RegulatoryJul 20, 2026, 07:02 AM
Veraxa Biotech Receives Positive Regulatory Advice for BiTAC-TCE
AI Summary
Veraxa Biotech AG announced it received positive Scientific Advice from the German regulatory authority, the Paul-Ehrlich-Institute (PEI), regarding its BiTAC-TCE technology. The advice focused on the underlying biology and proposed non-clinical development plan for its most advanced program. This supportive feedback validates the biological concept and provides greater clarity, derisking the development path for the novel cancer therapy. Initial data presented at AACR 2026 demonstrated superior safety and matching efficacy for the BiTAC-TCE candidate.
Key Highlights
- Received Scientific Advice from German regulatory authority, Paul-Ehrlich-Institute (PEI).
- Advice concerns underlying biology and non-clinical development plan for BiTAC-TCE technology.
- Feedback indicates authorities understand the dual-targeting, conditionally active BiTAC-TCE format.
- Provides initial derisking of the development path and greater clarity for the program.
- Initial data from BiTAC-TCE program presented at AACR 2026 showed superior safety and matching efficacy.
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