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. According to the company, this approach could accelerate clinical advancement, reduce development costs and timelines, and significantly reduce animal testing.
NAMs are increasingly recognized by regulators as a way to improve the predictive validity of preclinical studies while addressing ethical concerns about animal use. VERAXA has built a panel of NAMs to characterize and de-risk its pipeline of BiTAC-based T cell engagers, antibody-drug conjugates (ADCs), and bispecific antibody-drug conjugates (bsADCs). The company said its lead BiTAC-TCE and bsADC candidates were 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—a reduction of up to 95%. 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 investors, the move signals potential cost savings and faster timelines, as preclinical development is a major expense and bottleneck in oncology drug development. By aligning with FDA initiatives, VERAXA may also position itself favorably for regulatory interactions. The company's focus on NAMs comes amid broader industry momentum toward alternative testing methods, driven by both scientific and ethical considerations.
To view the full press release, visit https://ibn.fm/9YRJw. The latest news and updates relating to VRXA are available in the company's newsroom at https://ibn.fm/VRXA. Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: https://IBN.ai/Disclaimer.
VERAXA was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution known for pioneering life science research and cutting-edge technology. BiTAC(R) is a registered trademark of VERAXA Biotech GmbH.
