On October 7, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA" or the "Company"), a leading developer of next-generation antibody-based cancer therapies, reported 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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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.
"We see NAMs as not just a regulatory obligation, but also as a scientific opportunity," said Christoph Erkel, Ph.D., 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. 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."
VERAXA has been building a multi-layered panel of NAMs to characterize and de-risk its pipeline of BiTAC (bi-targeted tumor-associated cytotoxicity) based T cell engagers (BiTAC-TCEs), BiTAC-based antibody drug conjugates (BiTAC-ADCs) and bispecific antibody-drug conjugates (bsADCs) technologies. At the AACR (Free AACR Whitepaper) Annual Meeting 2026, the Company presented initial data on its most advanced BiTAC-TCE program. In those studies, the candidate performed as intended in vitro and in vivo, attacking cancer cells that displayed both target molecules while sparing cells expressing only one of the two, with a safety profile that was superior, and efficacy that matched, a more traditional TCE, pointing to the possibility of a meaningfully improved therapeutic index. The in vitro results came from three-dimensional, cell line-derived spheroid models, which recapitulate solid tumor architecture more closely than two-dimensional culture. VERAXA has since generated new spheroid data demonstrating consistent predictivity of T cell engagement specificity across diverse cancer cell lines and validating the model for IND-enabling studies, further reinforcing this model’s translational value ahead of clinical development.
VERAXA further evaluated its lead BiTAC-TCE and bsADC candidates in an ex vivo panel of ten low-passage patient-derived xenograft models of non-small cell lung cancer, models that closely preserve the molecular characteristics, heterogeneity, and therapeutic response of the original tumors. Because these assays draw on tumor material from a small number of donor mice and can be split into many parallel patient samples, the panel required only about ten mice in total, versus an estimated 200 or more for comparable in vivo efficacy studies.
Across the panel, the combined BiTAC consistently induced potent T cell-mediated killing, while relevant controls, including commercial T cell engagers against non-expressed targets, showed only minimal activity, providing strong evidence that VERAXA’s dual-targeting approach extends beyond cell line models into clinically meaningful anti-tumor activity, validating the need for simultaneous dual-target engagement and reinforcing BiTAC as a next-generation approach to T cell redirection. This ex vivo platform demonstrates how VERAXA’s NAM strategy reduces both animal use and preclinical cycle time without compromising clinical relevance.
(Press release, Veraxa Biotech, OCT 7, 2026, View Source [SID1234673278])