VERAXA Biotech (NASDAQ: VRXA), a developer of next-generation antibody-based cancer therapies, has provided an update on its strategy to implement U.S. Food and Drug Administration-aligned New Approach Methodologies (NAMs) across its preclinical research and development programs. The company said the approach could accelerate clinical advancement, reduce development costs and timelines, and significantly reduce animal testing. This matters because it addresses a growing demand from regulators, investors, and the public for more ethical and efficient drug development, potentially setting a new standard for the industry.
VERAXA has built a panel of NAMs to characterize and de-risk its pipeline of BiTAC-based T cell engagers, antibody-drug conjugates, and bispecific antibody-drug conjugates. The company said its lead BiTAC-TCE and bsADC candidates were also evaluated using an ex vivo panel of 10 low-passage patient-derived xenograft models of non-small cell lung cancer. The panel required about 10 mice in total, compared with an estimated 200 or more for comparable in vivo efficacy studies. Across the panel, the combined BiTAC consistently induced potent T cell-mediated killing, supporting the company’s dual-targeting approach and demonstrating how its NAM strategy can reduce animal use and preclinical cycle time without compromising clinical relevance.
For leaders in biotechnology and pharmaceuticals, VERAXA’s progress signals a potential shift in how preclinical research is conducted. By reducing reliance on animal models, companies can cut costs, shorten timelines, and improve ethical standing—factors that increasingly influence partnerships, funding, and regulatory decisions. The FDA has encouraged the adoption of NAMs as part of its modernization efforts, and VERAXA’s alignment with these guidelines could position it favorably for accelerated reviews and approvals.
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