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 company said the regulatory feedback provides greater clarity on its 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 company 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.
This regulatory milestone is significant for VERAXA as it validates the scientific foundation of its BiTAC platform and provides a clearer path to clinical trials. For investors, this reduces some uncertainty around the development timeline and regulatory acceptance of the technology. The BiTAC platform is designed to improve upon traditional T-cell engagers by requiring dual antigen binding for activation, potentially reducing off-tumor toxicity and expanding the therapeutic window.
The news comes as VERAXA continues to advance its pipeline of bispecific antibodies and antibody-drug conjugates (ADCs). The company was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution. BiTAC(R) is a registered trademark of VERAXA Biotech GmbH.
For more information, visit https://ibn.fm/jpXam.
