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Clinical Trial News

Cellex Expands GMP Manufacturing Capacity Following Production of Over 5,800 Cell and Gene Therapy Batches

CAR-T
  • Cellex Cell Professionals announces major facility expansion, now operating over 2,500 m² of GMP-certified manufacturing area with 43% allocated to cleanroom operations across 37 workstations.
  • The German CDMO has manufactured more than 5,800 CGT/ATMP batches including 1,300+ clinical and 4,500+ commercial products, supporting three EU-approved CAR-T therapies.
  • In 2023, Cellex successfully manufactured Europe's first allogeneic CAR-T product, demonstrating its capabilities in cutting-edge cellular therapy development.
  • The company onboarded two new clients in January 2025 with a robust pipeline of new mandates planned for the remainder of the year.

CN Bio Expands FDA-Recognized DILI Assay with Cross-Species Models to Improve Drug Safety Predictions

  • CN Bio has introduced two new animal microphysiological system models that extend their FDA-recognized drug induced liver injury assay to include rat and dog models alongside human models for comparative safety studies.
  • The expanded PhysioMimix DILI assay enables rapid comparative studies between animal and human liver-on-a-chip models to identify interspecies differences early in preclinical development and reduce costly late-stage failures.
  • The new cross-species platform addresses critical gaps in drug safety prediction by providing 14-day longitudinal testing capabilities that can flag hepatotoxicity risks before in vivo studies, potentially reducing animal testing requirements.

Emulate Launches High-Throughput AVA System to Replace Animal Testing in Drug Development

  • Emulate has commercially launched the AVA Emulation System, a self-contained instrument that processes up to 96 independent Organ-Chip samples simultaneously while delivering in vivo-level insights faster than animal models.
  • The system reduces consumable costs by four-fold and cuts in-lab labor by half compared to previous generation technologies, while generating over 30,000 time-stamped data points per seven-day experiment.
  • AVA addresses FDA's push to make animal studies "the exception rather than the norm," building on Emulate's Liver-Chip S1 which demonstrated 87% sensitivity and 100% specificity for drug-induced liver injury.
  • The platform enables pharmaceutical companies to screen compounds at microplate-level scale with human-relevant biology, with one company already saving millions of dollars and years of development time using Emulate's technology.

WuXi Biologics Partners with Virogen to Advance First-in-Class Anti-CD3 Immunotoxin VG712 Toward Commercial Manufacturing

  • WuXi Biologics has established a strategic manufacturing partnership with Virogen Biotechnology to provide comprehensive services for VG712, a first-in-class anti-CD3 immunotoxin designed for immunological reset therapy.
  • VG712 targets T cell dysregulation underlying cancers and autoimmune diseases by rapidly depleting existing T cells to allow immune system regeneration, with FDA Fast Track designation and ongoing Phase II trials.
  • The collaboration leverages WuXi Biologics' microbial fermentation platform and new Chengdu facility to enable VG712's transition from late-stage development to commercial production, targeting BLA submission between 2027-2028.
  • The partnership demonstrates WuXi Biologics' expanding capabilities in complex molecule manufacturing while positioning Virogen for global market launch of their transformative immunotherapy approach.

Inflation Reduction Act to Lower BTK Inhibitor Costs, Potentially Transforming CLL and MCL Treatment Access

  • The Inflation Reduction Act will introduce price negotiations and cap out-of-pocket costs for BTK inhibitors like ibrutinib starting in 2026, potentially improving treatment affordability for CLL and MCL patients.
  • Current financial barriers force many patients to maintain inconsistent dosing due to cost constraints, which may compromise treatment efficacy and contribute to resistance development.
  • Lower costs could encourage healthcare systems to prioritize targeted BTK inhibitor therapies over older chemotherapy regimens, particularly benefiting underserved communities and reducing treatment disparities.
  • The policy changes may create broader pricing pressure across second- and third-generation BTK inhibitors, potentially transforming accessibility of oral oncology drugs nationwide.

Novoviah's NovoleukinTM Platform Achieves 90% Sensitivity in Celiac Disease Detection Through Novel T Cell Testing

  • Novoviah Pharmaceuticals' NovoleukinTM test platform demonstrated 90% sensitivity and 95% specificity in detecting celiac disease through T cell reactivity measurement in a study of 181 volunteers.
  • The blood-based diagnostic can detect as few as one gluten-specific T lymphocyte per milliliter of blood, eliminating the need for patients to return to gluten consumption for diagnosis.
  • The platform successfully identifies celiac disease even in patients following strict gluten-free diets, addressing a major limitation of traditional diagnostic methods.
  • Results published in Gastroenterology show the test's potential for broader clinical applications in immunotherapy development and monitoring treatment efficacy across multiple immune-mediated diseases.

USPTO Denies iRhythm Patent Challenges for Vital Signs Monitoring Technology

  • The US Patent and Trademark Office denied iRhythm Technologies' challenges to four patents covering medical technology for vital signs monitoring, with inventions dating back to 2012.
  • Acting Director Coke Morgan Stewart cited "settled expectations" as the key factor against reviewing patent validity, despite acknowledging several arguments favored iRhythm's position.
  • iRhythm was aware of one patent as early as 2013 and cited the pending application in its own patent filing, but failed to seek review earlier.
  • The decision highlights the importance of timing in patent challenges and the USPTO's consideration of established industry expectations in patent disputes.

EZZ Life Science Secures $21M Distribution Agreement for Genomic Wellness Products in Southeast Asia

  • EZZ Life Science Holdings has signed a three-year, $21 million minimum distribution agreement with ROFA Enterprises to expand genomic wellness and functional health products across Thailand, Vietnam, and Singapore.
  • The partnership leverages ROFA's established omnichannel distribution network reaching over 10,000 pharmacies, mother-and-baby stores, supermarkets, and online platforms throughout Southeast Asia.
  • EZZ maintains full control over brand integrity and product positioning while ROFA assumes all marketing, distribution, and logistics costs during the agreement period.
  • The deal represents a strategic expansion into one of the fastest-growing regions for consumer health and wellness, driven by rising health consciousness and expanding middle-class populations.

Smartphone App Delivers Breakthrough in Huntington's Disease Clinical Trial Efficiency

  • A new smartphone-based digital motor score (HDDMS) developed by UCL and Roche researchers demonstrates twice the sensitivity of current clinical measures in detecting Huntington's disease progression.
  • The five-minute home-based assessment could reduce clinical trial participant requirements and study durations, potentially accelerating drug development for this devastating neurodegenerative condition.
  • Research involving 1,048 participants across four studies shows the digital biomarker approach offers convenient, reliable monitoring of motor symptoms outside clinical settings.

RenaissThera Advances AI-Designed Oral Obesity Drug Targeting GIPR to Lead Optimization

AIDrug Discovery
  • RenaissThera achieved a major discovery milestone in developing oral small molecule drugs targeting the glucose-dependent insulinotropic polypeptide receptor (GIPR) for obesity treatment.
  • The company's AI and machine learning platforms successfully designed and screened novel GIPR modulators that demonstrated in-vitro and in-vivo activity in mice.
  • These oral small molecules offer a more affordable and convenient alternative to existing peptide-based obesity therapies in a market projected to reach $38 billion by 2032.
  • RenaissThera is now advancing these "hits" to lead optimization and plans to push candidates toward IND-readiness next year.

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