VERAXA Biotech (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 significant because it validates the scientific approach underlying VERAXA's BiTAC platform, which aims to address key limitations of traditional T-cell engagers, such as off-target toxicity. By requiring dual antigen recognition for activation, the BiTAC-TCE platform is designed to selectively engage cancer cells while minimizing damage to healthy tissue. This could lead to a higher therapeutic index, potentially enabling more effective dosing and broader applicability across multiple cancer types.
The positive preclinical data and regulatory guidance position VERAXA to move closer to initiating clinical trials. The company's ability to demonstrate a favorable safety profile in preclinical models is crucial for advancing to first-in-human studies. If successful, the BiTAC-TCE platform could offer a new treatment option for patients with cancers that have limited therapeutic choices.
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 company 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.
For more details, the full press release is available at https://ibn.fm/jpXam. The latest news and updates relating to VRXA are available in the company’s newsroom at https://ibn.fm/VRXA.
