with potential applications in other autoimmune conditions.
Codex Labs' Shaant ClearSkin Probiotic Receives US Patent for Acne Treatment
• Codex Labs has been granted US Patent No. 12,194,068 for its Shaant ClearSkin Probiotic, a synbiotic supplement designed to address acne through the gut-brain-skin-microbiome axis.
• Clinical trials demonstrated significant improvements in acne patients, with 58.2% reduction in inflammatory lesions, 49.2% decrease in non-inflammatory lesions, and 51% increase in gut butyric acid production after 8 weeks.
• The proprietary formulation combines three core and six supporting probiotic strains with bioactive botanicals including guggul, green tea extract, and riboflavin to target systemic contributors to acne.
NHS England Launches World-First Gonorrhoea Vaccine Amid Record Infection Rates
• England becomes the first country globally to implement a gonorrhoea vaccination program, targeting high-risk populations as infections reach record levels with over 85,000 cases reported in 2023.
• The vaccine, repurposed from the meningitis B jab, offers 30-40% protection against gonorrhoea and will primarily be available to gay and bisexual men with multiple partners or previous STI history.
• Public health officials hope the vaccination program will help combat the rising threat of antibiotic-resistant gonorrhoea strains, potentially preventing 100,000 cases and saving the NHS nearly £8 million over the next decade.
Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize
• Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.
• The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs.
• Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.
Belimumab Shows Superior Efficacy for Systemic Lupus Erythematosus in Meta-Analysis
• A comprehensive meta-analysis of five randomized controlled trials confirms belimumab's superior efficacy over placebo in treating systemic lupus erythematosus (SLE) according to BICLA criteria.
• Patients receiving belimumab demonstrated significantly higher response rates regardless of baseline glucocorticoid dose, with particularly strong results in those with high disease activity or serologically active disease.
• The findings validate belimumab's clinical efficacy through an additional widely used responder index, supporting its use in SLE management according to current recommendations.
Moderna Opposes Arbutus's Request to Reconsider Patent Case Limitations in COVID-19 Vaccine Dispute
• Moderna has filed an opposition in Delaware federal court against Arbutus Biopharma's request to reconsider limitations on patents in their ongoing royalty dispute over COVID-19 vaccine technology.
• The pharmaceutical giant accused Arbutus and co-plaintiff Genevant Sciences of making inconsistent factual representations to avoid case limitations, calling their approach "unabashedly inconsistent" and "opportunistic."
• This legal battle centers on Arbutus's claim for royalties from Moderna's COVID-19 vaccine, highlighting the complex intellectual property disputes surrounding pandemic vaccine development.
AbbVie Sues Hetero Labs Over New Orilissa Patent to Block Generic Endometriosis Drug
• AbbVie has filed a new patent infringement lawsuit against Hetero Labs to prevent the production of generic versions of its endometriosis drug Orilissa (elagolix sodium).
• The lawsuit centers on US Patent No. 12,102,637, which was recently issued on October 1 and is licensed from Neurocrine Biosciences with protection extending for another 13 years.
• This legal action represents AbbVie's expanded effort to block all potential generic competitors, with Hetero Labs being described as the "last holdout" in the company's patent protection strategy.
Novel IL-2 Derivative Shows Complete Remission in Advanced Skin Cancer Patient After One Year
• A 73-year-old patient with advanced cutaneous squamous cell carcinoma has remained cancer-free for over a year following treatment with WTX-124, a novel conditionally activated IL-2 pro-drug, in a clinical trial at HonorHealth Research Institute.
• The investigational drug is engineered to remain inactive until it reaches the tumor microenvironment, potentially delivering the benefits of IL-2 therapy with significantly reduced toxicity compared to conventional treatments.
• This breakthrough offers new hope for the nearly 40,000 U.S. patients annually who develop advanced cutaneous squamous cell carcinoma, particularly those who have failed standard treatments including checkpoint inhibitor therapy.