- VERAXA is implementing FDA-aligned New Approach Methodologies (“NAMs”) across its preclinical research programs, aiming to improve the relevance of experimental findings to human biology while reducing animal testing.
- The strategy supports development of the company’s BiTAC(R) T-cell engagers, BiTAC-based antibody-drug conjugates and bispecific antibody-drug conjugates for the treatment of cancer.
- New three-dimensional spheroid data reportedly reinforce the ability of VERAXA’s models to assess the dual-target specificity of its lead T-cell engager candidates.
- An ex vivo study involving 10 low-passage patient-derived xenograft models of non-small cell lung cancer required about 10 mice, compared with an estimated 200 or more for comparable in vivo efficacy studies.
- The company says its lead BiTAC candidate induced potent T-cell-mediated tumor-cell killing across the tested models, while relevant controls showed minimal activity.
VERAXA Biotech (NASDAQ: VRXA), an emerging leader in designing novel cancer therapies, is expanding its use of human-relevant testing methods across its oncology research programs, seeking to generate more clinically informative preclinical data while reducing the number of animals required for drug development.
In an October 7, 2026, company announcement, the Switzerland-based biotechnology company, with a key financial and regulatory presence in the U.S., outlined its implementation of New Approach Methodologies (“NAMs”), a collection of non-animal research techniques that includes cell-based assays, computational modeling and tissue models (https://nnw.fm/LvwrI). VERAXA said the strategy aligns with the U.S. Food and Drug Administration’s 2025 roadmap encouraging a phased reduction in animal testing in favor of alternative methods.
The initiative is particularly relevant to VERAXA’s BiTAC(R) platform, which is designed to direct immune-cell activity toward cancer cells displaying two selected targets. The company is applying its testing framework to programs involving BiTAC-based T-cell engagers (“TCEs”), antibody-drug conjugates (“ADCs”) and bispecific ADCs.
VERAXA reported that its most advanced BiTAC-TCE program produced initial results presented at the American Association for Cancer Research Annual Meeting in 2026. According to the company, the candidate performed as intended in laboratory and animal studies, attacking cancer cells expressing both selected target molecules while sparing cells expressing only one.
The company said the candidate demonstrated a safety profile superior to that of a more conventional T-cell engager, while matching its efficacy in the reported studies. If confirmed through further research, that combination could support a more favorable therapeutic index: the relationship between a treatment’s desired effects and its harmful effects.
Conventional T-cell engagers can activate immune cells against tumors but may also affect healthy cells that express a target shared with cancer. VERAXA’s dual-targeting design seeks to make cytotoxic activity conditional on the simultaneous presence of both targets on the same tumor cell. To assess that selectivity, the company has used three-dimensional spheroid models derived from cancer cell lines. Unlike conventional two-dimensional cell cultures, spheroids more closely reproduce aspects of solid-tumor architecture. VERAXA said subsequent experiments across diverse cancer cell lines produced consistent results for T-cell engagement specificity.
The company considers the data supportive of using the spheroid model in investigational new drug (“IND”)-enabling studies, the preclinical work that helps determine whether a drug candidate is ready to be evaluated in humans.
VERAXA also evaluated its lead BiTAC-TCE and bispecific ADC candidates using an ex vivo panel of 10 low-passage patient-derived xenograft models of non-small cell lung cancer. These models use tumor material that preserves important molecular characteristics and heterogeneity of the original tumors. By dividing available tissue into multiple parallel samples, researchers can examine treatment responses across experimental conditions without conducting a separate animal study for every comparison.
According to VERAXA, the panel required approximately 10 mice in total, compared with an estimated 200 or more for comparable in vivo efficacy studies. The company said the combined BiTAC approach consistently induced potent T-cell-mediated killing across the panel, while relevant controls, including commercial T-cell engagers directed at targets not expressed in the tested models, showed minimal activity.
The findings provide additional preclinical support for the company’s central hypothesis: requiring two target molecules may help direct immune activity more selectively toward cancer cells. The ex vivo work illustrates how alternative testing methods may reduce animal use while preserving information about tumor biology. Whether the approach can reliably shorten development timelines or reduce overall costs will depend on how the models perform in subsequent studies and how regulators assess the resulting evidence.
The FDA’s evolving position on NAMs has increased the relevance of alternative preclinical methods for biotechnology companies. Such approaches can include organ-on-chip systems, computational tools and human tissue-based assays intended to provide information that conventional animal models may not fully capture.
VERAXA Chief Scientific Officer Christoph Erkel said the company views these methods as both a scientific opportunity and a way to make research practices more sustainable. “We’ve been investing in translational, human-relevant model systems well ahead of the FDA’s 2025 roadmap, and we see this shift as beneficial and a win-win situation for both science and sustainability. Reducing our reliance on animal studies, particularly NHP toxicology testing, allows us to generate more clinically predictive data, move faster, and do so more efficiently and sustainably,” Erkel said.
For more information, visit the company’s website at www.Veraxa.com.
NOTE TO INVESTORS: The latest news and updates relating to VRXA are available in the company’s newsroom at https://nnw.fm/VRXA
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