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 company stated that the regulatory feedback provides greater clarity on its 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 selectively target cancer cells expressing both intended targets while sparing cells expressing only one target. VERAXA highlighted preclinical data presented at the American Association for Cancer Research Annual Meeting 2026, which demonstrated a favorable safety profile with efficacy comparable to a traditional T-cell engager, supporting the potential for an improved therapeutic index. According to the company, these studies suggest that the BiTAC-TCE candidate could offer a better balance between efficacy and safety compared to existing T-cell engagers.
The regulatory feedback from the Paul-Ehrlich-Institute is a significant milestone for VERAXA, as it validates the company's scientific approach and provides a clearer path forward for the development of its lead candidate. The company believes that this guidance will help streamline the non-clinical development process and potentially accelerate the timeline to first-in-human studies.
VERAXA Biotech is focused on building a premier engine for the discovery and development of next-generation antibody-based therapeutics, including bispecific T cell engagers, bispecific ADCs, and other innovative formats. The company was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution known for pioneering life science research. BiTAC(R) is a registered trademark of VERAXA Biotech GmbH.
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