The FDA fast-tracked an inhalable gene therapy for advanced lung cancer after an early 11-patient trial showed tumour shrinkage in three patients and disease stabilization in five. Larger studies involving about 250 patients are underway.
Scientists are testing experimental cancer therapies including mRNA therapeutic vaccines, engineered EcN bacteria that deliver romidepsin in mice, and macrophage-targeted CAR T cells.
PDS Biotechnology will report 2025 financial results and provide clinical updates on March 30, 2026. The company faces critical regulatory decisions for its Phase 3 VERSATILE-003 trial in HPV16-positive head and neck cancer and is expanding its immunotherapy platform to prostate cancer and other solid tumors.
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
Ankyra Therapeutics announced preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137, showing strong anti-tumor activity with no observed systemic toxicity at the AACR Immuno-Oncology Conference.