VERAXA Biotech AG (NASDAQ: VRXA) has announced receipt of 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 the dual-targeting, conditionally active BiTAC-TCE platform, marking an early step in advancing the program toward clinical development.
The company also highlighted preclinical data presented at the American Association for Cancer Research 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 Biotech 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 details, the full press release is available at https://ibn.fm/jpXam. Investors can access the latest news and updates relating to VRXA in the company's newsroom at http://ibn.fm/VRXA.
This regulatory milestone is significant for VERAXA as it validates the scientific foundation of its BiTAC-TCE platform and provides a clear pathway toward clinical trials. The positive feedback from PEI, a key European regulatory body, could accelerate the development timeline and enhance the company's position in the competitive cancer immunotherapy landscape. The preclinical data showing selective tumor targeting and a favorable safety profile further strengthen the case for BiTAC-TCE as a potential best-in-class therapy.
