VERAXA Biotech AG (NASDAQ: VRXA), a developer of next-generation antibody-based cancer therapies, has provided an update on its strategy to implement U.S. Food and Drug Administration (FDA)-aligned New Approach Methodologies (NAMs) across its preclinical research and development programs. The company said the approach could accelerate clinical advancement, reduce development costs and timelines, and significantly reduce animal testing.
VERAXA has built a panel of NAMs to characterize and de-risk its pipeline of BiTAC-based T cell engagers, antibody-drug conjugates (ADCs), and bispecific antibody-drug conjugates (bsADCs). NAMs are a set of non-animal testing methods that aim to better predict human responses and are increasingly encouraged by regulators. By integrating these methods, VERAXA aims to streamline its preclinical workflow and bring therapies to patients more efficiently.
As part of this effort, VERAXA evaluated its lead BiTAC-TCE and bsADC candidates using an ex vivo panel of 10 low-passage patient-derived xenograft models of non-small cell lung cancer. The panel required about 10 mice in total, compared with an estimated 200 or more for comparable in vivo efficacy studies. Across the panel, the combined BiTAC consistently induced potent T cell-mediated killing, supporting the company’s dual-targeting approach and demonstrating how its NAM strategy can reduce animal use and preclinical cycle time without compromising clinical relevance. This significant reduction in animal usage highlights the potential of NAMs to replace traditional animal models while maintaining rigorous scientific standards.
The implications of this announcement extend beyond VERAXA’s own pipeline. If widely adopted, NAMs could transform preclinical drug development across the biotechnology industry by lowering costs, shortening timelines, and addressing ethical concerns about animal testing. Regulatory agencies like the FDA have been encouraging the adoption of NAMs as part of a broader effort to modernize drug development. For investors, VERAXA’s progress in this area could signal a more efficient path to clinical trials and potential commercialization, enhancing the company’s value proposition. For patients, it could mean faster access to innovative cancer therapies.
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 rapidly advancing its pipeline of ADCs and proprietary BiTAC formats into clinical development and beyond. BiTAC(R) is a registered trademark of VERAXA Biotech GmbH.
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