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, marking a key milestone in advancing the platform toward clinical development.
The 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. This represents an early step in moving the program from preclinical research into human trials.
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 BiTAC-TCE platform is designed to address a critical limitation of conventional T-cell engagers: off-target toxicity. By requiring dual antigen binding for activation, the therapy aims to selectively kill cancer cells while minimizing damage to healthy tissue. The regulatory feedback from the Paul-Ehrlich-Institute, Germany’s federal authority responsible for vaccines and biomedicines, validates the scientific approach and provides a clearer regulatory pathway.
“This Scientific Advice is an important step in the development of our BiTAC-TCE program,” the company stated, emphasizing that the feedback confirms the agency’s understanding of the platform’s biology and non-clinical development plan. The clarity on regulatory expectations reduces uncertainty and allows VERAXA to refine its preclinical studies ahead of an eventual Investigational New Drug (IND) application.
The news is significant for VERAXA as it seeks to differentiate its pipeline in the competitive bispecific antibody space. The company’s broader strategy includes bispecific T-cell engagers, bispecific antibody-drug conjugates (ADCs), and other innovative formats. Founded on scientific breakthroughs at the European Molecular Biology Laboratory (EMBL), VERAXA aims to apply quality-by-design principles to rapidly advance its proprietary BiTAC formats and ADCs into clinical development.
For more details, the full press release is available at https://ibn.fm/jpXam. Updates on VERAXA can be found in the company’s newsroom at https://ibn.fm/VRXA.
Forward-looking statements in this article involve risks and uncertainties as detailed in the company’s filings with the SEC. Undue reliance should not be placed on these statements, which are based on information available as of the date hereof. All parties undertake no duty to update this information unless required by law.
