VERAXA Biotech Receives Regulatory Feedback for BiTAC-TCE Cancer Therapy Platform, Paving Way for Clinical Development

VERAXA Biotech (NASDAQ: VRXA) announced it has received Scientific Advice from Germany's Paul-Ehrlich-Institute regarding the underlying biology and proposed non-clinical development plan for its lead proprietary BiTAC-TCE cancer therapy program. The regulatory feedback provides greater clarity on the company's proposed development strategy and indicates that the agency understands the biological rationale behind its dual-targeting, conditionally active BiTAC-TCE platform. This represents an early step in advancing the program toward clinical development.

The BiTAC-TCE platform is designed to address a key limitation of traditional T-cell engagers: off-tumor toxicity. By requiring the simultaneous presence of two tumor-associated antigens for activation, the therapy aims to spare healthy cells that express only one target. VERAXA highlighted preclinical data presented at the American Association for Cancer Research Annual Meeting 2026 showing that its lead candidate selectively targeted cancer cells expressing both intended targets while sparing cells expressing only one target. The studies demonstrated a favorable safety profile with efficacy comparable to a traditional T-cell engager, supporting the potential for an improved therapeutic index.

This regulatory milestone is significant for VERAXA as it validates the scientific foundation of its platform and provides a clearer path to clinical trials. The company, founded on scientific breakthroughs at the European Molecular Biology Laboratory (EMBL), is building a pipeline of next-generation antibody-based therapeutics, including bispecific T cell engagers and bispecific ADCs. The BiTAC technology is a registered trademark of VERAXA Biotech GmbH.

For more information on the full press release, visit https://ibn.fm/jpXam. The latest news and updates relating to VRXA are available in the company's newsroom at https://ibn.fm/VRXA.