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.
VERAXA 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.
The regulatory feedback from the Paul-Ehrlich-Institute is a significant milestone for VERAXA as it de-risks the non-clinical development pathway and aligns the company with regulatory expectations early in the process. This guidance helps VERAXA refine its preclinical studies to meet the requirements for initiating clinical trials. The BiTAC-TCE platform is designed to overcome limitations of conventional T-cell engagers by requiring dual antigen binding for activation, which may reduce off-tumor toxicity and improve safety.
VERAXA is building a pipeline of next-generation antibody-based therapeutics, including bispecific T cell engagers, bispecific ADCs and other innovative formats. The company’s BiTAC technology originated from scientific breakthroughs at the European Molecular Biology Laboratory (EMBL). For more information, visit the company’s newsroom at http://ibn.fm/VRXA.
The receipt of Scientific Advice marks an early but crucial step in translating the BiTAC-TCE platform from preclinical research to clinical application. With the regulatory feedback in hand, VERAXA can proceed with confidence in its non-clinical development plan, aiming to bring a potentially safer and more effective T-cell engaging therapy to cancer patients.
