ZURICH, Switzerland, July 20, 2026
VERAXA Biotech AG (NASDAQ: VRXA) announced that it has received Scientific Advice from Germany’s Paul-Ehrlich-Institute (PEI) supporting the biological rationale and proposed non-clinical development plan for its proprietary BiTAC®-TCE (Bispecific Tumor-Activated T Cell Engager) platform. The regulatory feedback provides early validation of the company’s novel therapeutic approach and offers greater clarity on the proposed development pathway as VERAXA advances its lead BiTAC-TCE product candidate toward clinical development. The Scientific Advice process allows developers to engage with regulatory experts on key aspects of drug safety, tolerability, pharmacokinetics, and non-clinical evaluation, helping reduce development risks before entering human studies. The positive response represents an important milestone for VERAXA as it continues developing next-generation antibody-based cancer therapies designed to improve treatment precision and safety.
PEI Feedback Supports BiTAC-TCE Development Strategy
During the Scientific Advice meeting, VERAXA presented the biological mechanism behind its dual-targeting, conditionally active BiTAC-TCE technology, along with its proposed strategy for safety assessments, pharmacokinetics, and non-clinical development. According to the company, the Paul-Ehrlich-Institute acknowledged the scientific rationale underlying the platform and provided supportive regulatory feedback that helps de-risk the overall development program. Early regulatory alignment is particularly valuable for innovative therapeutic modalities because it provides developers with greater confidence in study design, regulatory expectations, and future clinical planning. VERAXA noted that this guidance will help streamline development while ensuring that the program progresses efficiently toward first-in-human clinical studies.
Preclinical Data Demonstrate Targeted Activity and Improved Safety Profile
VERAXA previously presented preclinical data from its lead BiTAC-TCE program at the American Association for Cancer Research (AACR) Annual Meeting 2026. The studies demonstrated that the investigational therapy selectively attacked cancer cells expressing both target antigens while sparing healthy cells that expressed only one target, illustrating the precision of its conditionally activated dual-targeting mechanism. Both in vitro and in vivo findings showed that the BiTAC-TCE candidate achieved comparable anti-tumor efficacy to conventional T-cell engagers (TCEs) while exhibiting a superior safety profile, suggesting the potential for a significantly improved therapeutic index. These encouraging results support the platform’s goal of reducing off-target toxicity while maintaining potent anti-cancer activity, addressing one of the major limitations associated with traditional T-cell engager therapies.
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VERAXA Expands Next-Generation Antibody-Based Oncology Pipeline
The positive regulatory feedback further strengthens VERAXA Biotech’s strategy to build a diversified portfolio of next-generation antibody therapeutics targeting cancer. The company’s pipeline includes bispecific T-cell engagers (TCEs), bispecific antibody-drug conjugates (ADCs), and proprietary BiTAC therapeutic formats, all developed using technology originating from the European Molecular Biology Laboratory (EMBL). By combining innovative molecular engineering with quality-by-design development principles, VERAXA aims to advance safer and more effective targeted cancer therapies into clinical development. The latest Scientific Advice from the Paul-Ehrlich-Institute provides an important regulatory foundation for the BiTAC-TCE platform and positions the company to accelerate the transition of its lead oncology candidate toward future clinical evaluation.
Source: VERAXA Biotech press release
