At a glance
- Company
- VERAXA Biotech AG
- Ticker
- NASDAQ: VRXA
- Announcement
- Regulatory
Key figures
- Patient-derived non-small cell lung cancer models in panel
- 10
- Mice used for the ex vivo panel
- about 10
- Estimated mice for comparable in vivo efficacy studies
- 200 or more
Products and programs
VERAXA Biotech (NASDAQ: VRXA), a developer of next-generation antibody-based cancer therapies, provided an update on its strategy to implement U.S. Food and Drug Administration “FDA”-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.
VERAXA 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.
To view the full press release, visit https://ibn.fm/9YRJw
About VERAXA Biotech AG
At VERAXA, we are 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. Powered by a suite of transformative technologies and guided by rigorous quality-by-design principles, we are rapidly advancing our pipeline of ADCs and proprietary BiTAC formats into clinical development and beyond. 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.
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In brief
VERAXA Biotech reported progress in adopting New Approach Methodologies (NAMs) aligned with U.S. Food and Drug Administration guidance across its preclinical research. The company says its methods are intended to help assess and reduce risk in programs involving BiTAC-based T cell engagers and antibody-drug conjugates, while potentially lowering animal use, costs and development time. VERAXA also described testing lead BiTAC-TCE and bispecific ADC candidates in an ex vivo panel of patient-derived non-small cell lung cancer models. According to the company, the panel used about 10 mice overall, versus an estimated 200 or more for comparable in vivo efficacy studies. VERAXA said the combined BiTAC produced T cell-mediated killing across the models, which it views as support for its dual-targeting approach and NAM strategy.
Key takeaways
- VERAXA says it is applying FDA-aligned NAMs across preclinical research and development.
- Its ex vivo panel covered 10 patient-derived non-small cell lung cancer models.
- The panel used about 10 mice, compared with an estimated 200 or more for comparable in vivo studies.
- The company reported T cell-mediated killing across the model panel with its combined BiTAC.
SEC filings
Earlier from VERAXA Biotech AG
- VERAXA Biotech (NASDAQ: VRXA) Advances Oncology Pipeline as Xlife Sciences Reports First-Half Progress
- VERAXA Biotech (NASDAQ: VRXA) Builds Oncology Pipeline Around BiTAC Platform, Public-Market Story Enters Next Phase
- VERAXA Biotech (NASDAQ: VRXA) Adds Capital Markets Veteran as CFO While Advancing BiTAC Oncology Pipeline
- VERAXA Biotech (NASDAQ: VRXA) Building a New Approach to Precision Cancer Therapy
- VERAXA Biotech (NASDAQ: VRXA) Appoints Raju Willener as Chief Financial Officer
