VERAXA Biotech Advances FDA-Aligned New Approach Methodologies to Reduce Animal Testing in Preclinical Research

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.

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. This matters because the biopharmaceutical industry faces increasing pressure to improve the predictiveness of preclinical models while reducing reliance on animal testing. The FDA has been encouraging the adoption of NAMs as part of its modernization efforts, and companies that successfully integrate these methods could gain a regulatory and ethical advantage.

For VERAXA, the update signals that its NAM strategy is not merely a compliance exercise but a core component of its development engine. By using patient-derived xenograft models and other ex vivo assays, the company aims to generate human-relevant data earlier, potentially reducing the risk of late-stage clinical failures. The reduction in animal use—from an estimated 200 mice to about 10—also addresses growing investor and public concern about animal welfare in research.

The announcement comes as VERAXA continues to advance its pipeline of antibody-based therapeutics, including bispecific T cell engagers, bispecific ADCs, and other innovative formats. The company was founded on scientific breakthroughs made at the European Molecular Biology Laboratory, a world-renowned institution known for pioneering life science research. Its BiTAC® format is a registered trademark of VERAXA Biotech GmbH.

Investors and industry observers may view the NAM update as a sign that VERAXA is positioning itself at the forefront of a broader shift in preclinical testing. If the company’s NAMs prove as predictive as traditional animal models, they could help shorten development timelines and lower costs, making it a more attractive partner for larger pharmaceutical companies. The approach also aligns with the FDA’s stated goal of reducing animal testing while maintaining rigorous safety and efficacy standards.

For more details, the full press release is available at https://ibn.fm/9YRJw. The latest news and updates relating to VRXA are available in the company’s newsroom at https://ibn.fm/VRXA. Additional information about VERAXA Biotech (NASDAQ: VRXA) can be found at VERAXA Biotech (NASDAQ: VRXA).

As the industry awaits further data from VERAXA’s NAM panel, the company’s progress will be closely watched as a test case for whether FDA-aligned alternatives can truly deliver on the promise of faster, cheaper, and more ethical drug development.