VERAXA Biotech AG (NASDAQ: VRXA) announced it has received Scientific Advice from Germany's Paul-Ehrlich-Institute (PEI) 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, representing an early step in advancing the program toward clinical development.
The BiTAC-TCE platform is designed to selectively target cancer cells expressing two specific antigens while sparing healthy cells that express only one of the targets. This dual-targeting approach aims to improve the therapeutic index compared to traditional T-cell engagers, which can sometimes attack healthy tissues. VERAXA also highlighted preclinical data presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, showing that 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.
The regulatory feedback from PEI marks a significant milestone for VERAXA, as it validates the scientific rationale behind the BiTAC-TCE platform and provides a clearer path forward. The company can now refine its non-clinical development plan based on the agency's guidance, potentially accelerating the timeline to first-in-human trials. The positive preclinical data further strengthens the case for the platform's potential to offer a safer and more effective treatment option for patients with cancer.
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