VERAXA Biotech Provides Overview on Implementation of FDA-Aligned Human-Relevant Models into R&D Strategy
Key Highlights
- ➤VERAXA implements FDA-aligned NAMs across all preclinical oncology programs
- ➤Ex vivo panel used about ten mice versus an estimated 200 or more
- ➤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.”
Consistent Use of New Approach Methodologies (NAMs) to Potentially Accelerate BiTAC® Oncology Pipeline and Significantly Reduce Animal Testing Needs
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.
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