On June 29, 2023 Domain Therapeutics ("Domain" or "the Company"), a clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), reported the nomination of a novel drug candidate, DT-7012, an anti-CCR8 monoclonal antibody depleting tumor-infiltrating regulatory T cells (Tregs), with best-in-class potential and an initial positioning that will enable fast-track development and accelerated market access (Press release, Domain Therapeutics, JUN 29, 2023, View Source [SID1234632960]).

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CCR8 is a GPCR target specifically expressed by Treg cells, one of the most important immunosuppressive immune cells responsible for the failure of several therapeutics in the clinic, including immune checkpoint inhibitors. Supported by pre-clinical data showing strong anti-tumor activity as a monotherapy, the CCR8 target is a highly strategic approach to derive efficient novel immunotherapies that aim to turn non-responder patients into responders.

Applying the Company’s precision research strategy and based on an in vitro benchmarking of competitor’s candidates, Domain has discovered a unique collection of anti-hCCR8 antibodies and nominated DT-7012 as a differentiated best-in-class Treg-depleting CCR8 antibody candidate. Unlike most competitors, DT-7012 is able to i) preserve CCR8-modulation capacity in presence of high concentrations of CCR8 in the tumor microenvironment and to ii) recognize different forms of CCR8 having different post-translational modifications. With cell line generation currently ongoing, the Company expects to start a Phase I study of DT-7012 by mid-2025.

Dr. Stephan Schann, VP Research at Domain Therapeutics, commented: "The nomination of our best-in-class Treg-depleting CCR8 monoclonal antibody candidate, DT-7012, following the recent nomination of our first-in-class PAR2 NAM candidate, DT-9045, further strengthens and continues to build Domain’s unique portfolio of GPCR-based immunotherapies. Our in vitro benchmark and comparative studies with competitor CCR8 antibodies, clearly demonstrated superiority of DT-7012 over other CCR8 clinical candidates, marking a key step in our efforts to increase the clinical success rate of treatments in non-responding patients with cancer."

The Company’s growing pipeline of GPCR-targeting immunotherapies is comprised of:

Anti-CCR8 antibody (DT-7012) – monoclonal antibody candidate
Phase I study to commence by mid-2025
PAR2 NAM antagonist (DT-9045) – small molecule candidate
Phase I study to commence by mid-2025
EP4 receptor antagonist (DT-9081) – small molecule candidate
Phase I ascending dose study dosing ongoing
A2a/A2b antagonist (M1069) – small molecule candidate in partnership with Merck KGaA
Phase I ascending dose study ongoing