VERAXA Biotech Provides Overview on Implementation of FDA-Aligned Human-Relevant Models into R&D Strategy
Key Highlights
- ➤VERAXA (VRXA) implements FDA-aligned NAMs across all preclinical programs
- ➤Ex vivo panel used about ten mice versus 200 or more for comparable studies
- ➤Lead BiTAC-TCE showed superior safety and matched efficacy versus traditional TCE
- ➤New spheroid data validated T cell engagement specificity for IND-enabling studies
Expert Statements
Christoph Erkel, Chief Scientific Officer of VERAXA
“We see NAMs as not just a regulatory obligation, but also as a scientific opportunity”
Christoph Erkel, Chief Scientific Officer of VERAXA
“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.”
Christoph Erkel, Chief Scientific Officer of VERAXA
“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.”
ZURICH, SWITZERLAND, Oct. 07, 2026 (GLOBE NEWSWIRE) -- VERAXA Biotech AG (NASDAQ: VRXA; “VERAXA” or the “Company”), a leading developer of next-generation antibody-based cancer therapies, today provided an update on its strategy and progress to implement a suite of U.S. Food and Drug Administration (FDA) aligned New Approach Methodologies (NAMs) across its preclinical research and development programs, potentially enabling faster clinical advancement while significantly reducing animal testing. This strategic implementation positions VERAXA 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 for developing safe and effective therapies.
NAMs encompass a range of technologies, including cell-based assays, organ-on-chip systems, computational modeling and ex vivo tissue models, designed to more accurately predict human biological responses while reducing dependence on animal models. Beyond this regulatory alignment, the shift toward more sustainable and ethical research practices is also expected to reduce development costs and timelines, for example, by bypassing certain non-human primate (NHP) toxicology studies traditionally required ahead of clinical development.
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