VERAXA Biotech (NASDAQ: VRXA) announced that 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 company also highlighted preclinical data presented at the American Association for Cancer Research Annual Meeting 2026. The data showed 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.
This regulatory feedback is significant because it validates the scientific approach of VERAXA's BiTAC platform, which aims to improve the therapeutic index of T-cell engagers by reducing off-target effects. For patients, this could mean more effective cancer treatments with fewer side effects. For the industry, it underscores the potential of conditionally active bispecific antibodies to address limitations of current immunotherapies.
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.
The full press release is available at https://ibn.fm/jpXam. For the latest news and updates relating to VRXA, visit the company’s newsroom at https://ibn.fm/VRXA.
