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Context Therapeutics and Lonza Enter Manufacturing Agreement for Bispecific Antibody Targeting Claudin 6-Positive CancersLonza 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 PHILADELPHIA and BASEL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing medicines for solid tumors, and Lonza, a global development and manufacturing partner to the pharma, biotech, and nutrition industries, 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.” About Claudin 6 and CTIM-76 Claudin 6 (CLDN6) is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others. With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an important drug target. CTIM-76 is a CLDN6 and CD3 bispecific antibody currently in preclinical development that is capable of binding to tumor cells expressing CLDN6 and stimulating intra-tumoral T cells by the CD3 arm that is designed to be activated only upon tumor engagement while silent elsewhere. CLDN6 is expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer, and gastric cancer. Preclinical studies of CTIM-76 show it effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN6 antibody and CD3 antibody while avoiding systemic immunotoxicity commonly seen with CD3 antibodies as a drug class. CTIM-76 has the potential for convenient dosing and scalable manufacturing to address the significant number of patients who are potentially eligible fo CTIM-76 therapy. About Context Therapeutics® For more information, please visit www.contexttherapeutics.com or follow the Company on Twitter and LinkedIn. About Lonza Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With more than 17,000 full-time employees, we comprise high-performing teams and individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 3 billion with a CORE EBITDA of CHF 987 million in H1 2022. Find out more at www.lonza.com. Follow @Lonza on LinkedIn Context Therapeutics Contact Details Media Contact: Investor Relations Contact: Lonza Contact Details Forward-looking Statements |