December 2, 2020 -- Tubulis and WuXi Biologics have announced a strategic collaboration to manufacture Tubulis' next-generation antibody-drug conjugates (ADCs) toward investigational new drug (IND)-enabling studies.
Tubulis has developed a dual platform to generate uniquely matched and disease-specific ADCs that combine selective antibodies and effective payloads. Tubulis recently completed a $12.95 million series A financing round to expand the therapeutic potential of ADCs and to advance its uniquely versatile and customizable ADC technology portfolio. The company's platform includes cysteine-selective conjugation technology and human-derived Tub-tag technology to modify antibodies.
The partnership will support the scale-up of the manufacturing process for clinical development. The first program that the companies will collaborate on is TUB-010, a protein-drug conjugate designed to treat patients with lymphoma.
Under the agreement, WuXi Biologics and WuXi STA Pharmaceutical will become the contract development and manufacturing organization (CDMO) partners for Tubulis. They will perform scale-up, process development, and good manufacturing practice (GMP) manufacturing for the ADC product intermediates. STA will be focused on linker and payload and WuXi Biologics on the monoclonal antibodies and enzymes used in the technology.
WuXi Biologics will then conduct process development and GMP bioconjugation to produce the drug substance along with final drug product formulation and fill/finish services for preclinical toxicology studies. WuXi Biologics will also supply product batches for clinical evaluation.