VERAXA Biotech Receives Favorable Regulatory Feedback for BiTAC-TCE Cancer Therapy Platform

VERAXA Biotech announced positive regulatory feedback from Germany's Paul-Ehrlich-Institute for its BiTAC-TCE platform, providing clarity on development strategy and supporting preclinical data that showed selective targeting and improved safety profile.

Miami Metrowire Staff
Healthcare
VERAXA Biotech Receives Favorable Regulatory Feedback for BiTAC-TCE Cancer Therapy Platform

VERAXA Biotech AG (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 limitations of traditional T-cell engagers by requiring dual antigen binding for activation, potentially reducing off-target effects. VERAXA also highlighted preclinical data presented at the American Association for Cancer Research Annual Meeting 2026 showing its lead BiTAC-TCE candidate selectively targeted cancer cells expressing both intended targets while sparing cells expressing only one target. According to the company, the studies demonstrated a favorable safety profile with efficacy comparable to a traditional T-cell engager, supporting the potential for an improved therapeutic index.

VERAXA is 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. Powered by a suite of transformative technologies and guided by rigorous quality-by-design principles, the company is rapidly advancing its pipeline of ADCs and proprietary BiTAC formats into clinical development and beyond. VERAXA was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution known for pioneering life science research and cutting-edge technology.

For more information, visit the company’s newsroom at http://ibn.fm/VRXA.

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