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- Orchestra BioMed received FDA approval for a protocol update that expands patient eligibility for the BACKBEAT pivotal study by more than 24-fold compared to the original protocol. - The expanded criteria now include any hypertensive patients with Medtronic Azure or Astra pacemakers, including device replacements and those with NYHA class I or II heart failure. - The company targets mid-2026 for completion of enrollment in the study evaluating AVIM therapy for uncontrolled hypertension in pacemaker patients. - AVIM therapy previously demonstrated net reductions of 8.1 mmHg in ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure in the MODERATO II pilot study.
- A phase 1 clinical trial of DOC1021 (dubondencel), an individualized dendritic cell therapy, demonstrated positive immune responses and improved survival in 16 newly diagnosed glioblastoma patients. - The treatment creates a personalized vaccine from each patient's tumor tissue to train the immune system to attack cancer cells, including those that evade surgical removal. - Researchers observed tumor disappearance on MRIs in some patients, an unprecedented outcome for glioblastoma where survival rates have remained unchanged for 20 years. - Diakonos Oncology has initiated a phase 2 trial of DOC1021 at 20 sites nationwide following the encouraging safety and efficacy results.
