VERAXA Biotech Advances Cancer Therapy Research with Human-Relevant Models

ZURICH, SWITZERLAND, Oct. 07, 2026 /CourierPR/ -- VERAXA Biotech AG, a leading developer of next-generation antibody-based cancer therapies, has announced significant progress in implementing a suite of U.S. Food and Drug Administration (FDA)-aligned New Approach Methodologies (NAMs) into its preclinical research and development programs. This strategic move positions the company ahead of the FDA’s 2025 roadmap, which encourages the phased reduction and ultimate replacement of animal testing in favor of human-relevant, non-animal, and non-clinical test methods.

According to Christoph Erkel, Ph.D., Chief Scientific Officer of VERAXA, the company has been investing in translational, human-relevant model systems well ahead of the FDA’s timeline.

At the AACR Annual Meeting 2026, VERAXA presented initial data on its most advanced BiTAC-TCE program. The candidate performed as intended in vitro and in vivo, attacking cancer cells that displayed both target molecules while sparing cells expressing only one of the two, with a safety profile that was superior and efficacy that matched a more traditional TCE. The in vitro results came from three-dimensional, cell line-derived spheroid models, which more closely recapitulate solid tumor architecture than two-dimensional culture.

VERAXA has since generated new spheroid data demonstrating consistent predictivity of T cell engagement specificity across diverse cancer cell lines and validating the model for IND-enabling studies. This further reinforces the model’s translational value ahead of clinical development. The company has also evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo panel of ten low-passage patient-derived xenograft models of non-small cell lung cancer. These models closely preserve the molecular characteristics, heterogeneity, and therapeutic response of the original tumors.

Because these assays draw on tumor material from a small number of donor mice and can be split into many parallel patient samples, the panel required only about ten mice in total, versus an estimated 200 or more for comparable in vivo efficacy studies. Across the panel, the combined BiTAC consistently induced potent T cell-mediated killing, while relevant controls, including commercial T cell engagers against non-expressed targets, showed only minimal activity. This provided strong evidence that VERAXA’s dual-targeting approach extends beyond cell line models into clinically meaningful anti-tumor activity, validating the need for simultaneous dual-target engagement and reinforcing BiTAC as a next-generation approach to T cell redirection.

The company’s implementation of NAMs is expected to reduce development costs and timelines, for example, by bypassing certain non-human primate (NHP) toxicology studies traditionally required ahead of clinical development. Beyond regulatory alignment, the shift toward more sustainable and ethical research practices is also anticipated to reduce animal testing, thereby enabling faster clinical advancement.

VERAXA Biotech AG is building a premier engine for the discovery and development of next-generation antibody-based cancer therapeutics, powered by a suite of transformative technologies and guided by rigorous quality-by-design principles. The company is rapidly advancing its pipeline of conditionally active T cell engagers (BiTAC-TCEs), bispecific antibody-drug conjugates (bsADCs), and proprietary BiTAC formats into clinical development. Uniquely, VERAXA has implemented FDA-aligned New Approach Methodologies across all preclinical programs, enabling faster clinical advancement while reducing reliance on animal testing.

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