Lonza and Context Therapeutics, a US-based clinical-stage biopharmaceutical company advancing therapeutics for solid tumors, announced that they have reached a collaboration agreement 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 T&Cs of the agreement, the Swiss multinational pharma manufacturing company Lonza will provide manufacturability assessment, gene and cell line construction, and process development. The drug substance will be produced at Lonza’s Slough (UK) site, and the drug product will be manufactured at the Stein and Visp (CH) sites. Context intends to utilise Lonza’s expertise in developing and manufacturing complex proteins, as well as the extensive regulatory competence and manufacturing network.
Biopharma focuses on more complex protein formats
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.”
Martin Lehr, CEO, Context Therapeutics, 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.”
More 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 for CTIM-76 therapy.
Original Source: PHILADELPHIA and BASEL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) – https://ir.contexttherapeutics.com/news-releases/news-release-details/context-therapeutics-and-lonza-enter-manufacturing-agreement
Featured Image Credit – Copyright: Lonza Ltd.
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