VERAXA Biotech AG (NASDAQ: VRXA) announced the initiation of cell line development for its lead BiTAC(R) T-cell engager (BiTAC-TCE) program through a collaboration with ATUM. ATUM will apply its Leap-In Transposase(R) technology to generate stable clonal cell lines supporting IND/CTA-enabling activities and future clinical development. This collaboration follows encouraging preclinical data presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting and is intended to support CMC development, including early process, analytical and formulation development, as well as the production of material for nonclinical studies.
VERAXA said its BiTAC-TCE platform is designed to improve tumor selectivity by splitting the T-cell engager into two complementary precursors that activate only when both bind separate tumor targets on the same cell. The company believes this conditional “AND”-gated approach could reduce off-tumor toxicity associated with conventional T-cell engagers while maintaining anti-cancer activity, potentially enabling higher dosing and a broader therapeutic window. This innovation addresses a critical challenge in cancer immunotherapy: balancing efficacy with safety.
The initiation of cell line development marks a significant step toward advancing the BiTAC-TCE program into clinical trials. By partnering with ATUM, which specializes in cell line engineering, VERAXA aims to accelerate the path to investigational new drug (IND) and clinical trial application (CTA) submissions. The use of Leap-In Transposase technology is expected to enhance the speed and stability of cell line generation, which is crucial for producing consistent and high-quality material for nonclinical studies and eventual clinical use.
VERAXA’s BiTAC platform represents a novel approach to T-cell engagers, a class of immunotherapies that recruit T cells to kill cancer cells. Traditional T-cell engagers can cause significant off-tumor toxicity because they activate T cells even when only one tumor antigen is present on healthy cells. By requiring two separate tumor antigens for activation, VERAXA’s AND-gated design aims to spare healthy tissues, potentially allowing higher doses and improved patient tolerability.
The announcement underscores VERAXA’s commitment to developing next-generation antibody-based therapeutics. The company is building a pipeline of bispecific T-cell engagers, bispecific antibody-drug conjugates (ADCs), and other innovative formats. VERAXA was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution known for pioneering life science research.
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