- Lonza to support the development and manufacturing of CTIM-76, Context’s CLDN6 x CD3 bispecific antibody clinical candidate
- The bispecific antibody-based therapy is being developed to redirect T-cell mediated lysis toward malignant cells expressing CLDN6
Basel, Switzerland and Philadelphia, USA, 9 January 2023 – Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, and Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing medicines for solid tumors, today announced that the companies are collaborating to manufacture CTIM-76, Context’s clinical development candidate. CTIM-76 is a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody targeting CLDN6 positive tumors.
Under the terms of the agreement, Lonza will provide manufacturability assessment, gene and cell line construction, and process development. The drug substance will be manufactured at Lonza’s Slough (UK) site, and the drug product will be manufactured at the Stein and Visp (CH) sites. Context will leverage Lonza’s expertise in developing and manufacturing complex proteins, as well as the extensive regulatory competence and manufacturing network.
Martin Lehr, CEO, Context, commented: “Bispecific antibody drug candidates targeting cancer signaling pathways pose unique challenges related to their development and manufacturing. We are delighted to entrust Lonza with manufacturing Context’s clinical development candidate, CTIM-76, to target CLDN6-positive tumors. We believe this collaboration will provide us with high-quality drug substance and drug product for clinical development and beyond.”
Jennifer Cannon, Executive Vice President, Global Head of Mammalian Biologics, Lonza, added: “With the biopharmaceutical sector shifting towards more complex protein formats, it is crucial to ensure manufacturability and scalability of these novel therapies. Context has an exciting portfolio, including its CTIM-76 bispecific antibody product, that can benefit from our expertise and experience in supporting the manufacturing of complex therapeutics.”
To learn more about Lonza’s integrated drug substance and drug product DNA-to-IND program, visit https://www.lonza.com/biologics/mammalian/bispecific-antibodies-dna-to-ind-program