Clinical TrialMay 7, 2026, 08:15 AM
Theriva Biologics gets FDA agreement for VCN-01 Phase 3 PDAC trial
AI Summary
Theriva Biologics announced FDA agreement on the Phase 3 trial design for VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC), aligning with EMA's scientific opinion. Additional Phase 2b data for VCN-01 in PDAC showed improved patient outcomes and a potential immune-mediated mechanism. The company also reported Q1 2026 financial results, including a reduced net loss of $2.0 million and $14.4 million in cash, providing liquidity until Q1 2027. Discussions are ongoing for a Phase 2/3 trial of VCN-01 for retinoblastoma, with compassionate use data expected.
Key Highlights
- FDA agreed on Phase 3 trial design for VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC).
- Phase 2b VCN-01 data showed improved overall survival in PDAC patients, including those with liver metastases.
- Q1 2026 net loss decreased to $(2.0) million from $(4.3) million in Q1 2025.
- Cash and cash equivalents were $14.4 million as of March 31, 2026.
- Research and development expenses decreased 88% to $355,000 in Q1 2026.
- General and administrative expenses increased 43% to $2.1 million in Q1 2026.
- Liquidity is expected to fund operations until Q1 2027.
- Phase 2/3 trial for VCN-01 in retinoblastoma is planned, with first patient by December 2026.
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