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, according to a press release distributed by NEWMEDIAWIRE.
NAMs are a set of methods that can replace, reduce, or refine animal testing in research. 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.
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 is important for the health industry because reducing animal testing can speed up the development of new cancer therapies while addressing ethical concerns. For patients, faster development could mean quicker access to innovative treatments. For investors, the potential for lower costs and shorter timelines could improve the financial outlook for companies like VERAXA.
VERAXA Biotech (NASDAQ: VRXA) is focused on building a premier engine for the discovery and development of next-generation 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 (EMBL). BiTAC® is a registered trademark of VERAXA Biotech GmbH.
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Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.
