Under the terms of the agreement, contract development and manufacturing organization (CDMO) Chime Biologics will ensure stable cell line development (CLD) of the antibody candidate and will provide support through clinical trials and production processes in strategic countries.
The Phase I clinical studies of DT-7012 are expected to start in early 2025 for solid tumors and mid-2025 for cutaneous T-cell lymphoma (CTCL).
“This agreement is a manufacturing agreement covering the entire process from cell line development, drug substance, drug product for the clinical batch manufacturing,” a spokesperson for Domain told BioProcess Insider.
The spokesperson confirmed that the CDMO has manufacturing facilities in Wuhan and Shanghai, China. Relying on cell line development from its Shanghai plant and IND-enabling through NDA/BLA filing at its Wuhan campus, Chime Biologics is providing pre-clinical, clinical GMP manufacturing solutions for Domain Therapeutics.
The antibody recognizes the G protein-coupled receptor (GPCR) receptor CCR8 and is expressed at the surface of Treg cells. Treg cells are regulatory T cells known to play an immunosuppressive role in shutting down the immune response in the tumor microenvironment. The antibody aims to activate antitumor immunity for cancer patients who are unresponsive to other treatments.
“This candidate is dedicated to address Treg infiltrated tumors and killing Treg using depleting functionalities on the Fc part of the antibody. Domain will pursue the development of DT-7012 in several solid tumors to be disclosed later,” the spokesperson said.
The financials of this agreement have not been disclosed.
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