- The company has received Scientific Advice from Germany’s Paul-Ehrlich-Institute (“PEI”) supporting the proposed development strategy for its lead BiTAC(R)-TCE program.
- The regulatory feedback provides early guidance on the company’s biological rationale, safety assessments, and non-clinical development plan, for its novel therapeutic platform.
- VERAXA believes the advice helps reduce development uncertainty by providing greater clarity before advancing toward clinical studies.
- The company’s lead BiTAC(R)-TCE candidate previously generated encouraging preclinical data presented at the 2026 American Association for Cancer Research (“AACR”) Annual Meeting.
- VERAXA continues to build a diversified oncology pipeline that includes bispecific T-cell engagers, antibody-drug conjugates (“ADCs”) and other engineered antibody formats.
- The latest regulatory milestone follows continued progress in manufacturing and development as the company advances next-generation antibody therapeutics for cancer.
VERAXA Biotech (NASDAQ: VRXA), an emerging leader in designing novel cancer therapies, has taken another step in the development of its proprietary BiTAC(R)-TCE platform after receiving Scientific Advice from Germany’s Paul-Ehrlich-Institute (“PEI”), providing regulatory feedback on the biological rationale and proposed non-clinical development strategy for its lead therapeutic program. The announcement, released on July 20, signals progress as the biotechnology company prepares its most advanced BiTAC(R)-TCE candidate for future clinical development (https://ibn.fm/zBiDU).
Scientific Advice procedures allow drug developers to consult with regulatory experts before clinical trials begin, helping companies align their development strategies with regulatory expectations regarding safety, tolerability and study design.
According to VERAXA, discussions with the PEI focused on the biological mechanism underlying its dual-targeting BiTAC(R)-TCE platform together with its proposed pharmacokinetic strategy and planned non-clinical safety assessments. The company said the feedback indicated that regulators understood the scientific rationale supporting the technology and the proposed development approach. VERAXA believes this provides greater clarity regarding the path forward while reducing some of the uncertainty typically associated with advancing a novel therapeutic modality.
“Scientific Advice on the first therapeutic candidate based on a novel platform is an important early validation, and the feedback we received is encouraging,” said Christoph Erkel, Ph.D., Vice President, Research & Development of VERAXA. “It indicates that the regulatory authorities understand the biological rationale behind our BiTAC-TCE technology approach and gives us greater clarity on the development path we have proposed. For our new modality, such early alignment is crucial to make sure that we progress as efficiently as possible towards the clinics.”
VERAXA’s lead program is built around its proprietary BiTAC(R)-TCE technology, a conditionally active bispecific T-cell engager designed to recognize two target molecules before activating an immune response against cancer cells.
Traditional T-cell engagers have shown promise in oncology but may also activate immune cells against healthy tissues expressing similar targets. VERAXA’s dual-targeting approach is intended to improve selectivity by attacking cancer cells displaying both target markers while reducing activity against cells expressing only one.
The company’s most advanced BiTAC(R)-TCE candidate generated preclinical data presented during the American Association for Cancer Research (“AACR”) Annual Meeting 2026 in April. According to VERAXA, laboratory and animal studies showed the candidate behaved as intended by selectively targeting cancer cells carrying both biomarkers while sparing cells with only a single target. The company also reported that the program demonstrated efficacy comparable to a more conventional T-cell engager while producing a safety profile that could support an improved therapeutic index if confirmed in future studies.
The latest announcement also reflects continued execution of VERAXA’s broader development strategy. The company is building a diversified oncology pipeline centered on next-generation antibody therapeutics. In addition to its BiTAC(R) platform, VERAXA is developing bispecific antibody-drug conjugates (“ADCs”), additional mono- and bispecific ADC candidates, and other engineered antibody formats designed to address multiple forms of cancer.
The company traces its scientific origins to discoveries made at the European Molecular Biology Laboratory (“EMBL”), where research into antibody engineering helped establish the foundation for its current technology platforms. VERAXA has continued advancing several elements of its development program in recent months. Earlier this month, the company announced progress in cell-line development for its lead BiTAC(R)-TCE candidate, an important manufacturing step intended to support future investigational studies and eventual clinical-scale production.
Cancer immunotherapy remains one of the most active areas of drug development, with researchers seeking therapies capable of improving efficacy while reducing treatment-related toxicity. Bispecific antibodies and T-cell engagers have become an increasingly important area of research because they recruit immune cells directly to cancer cells, potentially improving treatment precision.
VERAXA’s BiTAC(R) approach seeks to build on that concept by introducing conditional activation designed to increase tumor selectivity. The company’s immediate focus remains on completing non-clinical development, validating manufacturing capabilities and preparing regulatory submissions required before clinical testing can begin.
For more information, visit the company’s website at www.Veraxa.com.
NOTE TO INVESTORS: The latest news and updates relating to VRXA are available in the company’s newsroom at https://ibn.fm/VRXA
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