On December 2, 2020 Tubulis, WuXi STA and WuXi Biologics reported a strategic collaboration to manufacture and advance Tubulis’ next generation antibody-drug conjugates (ADCs) towards IND-enabling studies (Press release, Tubulis, DEC 2, 2020, View Source [SID1234572079]). Tubulis has developed a dual platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads. This approach has demonstrated superior stability and efficacy in preclinical studies. The partnership with WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms and STA Pharmaceutical, a WuXi AppTec Company, (WuXi STA), will support the scale-up of the manufacturing process to a global clinical standard. The first program from Tubulis’ pipeline the companies will collaborate on is TUB-010, a uniquely matched, highly stable and efficient protein-drug conjugate designed to treat patients with lymphoma.

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Under the terms of the agreement, WuXi Biologics and WuXi STA will become the Contract Development and Manufacturing Organization (CDMO) partners for Tubulis. WuXi Biologics and WuXi STA will perform scale-up, process development and GMP manufacturing for the ADC product intermediates, with WuXi STA focused on the linker and payload and WuXi Biologics on the monoclonal antibody (mAb) and the enzyme used in Tubulis´ proprietary Tub-tag technology. WuXi Biologics subsequently will conduct process development and GMP bioconjugation to produce the drug substance and the final drug product formulation and fill for final preclinical toxicology studies. WuXi Biologics will also supply product batches for clinical evaluation. Financial details of the collaboration were not disclosed.

"As leaders in manufacturing for innovative technology platforms, WuXi Biologics and WuXi STA provide world-class capabilities for the development and production of our ADCs," said Dr. Dominik Schumacher, CEO of Tubulis. "For our uniquely versatile and customizable ADC technology portfolio, it was important to partner with CDMOs that have extensive experience with ADCs and offer the opportunity for a long-term partnership at the highest quality level. We are rapidly moving towards the clinic with our first ADC candidate and are excited to have entered this partnership, which will enable the further maturation of our pipeline."

"Tubulis requires single-source technology platforms, scientific expertise and state-of-the-art facilities set to the highest global quality standards. This is why we are thrilled to be selected for this project," remarked Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration is a perfect illustration of the value that WuXi Biologics provides to innovative companies worldwide. Bioconjugates like TUB-010 are highly complex and require high levels of expertise and integration across the entire supply chain. We will leverage our advanced development platforms, large scientific teams dedicated to ADCs and industry-leading development timelines to bring TUB-010 towards the clinic."

"We are honored that Tubulis selected our organization to help bring this novel therapeutic towards the clinic with the goal of benefiting patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA. "I am confident that WuXi STA’s leading capability and capacity for high potency API, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. Our strong connection and past experience working with WuXi Biologics on ADC therapeutics, and our shared commitment to providing seamless project management and one-stop services, will ensure that together we can develop and manufacture TUB-010 efficiently."

Tubulis recently completed a €10.7 million Series A to expand the therapeutic potential of ADCs and to advance its uniquely versatile and customizable ADC technology portfolio. The company utilizes two proprietary technologies to tackle limitations of currently approved ADCs, which include stability and payload-driven toxicity. With the P5 conjugation, Tubulis employs a cysteine-selective conjugation that enables the generation of ultra-stable ADCs with unprecedented linker stability and chemical flexibility, enabling rapid lead identification. The second technology, the human-derived Tub-tag platform, modulates the antibody to provide a highly beneficial microenvironment for the payload, thereby adding a significant amount of stability to the ADC. By tailoring the ADCs to the respective indication, Tubulis develops innovative compounds to treat cancer and beyond.