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Clinical Trial News

Qu Biologics Completes Enrollment in Phase 2 Trial Testing Novel Immunomodulator for Age-Related Immune Decline

  • Qu Biologics has completed enrollment of 72 participants in the RESILIENCE Study, a randomized placebo-controlled Phase 2 trial evaluating QBKPN SSI in adults 65 years and older.
  • QBKPN SSI represents a first-in-class Site Specific Immunomodulator designed to restore innate immune function that naturally declines with aging.
  • The study addresses what the company calls "the largest unmet need in healthcare" by targeting age-related immune decline that increases risks of infections, inflammatory diseases, and cancer.
  • Previous proof-of-concept studies demonstrated QBKPN's ability to reverse immune dysregulation associated with aging, inflammatory diseases, and cancer.

Viatris Wins Patent Battle Against Novo Nordisk Over Generic Wegovy

FDA Approval
  • A federal district court in Delaware ruled that Viatris' generic version of Wegovy does not infringe on Novo Nordisk's patent for the GLP-1 receptor agonist semaglutide.
  • The court determined that Viatris' product label does not encourage use without other therapeutic agents, which was a key limitation in Novo Nordisk's patent claim.
  • This victory removes one patent obstacle for Viatris' generic Wegovy, which is currently awaiting FDA approval, while the global Wegovy market reached $8.4 billion in 2024.
  • The ruling comes amid ongoing patent disputes in the lucrative obesity drug market, with GlobalData forecasting the obesity market to exceed $173.5 billion by 2031.

Federal Court Dismisses Whistleblower Patent Fraud Lawsuit Against Valeant and Salix Over Ulcerative Colitis Drug Apriso

  • A federal judge dismissed a seven-year False Claims Act lawsuit against Valeant Pharmaceuticals and Salix Pharmaceuticals alleging fraudulent patent practices for ulcerative colitis drug Apriso.
  • Whistleblower Zachary Silbersher claimed the companies fraudulently obtained patents, excluded generic competitors, and overbilled Medicare for prescriptions.
  • The dismissal was without prejudice, allowing the plaintiff to amend and refile claims with more specific allegations against each defendant.

Autoantibodies Emerge as Key Predictors of Cancer Immunotherapy Response, Boosting Effectiveness Up to 10-Fold

  • A groundbreaking study published in Nature reveals that naturally occurring autoantibodies can dramatically influence cancer immunotherapy effectiveness, with some boosting patient response rates by five to ten-fold.
  • Researchers analyzed over 6,000 types of autoantibodies in 374 cancer patients receiving checkpoint inhibitors using the novel REAP technology platform.
  • Autoantibodies targeting interferons were linked to better anti-tumor responses, while others hindered treatment effectiveness, offering new targets for combination therapies.
  • The findings provide crucial insights into why checkpoint inhibitors work for some patients but not others, potentially extending benefits to more cancer patients.

FDA Clears Advanced UroNav System for Precision Focal Therapy in Prostate Cancer

  • The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System, featuring advanced annotation workflow for enhanced precision in minimally invasive prostate cancer focal therapy procedures.
  • The platform integrates pre-procedural MRI imaging with real-time intra-procedural ultrasound to provide clinicians with comprehensive visualization of target areas during treatment.
  • The system works in tandem with DynaCAD Urology to support focal therapy planning, delivery, and review, allowing urologists to edit prostate segmentation and add targets as needed.
  • Clinical experts highlight the platform's potential to personalize therapy with greater accuracy while sparing patients unnecessary side effects of traditional treatments.

Stem Cell Therapy Shows Promise for Fertility Restoration in Women with Ovarian Failure

  • A retrospective study of 145 women found that Stem Cell Regenera treatment achieved oocyte activation in nearly 70% of participants with ovarian failure conditions.
  • The therapy resulted in spontaneous pregnancy in 7% of participants and pregnancy through IVF in 14% of treated women.
  • The treatment protocol successfully mobilized CD34+ stem cells in all participants without severe adverse effects, with most experiencing only mild symptoms.
  • Results suggest the combination of G-CSF stem cell mobilization and platelet-rich plasma injection may offer new hope for women with diminished ovarian reserve, poor ovarian response, or premature ovarian insufficiency.

UC Davis Researchers Develop Gene Therapy to Reactivate Silent Genes in Rett Syndrome

Rare Disease
  • UC Davis Health scientists led by Sanchita Bhatnagar have developed a novel gene therapy that reactivates silenced healthy genes in Rett syndrome by targeting microRNA-106a.
  • The therapy uses a DNA-based "sponge" molecule delivered via gene therapy vector to block miR-106a, allowing dormant healthy MECP2 genes to become active again.
  • In female mouse models of Rett syndrome, treated animals showed longer survival, improved movement and cognition, and significant improvements in breathing irregularities.
  • The approach could potentially treat other X-linked genetic conditions and represents a promising therapeutic strategy for a disorder that currently has no cure.

Legacy Healthcare's Cinainu Shows Sustained Hair Regrowth in Pediatric Alopecia Areata Phase 2/3 Trial

  • Legacy Healthcare's topical botanical drug Cinainu demonstrated significant efficacy in treating moderate to severe alopecia areata in children and adolescents, with 47.6% of patients achieving substantial hair regrowth by week 48.
  • The RAAINBOW Phase 2/3 trial showed Cinainu's benefits persisted even after treatment discontinuation, with no immunosuppression-related adverse events reported in the treatment group.
  • Results published in the British Journal of Dermatology represent the first successful treatment for pediatric alopecia areata that maintains efficacy without triggering disease relapse upon discontinuation.

Flatiron Health Triples Global Oncology Research Network, Expanding Real-World Data Access Across Three Countries

AIPrecision Medicine
  • Flatiron Health's international oncology research network has tripled in size over the past year, now encompassing more than 30 partnerships across the UK, Germany, and Japan.
  • The expansion brings Flatiron's total patient database above 5 million records, with new partnerships including major academic medical centers and national cancer centers in each country.
  • The company established Flatiron FORUM, a global consortium addressing data transportability challenges to support multinational cancer research and regulatory decisions.
  • Seven research studies using multinational real-world data have been completed within the past two years, demonstrating the platform's capability for cross-country cohort analyses.

UCSF Chemists Overcome Solubility Issues in Next-Generation Malaria Drug Through Molecular Redesign

  • UCSF researchers successfully modified the molecular structure of artefenomel, a promising malaria drug that failed clinical trials due to poor solubility, by reducing its symmetry to improve dissolution properties.
  • The redesigned compound maintains equal potency against malaria parasites while showing superior effectiveness against artemisinin-resistant strains compared to current standard treatments.
  • This breakthrough addresses a critical need as artemisinin resistance spreads from Southeast Asia to Africa, where 95% of malaria cases and deaths occur among the 600,000 annual fatalities.
  • The optimized molecule can be easily formulated into pills and combined with other anti-malarial drugs, potentially enabling single-dose treatment regimens.

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