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, United States – Shanghai, China, March 12, 2024 – 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”.

About Domain Therapeutics

Domain Therapeutics, a clinical-stage global biopharmaceutical company, focused on developing innovative immunotherapies targeting G Protein-Coupled Receptors (GPCRs), one of the most important drug target classes, to unlock new possibilities in cancer. As a leader in GPCRs in immuno-oncology, Domain sees cancer differently, using a precise biomarker strategy to address the specific needs of patients based on unique signatures of individual cancers. Two decades of solid experience in GPCR drug discovery, validated by multiple pharma partnerships, associated to a target identification and drug discovery platform enable the Company to enhance the understanding of cancer and deliver innovative immunotherapies to patients.

Domain’s proprietary programs include DT-7012, a Treg-depleting CCR8 antibody, DT-9045, a first-in-class PAR2 negative allosteric modulator, and DT-9081, an EP4 receptor antagonist alongside the  M1069, an A2aR/A2b receptor antagonist identified in partnership with Merck KGaA. The company has also an optimized pipeline of best-in-class and first-in-class GPCR targets selected through Domain’s proprietary cross-validation drug discovery and development platform.

Domain is part of the SPRINT university hospital research project (RHU), a French consortium, led by Dr Adèle DE MASSON, directed by Paris Cité University and funded by the French government as part of the France 2030 implemented by ANR, to advance precision medicine for patients with cutaneous T-cell lymphoma.

Since 2022, the Company raised €51m ($55m) in series A  to progress preclinical and clinical development of its high-value drug candidates to address GPCR-mediated immunosuppression. Domain is supported by leading international venture capital firms from Europe (3B Future Health Fund, Seventure, Schroders, Omnes, Turenne, Theodorus), Asia (Panacea and Viva) and North America (CTI Life Science, adMare).

For more information, please visit: www.domaintherapeutics.com

About Chime Biologics

Chime Biologics is a global leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners’ success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit: www.chimebiologics.com.