MedPath

Clinical Trial News

Biocytogen and Nanjing Chia Tai Tianqing Receive IND Approval for Second-Generation Anti-IGF-1R Antibody NTB003 in Thyroid Eye Disease

Monoclonal Antibody
  • Biocytogen and Nanjing Chia Tai Tianqing received IND approval from China's NMPA for NTB003, a second-generation fully human anti-IGF-1R monoclonal antibody targeting Thyroid Eye Disease.
  • NTB003 demonstrates enhanced molecular affinity, improved druggability, and extended half-life compared to first-generation anti-IGF-1R therapeutics, with potent signal-blocking activity in vitro studies.
  • Clinical studies of anti-IGF-1R biologics have shown rapid therapeutic response and favorable outcomes in reducing proptosis and diplopia while improving quality of life in TED patients.
  • Nanjing Chia Tai Tianqing will lead clinical development and commercialization in China, while Biocytogen handles global out-licensing outside China.

Oncovita Receives FDA Orphan Drug Designation for Oncolytic Measles Virus Therapy in Pleural Mesothelioma

FDA Approval
  • Oncovita's MVdeltaC, a genetically modified measles virus immunotherapy, has received FDA Orphan Drug Designation for treating pleural mesothelioma, a rare and aggressive cancer affecting approximately 3,000 Americans annually.
  • The novel oncolytic virus combines direct tumor cell destruction with immune system activation, representing a promising approach for patients with limited therapeutic options.
  • The designation provides significant regulatory benefits including tax credits, fee waivers, and up to seven years of market exclusivity, positioning Oncovita to enter clinical development by 2026.

CARBOGEN AMCIS Shanghai Facility Receives First Drug Manufacturing License from China's NMPA

  • CARBOGEN AMCIS Shanghai facility has been awarded its first Drug Manufacturing License by China's National Medical Products Administration following comprehensive GMP compliance inspection.
  • The 40,000 m² facility in Shanghai Chemical Industry Park offers full-service capabilities from early R&D to commercial production with four segregated units and reactor capacities up to 6,300 litres.
  • The license approval marks a strategic milestone in CARBOGEN AMCIS' Asian expansion and strengthens the company's ability to serve pharmaceutical partners throughout the region.
  • The facility employs over 140 staff and is equipped to handle highly potent compounds up to category 3 with comprehensive analytical and GMP release services.

Repertoire Immune Medicines Appoints Oncology Veteran as CMO, Advances TCR Bispecific Toward Phase 1/2 Trial

  • Repertoire Immune Medicines has appointed Robert Andtbacka, MD, as Chief Medical Officer to strengthen leadership as the company prepares for its first clinical trial.
  • The company's lead candidate RPTR-1-201, a TCR bispecific targeting novel peptides on solid tumors, is progressing through IND-enabling studies following positive regulatory interactions.
  • RPTR-1-201 represents Repertoire's first clinical-stage asset discovered using their proprietary DECODE platform, with plans to initiate Phase 1/2 trials across multiple cancer indications.
  • Dr. Andtbacka brings over 20 years of oncology drug development experience from roles at HiFiBiO Therapeutics, Seven and Eight Biopharmaceuticals, and Huntsman Cancer Institute.

Lipella Pharmaceuticals Renews Manufacturing Partnership with Cook MyoSite to Advance Oral Lichen Planus Treatment

  • Lipella Pharmaceuticals has re-signed its manufacturing collaboration agreement with Cook MyoSite to support Chemistry, Manufacturing and Control documentation for clinical products LP-10 and LP-310.
  • LP-310 is a liposomal-tacrolimus oral rinse formulation being developed for oral lichen planus, a condition with no approved treatments currently available.
  • The company reported positive topline results from the second cohort (0.50 mg) of its Phase 2a multicenter, dose-ranging trial evaluating LP-310 in April.
  • This partnership supports late-stage development and scalable manufacturing as Lipella's clinical pipeline matures toward commercializable assets.

USP Opens Advanced Technologies Laboratory to Strengthen Pharmaceutical Supply Chains and Manufacturing

  • The US Pharmacopeia opened its Advanced Technologies Laboratory in Rockville, Maryland on June 4, 2025, expanding its laboratory footprint to over 70,000 square feet across the United States and India.
  • The facility will develop approaches for flow chemistry and advanced analytical techniques to help manufacturers adopt modern production technologies and enable real-time quality monitoring.
  • The laboratory aims to strengthen medicine supply chains through strategic onshoring, distributed manufacturing capabilities, and support for personalized medicine development.
  • USP plans to add an additional 8,000 square feet of laboratory space in 2026 to further expand its advanced manufacturing research capabilities.

Myriad Genetics Launches FirstGene Multiple Prenatal Screen with Four-in-One Testing Capability

  • Myriad Genetics announced early access to the FirstGene Multiple Prenatal Screen, a comprehensive four-in-one genetic test that combines fetal aneuploidy screening, recessive disease screening, carrier screening, and RhD compatibility assessment in a single blood draw.
  • The innovative screening technology eliminates the need for paternal testing by directly identifying fetal genotypes using cell-free DNA from the pregnant person, addressing the current gap where only 41.5% of male partners receive carrier screening.
  • The FirstGene screen achieved impressive analytical performance with more than 98.6% sensitivity and 99.6% specificity across variants, and will be evaluated through the CONNECTOR study enrolling over 5,000 patients from multiple clinical sites.
  • This launch represents a significant advancement in prenatal genetic testing by streamlining multiple screening modalities into one assay, potentially improving access to guideline-driven testing for more patients.

Vadadustat Phase 3 Data Reveals Geographic Differences in CKD Anemia Treatment Outcomes

Drug Approval
  • The Journal of the American Society of Nephrology published pre-specified analyses from vadadustat's global phase 3 program, comparing U.S. and non-U.S. patient outcomes in chronic kidney disease-related anemia treatment.
  • Among dialysis-dependent CKD patients, vadadustat showed similar safety and efficacy to darbepoetin alfa both within and outside the United States.
  • For non-dialysis-dependent CKD patients in the U.S. subgroup, vadadustat demonstrated higher cardiovascular risk compared to darbepoetin alfa when used outside the United States.
  • The analyses highlight how regional differences in patient characteristics, hemoglobin targets, and healthcare practices can influence treatment outcomes in global clinical trials.

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

NCT02892149CompletedPhase 3
Akebia Therapeutics
Posted 8/1/2016

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

NCT02865850CompletedPhase 3
Akebia Therapeutics
Posted 7/1/2016

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT02680574CompletedPhase 3
Akebia Therapeutics
Posted 2/1/2016

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

NCT02648347CompletedPhase 3
Akebia Therapeutics
Posted 12/1/2015

EMA Issues Strategic Recommendations to Address Critical Radiopharmaceutical Supply Chain Vulnerabilities in Europe

  • The European Medicines Agency and Heads of Medicines Agencies have released comprehensive recommendations to tackle vulnerabilities in Europe's radiopharmaceutical supply chain, addressing increasing demand amid limited manufacturing capacity.
  • The global radiopharmaceutical market is projected to grow from $6.97 billion in 2024 to $11.06 billion by 2034, while European production relies heavily on materials sourced from geopolitically sensitive regions including China and Russia.
  • Key recommendations include enhancing domestic production capabilities, developing EU-based HALEU enrichment facilities, and harmonizing transport procedures to ensure reliable supply of these critical cancer diagnostic and treatment medicines.
  • The initiative involves multiple stakeholders including the European Radioisotope Valley Initiative and Strategic Agenda for Medical Applications of Ionising Radiation to strengthen Europe's medical radioisotope infrastructure and reduce dependency on third-country suppliers.

MHRA Issues First UK Guidance for Phage Therapy Development to Combat Antibiotic-Resistant Infections

  • The UK's Medicines and Healthcare products Regulatory Agency published the country's first official guidance for developing phage therapies, treatments using viruses to target harmful bacteria.
  • The guidance addresses both combined phage products for common infections and personalized therapies for patients with rare or highly resistant infections where antibiotics fail.
  • With over 60,000 serious antibiotic-resistant infections annually in the UK, phage therapy represents a promising approach to treat infections when standard antibiotics are ineffective.
  • The 28-page document provides clear regulatory pathways from early research through patient use, helping developers navigate quality, safety, and manufacturing requirements.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.