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 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 interaction is a significant milestone for VERAXA as it seeks to advance its BiTAC-TCE platform, which is designed to conditionally activate T cells only in the presence of two specific tumor antigens, potentially reducing off-target effects common with traditional bispecific T cell engagers. The company believes this approach could lead to a better therapeutic index, meaning higher efficacy with fewer side effects.
VERAXA is building a pipeline of next-generation antibody-based therapeutics, including bispecific T cell engagers, bispecific ADCs, and other innovative formats. The company was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL). The BiTAC(R) trademark is a registered trademark of VERAXA Biotech GmbH.
For more information, visit the company’s newsroom at https://ibn.fm/VRXA. The full press release is available at https://ibn.fm/jpXam.
