Domain Therapeutics and Chime Biologics announce manufacturing agreement to advance novel anti-CCR8 antibody for cancer immunotherapy

• The agreement combines Domain Therapeutics' candidate DT-7012 with Chime Biologics' internationally-recognized manufacturing expertise 
• In June 2023, Domain nominated DT-7012, a Treg depleting anti-CCR8 monoclonal antibody (mAb) with best-in-class potential, which enters Phase I studies in 2025
• The CCR8 GPCR target is a highly strategic approach in immuno-oncology to increase clinical success rates in non-responding patients

STRASBOURG, France, BOSTON and SHANGHAI, March 12, 2024 /PRNewswire/ -- Domain Therapeutics ("Domain"), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), and Chime Biologics, a leading Contract Development and Manufacturing Organization (CDMO) that enables its partners' success in biologics, today announce the signing of a manufacturing service agreement for the production of Domain's best-in-class Treg depleting anti-CCR8 antibody candidate, DT-7012. This phase of manufacturing aims to deliver an effective therapeutic for cancer patients worldwide.

Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries. Chime Biologics' first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.

DT-7012 is a novel anti-CCR8 mAb depleting tumor-infiltrating Tregs, major immunosuppressive cells. Treg depletion with anti-CCR8 mAb has demonstrated a unique anti-tumor potency as a monotherapy. 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 anti-tumor immunity for cancer patients unresponsive to other treatments. 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).

Dr. Jimmy Wei, President of Chime Biologics, commented: "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".

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "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".