Clinical Trial News
MSD Expands Opevesostat Clinical Program to Include Breast, Endometrial, and Ovarian Cancers
• MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program.
• Opevesostat, an oral, non-steroidal and selective CYP11A1 inhibitor discovered by Orion, will be tested for safety and efficacy in breast, endometrial, and ovarian cancers.
• The expansion represents a significant broadening of potential therapeutic applications for opevesostat, which is already in Phase 3 trials for metastatic castration-resistant prostate cancer.
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Merck Sharp & Dohme LLC
Posted 7/17/2025
Applied StemCell Launches Hypoimmunogenic hiPSC Products to Advance Allogeneic Cell Therapy Development
• Applied StemCell has introduced two new hypoimmunogenic human induced pluripotent stem cell (hiPSC) products designed to overcome immune rejection challenges in allogeneic cell therapy development.
• The products feature B2M/CIITA double knock-out modifications that eliminate HLA class I and II expression, significantly reducing the risk of T cell-mediated immune rejection in transplanted cells.
• Derived from CD34+ umbilical cord blood cells with low mutational burden, these research-use-only tools are isogenic matches to forthcoming GMP-grade versions, offering researchers a seamless transition from early research to clinical development.
Closed Loop Medicine Appoints Kate Woolland as CEO to Drive Precision Dosing Commercialization
• Closed Loop Medicine has appointed Kate Woolland as CEO to lead the company's transition from product development to commercial deployment of its pharmaceutical precision dosing platform.
• The company has built an extensive IP portfolio with over 60 filings across 16 patent families, covering precision dosing technologies for GLP-1 therapies, hypertension, and other therapeutic areas.
• CLM's proprietary approach has demonstrated improved patient medication adherence rates exceeding 90% through personalized titration, positioning the company to pursue strategic partnerships and licensing opportunities.
Mirai Bio Partners with Thermo Fisher Scientific to Accelerate Genetic Medicine Development
• Mirai Bio and Thermo Fisher Scientific have formed a strategic collaboration combining Mirai's machine intelligence platform with Thermo Fisher's manufacturing capabilities to optimize genetic medicine development.
• The partnership will leverage Thermo Fisher's cGMP services and commercial manufacturing expertise alongside Mirai's technology for designing tissue-targeted delivery vehicles for nucleic acid therapeutics.
• This collaboration includes a direct investment into Mirai Bio as part of Flagship Pioneering's existing partnership with Thermo Fisher, aiming to jointly develop transformative capabilities for the genetic medicine industry.
New Genetic Findings Challenge Traditional Understanding of Coats' Disease
• Research led by Dr. David Abramson reveals that Coats' disease, traditionally considered unilateral, shows bilateral involvement when examined with fluorescein angiography, challenging long-held clinical beliefs.
• Genetic testing identified a variation in the LTBP2 gene associated with Coats' disease, providing new insights into the condition's genetic underpinnings and supporting the concept that single genes can influence multiple diseases.
• Treatment approaches combining laser photocoagulation and anti-VEGF therapy showed promising results in advanced cases, though researchers speculate effectiveness may be linked to specific telomere biology disorders.
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.