Lonza to support manufacturing of bispecific antibody drug candidate
The therapy is being developed to redirect T-cell mediated lysis toward malignant cells expressing CLDN6.
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, said Context.
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 site in Slough in the UK, and the drug product will be manufactured at the Stein and Visp facilities in Switzerland.
Shift to more complex protein formats
Context, a clinical-stage biopharmaceutical company with headquarters in Philadelphia, which is advancing medicines for solid tumors, said it will leverage Lonza’s expertise in developing and manufacturing complex proteins, as well as its extensive regulatory competence and manufacturing network.
Bispecific antibody drug candidates targeting cancer signaling pathways pose unique challenges related to their development and manufacturing, commented Martin Lehr, CEO of Context, said: “We believe this collaboration will provide us with high-quality drug substance and drug product for clinical development and beyond.”
Jennifer Cannon, executive VP, 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.”
In terms of why the biologics pipeline been evolving towards more complex protein formats for the past few years, a spokesperson for Lonza told BioPharma-Reporter last May that monoclonal antibodies have historically been a popular therapeutic choice across many disease areas but that the entry of multichain molecules – a diverse group of proteins including bi- and multispecific non-standard antibodies – is slowly changing that.
"Due to their complex structures, multichain molecules – bi- or multispecific antibodies – have multiple sites with which to interact and bind with targets, achieving more precise binding with higher efficacy and potency than conventional antibodies.
"This increase in specificity and efficacy is especially useful in progressive cancers with high mortality rates, where multispecific molecules have enabled access to new, previously inaccessible targets.
"As a result, significant interest has been generated in these molecules, which are being referred to as the next generation of protein therapeutics. This is reflected in the 32% growth rate seen in bi-specific molecules that entered clinics from 2015 to 2020, with 161 new bi-specific clinical trials initiated in 2020 alone [as per Beacon Bispecific Database April 2021 & Bispecifics Landscape Review Jan 2021].
"For bispecific antibodies on accelerated timelines, we offer a DNA-to-IND service in only 13 months and 7 months to tox drug substance so that toxicological studies can be performed before entering GMP manufacturing. Currently, Lonza is collaborating with several companies to develop and manufacture complex bsAbs and multispecific biotherapeutics that can also target indications such as neurological disorders, targeted drug delivery or infectious diseases."