ZURICH, Switzerland — October 7, 2026
VERAXA Biotech AG provided an update on its strategy to implement FDA-aligned New Approach Methodologies (NAMs) across its preclinical research and development programs. The company is integrating a range of human-relevant, non-animal and non-clinical testing approaches with the goal of potentially accelerating clinical development while significantly reducing reliance on animal testing. VERAXA said its strategy is aligned with the FDA’s evolving roadmap encouraging the phased reduction and eventual replacement of animal testing where scientifically appropriate. The company is applying NAMs across its pipeline of BiTAC® oncology technologies, including bi-targeted tumor-associated cytotoxicity T-cell engagers (BiTAC-TCEs), BiTAC-based antibody-drug conjugates (BiTAC-ADCs) and bispecific antibody-drug conjugates (bsADCs). The approach is intended to generate more human-relevant data earlier in development and potentially reduce preclinical timelines and costs.
Human-Relevant Models Support BiTAC-TCE Development
VERAXA has established a multi-layered panel of NAMs to characterize and de-risk its next-generation antibody-based cancer therapies. These methodologies include cell-based assays, three-dimensional spheroid models, organ-on-chip systems, computational modeling and ex vivo tissue models designed to better reflect human biology than conventional testing approaches. At the AACR Annual Meeting 2026, VERAXA presented initial data from its lead BiTAC-TCE program showing that the candidate selectively attacked cancer cells expressing both target molecules while sparing cells expressing only one target. The company reported that the candidate demonstrated a safety profile superior to a more traditional T-cell engager while maintaining comparable efficacy in the reported studies. VERAXA has subsequently generated additional data using three-dimensional, cell line-derived spheroids, demonstrating consistent prediction of T-cell engagement specificity across diverse cancer cell lines and supporting the model’s potential use in IND-enabling development.
Ex Vivo Models Reduce Animal Testing Requirements
VERAXA has also evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo panel of 10 low-passage patient-derived xenograft models of non-small cell lung cancer (NSCLC). These models are designed to preserve key molecular characteristics, tumor heterogeneity and treatment responses from the original tumors. According to the company, the ex vivo approach required approximately 10 mice in total, compared with an estimated 200 or more animals that could be required for comparable in vivo efficacy studies. Across the panel, the combined BiTAC approach produced potent T-cell-mediated cancer cell killing, while relevant control T-cell engagers directed against non-expressed targets demonstrated minimal activity. VERAXA said these findings provide evidence that its dual-targeting strategy can maintain activity beyond cell-line models and support the potential clinical relevance of simultaneous engagement of two tumor-associated targets. The company views the ex vivo platform as an important component of its effort to reduce animal use while maintaining translational value.
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VERAXA Targets Faster Preclinical-to-Clinical Progress
The implementation of FDA-aligned NAMs is becoming a central component of VERAXA’s development strategy as the company advances its BiTAC technology portfolio toward clinical development. By combining human-relevant models with computational and experimental approaches, VERAXA aims to identify potential safety and efficacy risks earlier while generating data that may better predict human responses. The company also expects the approach to reduce dependence on certain traditional studies, including selected non-human primate toxicology testing, where scientifically and regulatorily appropriate. VERAXA said its NAM strategy is intended not only to support regulatory alignment but also to improve research efficiency and sustainability. With its lead BiTAC programs continuing to generate preclinical evidence across increasingly complex models, VERAXA is positioning human-relevant testing as a core element of its next-generation oncology development platform, potentially enabling faster progression of its T-cell engager and antibody-drug conjugate candidates toward clinical evaluation while reducing the need for extensive animal studies.
Source::VERAXA Biotech, press release
