VERAXA Biotech AG, an emerging leader in designing novel cancer therapies, announced the initiation of cell line development for its lead BiTAC® T-cell engager (BiTAC-TCE) program. VERAXA has engaged ATUM, a global leader in bioengineering and cell line development, to apply the proprietary Leap-In Transposase® technology to support stable clonal cell line generation. The collaboration marks a key step in progressing VERAXA’s most advanced T-cell engager candidate toward IND/CTA-enabling activities and supports future clinical development.
“Today’s news underscores our commitment to accelerate the development path of our growing BiTAC-TCE portfolio. Initiating cell line development with ATUM is an important next step for our lead BiTAC-TCE program following the encouraging preclinical data we presented at AACR,” said Christoph Erkel, Ph.D., Vice President Research & Development of VERAXA. “Working with a recognized cell line development partner like ATUM allows us to pair our differentiated molecular design with expertise and workflows built for exactly this kind of advanced multi-chain formats.”
Cell line development is an important milestone in translating a therapeutic candidate into a manufacturable product. The collaboration with ATUM is intended to support the generation of stable and high-producing clonal cell lines that will be used throughout CMC development, including early process, analytical, and formulation development, as well as the supply of material for nonclinical studies. ATUM’s Leap-In Transposase® technology is designed to support efficient stable cell line generation and is particularly relevant for multi-chain antibody formats where balanced expression of multiple components is important, such as VERAXA’s BiTAC-TCEs. ATUM‘s Leap-In Transposase® technology has supported the generation of stable cell lines used in over 50 IND submissions, providing VERAXA with an established cell line development approach for advanced biologic formats.
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A new generation of T-cell engagers
T-cell-engaging bispecific molecules redirect cytotoxic T-cells to eliminate cancer cells, typically by binding the CD3 receptor on T-cells while simultaneously engaging a target protein on the tumor. While effective in select indications, conventional TCEs remain limited by toxicity; because their tumor target is often also present on healthy tissue, on-target but off-tumor T-cell activation can drive serious side effects and narrow the therapeutic window. A large proportion of conventional bispecific TCEs fail in development for this reason.
VERAXA’s BiTAC-TCE approach is designed to address this challenge at its source. Rather than delivering a single, fully active molecule, the BiTAC strategy splits the T-cell engager into two complementary precursors. In their isolated form, each precursor retains its tumor-binding capability while the CD3-binding function remains inactivated. Only when both precursors bind their respective targets on the same cell is the CD3-binding domain reconstituted and activated. This “AND”-gated mechanism restricts T-cell activity to cells displaying both tumor markers, sparing healthy cells that carry only one.
A dual-target, conditional-activation design distinguishes BiTAC-TCEs from both traditional TCEs and from masked-TCE approaches that rely on a single antibody whose effector function is shielded until cleaved in the tumor microenvironment. By requiring the simultaneous engagement of two distinct antigens to assemble the active engager, BiTAC-TCEs are engineered for greater tumor selectivity, with the goal of enabling higher dosing and a meaningfully wider therapeutic window.
SOURCE: VERAXA Biotech