Chime Biologics to Manufacture Novel Antibody Cancer Immunotherapy for Domain Therapeutics

Editor's note: this story was originally published on www.BioPharmInternational.com.

Domain Therapeutics (Domain), a clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology that target G protein-coupled receptors (GPCRs), entered into a manufacturing agreement with Chime Biologics, a contract development and manufacturing organization. Chime Biologics will produce Domain’s regulatory T cell (Treg)-depleting anti-CCR8 antibody candidate, DT-7012, Domain announced in a March 12, 2024 press release.

Under the agreement, Chime Biologics will ensure stable cell line development (CLD) and manufacturing services for the candidate to support clinical trials in strategic countries. Chime Biologics operates a global modular facility that employs single-use bioprocessing technology. According to the company, this facility meets international current good manufacturing practice standards and holds proven audit track records.

The candidate, DT-7012, is a novel anti-CCR8 comprising monoclonal antibody (mAb)-depleting tumor-infiltrating Tregs, which are major immunosuppressive cells. The company stated, in the press release, that, “Treg depletion with anti-CCR8 mAb has demonstrated a unique anti-tumor potency as a monotherapy” and noted that, “DT-7012 has a proven best-in-class potential compared to other clinical-stage CCR8 antibodies, paving the way for effective GPCR-targeting immunotherapies, aiming to activate antitumor immunity for cancer patients unresponsive to other treatments”.

The company expects to start Phase I clinical studies of the candidate in early 2025 for solid tumors. In mid-2025, it expects to start Phase I clinical studies in cutaneous T-cell lymphoma.

Domain nominated DT-7012 in June 2023 (1). The company choose this candidate because of its unique ability and potential as a monotherapy to cure cancer in preclinical studies. The company expects the candidate to achieve a position that will enable its fast-track development and accelerated market access. According to the company, DT-7012 is able to preserve CCR8-modulation capacity in the presence of high concentrations of CCR8 in the tumor microenvironment. It also has the ability to recognize different forms of CCR8 that have different post-translational modifications (1).

“We look forward to progressing this strategic partnership, which combines Domain’s leading anti-CCR8 antibody candidate with Chime Biologics’ CLD-to-commercial manufacturing expertise, contributing to the development of DT-7012 for various cancers,” said Jimmy Wei, president of Chime Biologics, in a company press release.

“We’re thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage. This new GPCR-targeting immunotherapy has immense potential to unlock the immune system’s cancer fighting abilities and help patients globally. At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology,” said Stephan Schann, chief scientific officer of Domain Therapeutics, in the release.

In addition to DT-7012, Domain’s pipeline of GPCR-targeting immunotherapies also includes:

• PAR2 NAM antagonist (DT-9045): a small-molecule candidate expected to begin a Phase I study by mid-2025
• EP4 receptor antagonist (DT-9081): a small-molecule candidate expected in an ongoing Phase I ascending dose study
• A2a/A2b antagonist (M1069): a small-molecule candidate being developed in partnership with Merck KGaA that is in an ongoing Phase I ascending dose study.

Reference

1. Domain Therapeutics. Domain Therapeutics Announces Nomination of Best-in-class CCR8 Antibody Candidate, DT-7012, Further Strengthening Its Unique Portfolio of GPCR-targeting Immunotherapies. Press Release, June 29, 2023.

Source: Domain Therapeutics