VERAXA Biotech (NASDAQ: VRXA) has 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. This 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. The feedback represents an early step in advancing the program toward clinical development.
VERAXA 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.
The BiTAC-TCE platform is designed to address limitations of conventional T-cell engagers by incorporating conditional activation and dual targeting, which may reduce off-tumor toxicity and improve the therapeutic window. The regulatory feedback from the Paul-Ehrlich-Institute is a key milestone for VERAXA as it progresses its pipeline toward clinical trials.
For more details on the press release, visit https://ibn.fm/jpXam. Additional information about VERAXA Biotech and its latest news can be found in the company's newsroom at https://ibn.fm/VRXA.
VERAXA Biotech AG 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 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).
This development underscores the potential of VERAXA's BiTAC-TCE platform to offer a new approach in cancer immunotherapy, with the regulatory feedback providing validation of the non-clinical development strategy. The company's ability to advance this program could have significant implications for patients with cancers that are difficult to treat with existing therapies.
