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Clinical Trial News

Nautilus Biotechnology Partners with Allen Institute to Advance Alzheimer's Research Through Single-Molecule Proteomics

  • Nautilus Biotechnology has entered into an agreement with the Allen Institute to investigate the connection between tau protein and Alzheimer's disease using single-molecule proteomics technology.
  • The collaboration will employ Nautilus' Iterative Mapping method to identify novel tau proteoforms from human brain tissue and characterize phosphorylation patterns that may predict disease progression.
  • Nautilus' recent preprint demonstrates the platform's ability to analyze millions to billions of single-protein molecules with unprecedented resolution, providing actionable biological insights from brain samples of cognitively normal and impaired Alzheimer's patients.

Ionis Pharmaceuticals Reports Strong Q2 2025 Results, Raises Guidance on TRYNGOLZA Success

Drug ApprovalRare Disease
  • Ionis Pharmaceuticals delivered $19 million in net product sales for TRYNGOLZA in Q2 2025, driving a doubling of total revenue to $452 million compared to the same period last year.
  • The company raised its 2025 financial guidance for the second time this year, increasing total revenue expectations to $825-850 million from the previous $725-750 million range.
  • Donidalorsen for hereditary angioedema is on track for U.S. approval with a PDUFA date of August 21, 2025, representing Ionis' second independent product launch.
  • Phase 3 data from pivotal CORE and CORE2 studies for olezarsen in severe hypertriglyceridemia are expected in September 2025, potentially expanding the drug's market opportunity.

Cardiosense Receives FDA Clearance for CardioTag, First Wearable to Monitor Heart Rhythm and Mechanical Function

AI
  • Cardiosense announced FDA 510(k) clearance for CardioTag, the first wearable device to simultaneously collect ECG, PPG, and seismocardiogram signals for comprehensive cardiac monitoring.
  • The device enables clinicians to assess not only heart rhythm but also mechanical and hemodynamic function, providing unprecedented visibility into cardiac performance across care settings.
  • A recent multicenter study showed Cardiosense's AI algorithm for pulmonary capillary wedge pressure estimation achieved accuracy comparable to implantable hemodynamic sensors in heart failure patients.
  • The clearance represents a significant advancement in noninvasive cardiac monitoring, moving beyond traditional ECG-focused approaches to include cardiac mechanics and blood flow assessment.

FDA Grants Orphan Drug Designation to VT3989 for Mesothelioma Treatment

  • The FDA has granted orphan drug designation to VT3989, a first-in-class TEAD autopalmitoylation inhibitor developed by Vivace Therapeutics for treating mesothelioma.
  • VT3989 targets the Hippo pathway by blocking palmitoylation of TEAD proteins, which control cell growth and division processes that can lead to cancer when disrupted.
  • The drug has shown encouraging clinical activity and favorable safety profile in an ongoing Phase 1 study of over 200 patients, particularly in mesothelioma patients who failed chemotherapy and immunotherapy.
  • Vivace Therapeutics plans to discuss moving into a registrational Phase 3 study in mesothelioma with the FDA by the end of 2025.

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

NCT04665206RecruitingPhase 1
Vivace Therapeutics, Inc
Posted 3/24/2021

BioDuro and Atombeat Launch AI-Powered Platform to Accelerate Peptide Drug Discovery

AI
  • BioDuro and Atombeat have announced a strategic partnership to develop an AI-driven platform that accelerates peptide drug discovery from molecular design to preclinical candidates.
  • The collaboration combines Atombeat's AI modeling technologies, capable of exploring over one trillion peptide compounds in silico, with BioDuro's expertise in peptide chemistry and high-throughput synthesis.
  • The integrated platform enables rapid screening of peptide candidates based on key traits like membrane permeability before lab testing, followed by BioDuro's ability to produce hundreds of high-purity peptides within one week.
  • This end-to-end workflow aims to deliver faster timelines and better cost-effectiveness for developing next-generation peptide therapeutics across broad therapeutic areas.

Prisma Health and Siemens Healthineers Expand $50M Partnership to Advance AI-Driven Cancer Care

  • Prisma Health and Siemens Healthineers are expanding their 10-year Value Partnership with a $50 million investment in advanced radiation therapy technology, including the Ethos adaptive radiotherapy system.
  • The partnership integrates AI-driven treatment planning that adapts to tumor and anatomical changes in real time, providing more precise and personalized cancer care while protecting healthy tissue.
  • The collaboration aims to establish a full continuum of cancer care from screening through survivorship, combining diagnostic imaging, radiation therapy, and post-treatment monitoring with specialized clinical services.
  • The expanded partnership builds on their existing 2021 agreement and focuses on improving care accessibility, promoting innovation, and developing the local healthcare workforce in South Carolina and Tennessee.

DX&VX Secures $220 Million mRNA Cancer Vaccine Licensing Deal with U.S. Biotech Partner

Oncology
  • DX&VX has signed its first global out-licensing agreement worth approximately $220 million with a U.S. biotech company for its proprietary mRNA-based cancer vaccine technology.
  • The agreement includes development milestones totaling $220 million plus sales-based milestone payments exceeding 10% of cumulative sales over 15+ years, with projected post-commercialization revenues potentially exceeding $940 million.
  • DX&VX will retain responsibility for leading R&D activities including preclinical studies and Phase 1-3 clinical trials, while the partner handles global regulatory approvals and commercialization.
  • The licensed mRNA cancer vaccine has demonstrated superior anticancer efficacy in preclinical animal studies compared to global competitors currently in Phase 2b trials.

BriaCell Secures New Zealand Patent for HLA-Matched Whole-Cell Cancer Immunotherapy Technology

Precision Medicine
  • BriaCell Therapeutics has been granted New Zealand Patent No. 785587 for its whole-cell cancer vaccine technology, providing exclusivity through February 27, 2037.
  • The patent covers methods for selecting whole-cell cancer immunotherapy based on HLA allele profile matching to personalize treatment for cancer patients.
  • This patent award supports BriaCell's precision medicine approach and is part of the company's broader strategy to establish a strong international patent portfolio.
  • The technology aims to transform cancer care by personalizing immunotherapy for improved patient outcomes across multiple cancer indications.

Anika's Hyalofast Cartilage Repair Treatment Shows Mixed Results in Phase III Trial

  • Anika Therapeutics' Hyalofast cartilage repair scaffold failed to meet its co-primary endpoints in the pivotal FastTRACK Phase III study, missing statistical significance for KOOS Pain and IKDC function improvements over microfracture.
  • The treatment demonstrated statistically significant improvements in key secondary endpoints including KOOS Sports and Recreation Function and Quality of Life, measures that have supported prior FDA approvals for cartilage repair products.
  • Despite the mixed results, Anika plans to file the final PMA module in the second half of 2025, leveraging data from over 35,000 patients treated globally since 2009.
  • The study was impacted by higher dropout rates in the control arm and COVID-related missed visits, which reduced the evaluable sample size and complicated statistical analysis.

Viridian Therapeutics Secures $385 Million Deal with Kissei for Thyroid Eye Disease Therapies in Japan

Monoclonal AntibodyRare Disease
  • Viridian Therapeutics has entered into an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan, receiving $70 million upfront with potential milestone payments up to $315 million.
  • Both drug candidates are anti-IGF-1R antibodies targeting thyroid eye disease, with veligrotug having demonstrated positive results in phase 3 THRIVE trials and VRDN-003 being a subcutaneous, half-life extended formulation.
  • The collaboration leverages Kissei's expertise in rare disease development and commercialization in Japan to address significant unmet medical needs for TED patients.
  • Viridian will also receive tiered royalties ranging from the 20s to mid-30s percent on net sales in Japan, while Kissei assumes all development and commercialization responsibilities.

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