VCN-01

Theriva Biologics announced FDA's advice against expanding its VIRAGE Phase 2b study into Phase 3 for VCN-01, recommending a separate Phase 3 study with gemcitabine/nab-paclitaxel. The company also gained EU orphan drug status for VCN-01 for retinoblastoma and reported positive Phase 1 trial outcomes. Additionally, Theriva Biologics announced a 1-for-25 reverse stock split and received FDA's Rare Pediatric Drug and Fast Track Designations for VCN-01 in metastatic pancreatic adenocarcinoma.

Theriva Biologics announced FDA guidance recommending a standalone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel for metastatic pancreatic cancer, rather than expanding the ongoing VIRAGE Phase 2b study.

Theriva Biologics announces European Commission's orphan medicinal product designation for VCN-01, its oncolytic adenovirus for treating retinoblastoma, following FDA's previous orphan drug and rare pediatric disease designations. VCN-01 aims to degrade tumor stroma, enhancing chemotherapy and immunotherapy effects, with promising results from a Phase 1 trial.

Theriva Biologics announces the European Commission's adoption of the EMA's recommendation to grant orphan medicinal product designation to VCN-01 for retinoblastoma treatment, following the FDA's previous orphan drug and rare pediatric disease designations for VCN-01.

Theriva Biologics announces target enrollment in VIRAGE Phase 2b trial for VCN-01 plus standard-of-care chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC).

In July 2024, the FDA made significant strides in cancer treatment approvals and designations, including the approval of FoundationOne Liquid CDx for BRCA-mutated mCRPC and Guardant Shield for colorectal cancer detection. Fast track designations were granted to therapies like OBX-115 for melanoma and AIC100 for thyroid cancer. The FDA also accepted BLAs for treatments targeting SR-aGVHD and EBV+ PTLD, and mandated phase assessments for NSCLC perioperative regimens, aiming to improve patient outcomes.