Strasbourg,  France  –  Montreal,  Canada,  October 19th,  2022  –  Domain Therapeutics (“Domain” or “the Company”), invested and incubated by Viva BioInnovator, a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), announced that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial. The first-in-human clinical trial is on track to initiate by the end of the year.

DT-9081 is an oral small molecule drug candidate, which is able to reverse the prostaglandin E2 (PGE2)-mediated immunosuppression triggered by some tumors to bypass the immune system, by blocking the EP4 receptor present on immune cells. Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics develops an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials. Furthermore, this approach will help in finalizing the design of future clinical trials, in combination with standard of care including immune checkpoint inhibitors (such as anti-PD1).

Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: “Today’s news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic. Our proprietary assets in immuno-oncology are selected through a rigorous approach that utilizes our unrivalled expertise of GPCRs. We believe that DT-9081 has the potential to be a best-in-class therapeutic with multi-tumor applications. We look forward to dosing our first patient by the end of this year.”

Dr. Asmaa Boudribila, Medical Director at Domain Therapeutics, commented: “DT-9081 is a promising new candidate with the potential to treat a wide range of cancers. The signals and strong synergies with immune checkpoint inhibitors observed in preclinical studies strengthen our belief that DT-9081 could potentially be a game-changer in immuno-oncology therapies for cancer patients and we now look forward to progressing our first clinical milestone.”

About Domain Therapeutics

Domain Therapeutics, a biopharmaceutical company operating in France and Canada, is dedicated to the discovery and development of new drug candidates targeting G Protein-Coupled Receptors (GPCRs), one of the most important classes of drug targets. The company focuses on developing high-value drug candidates to tackle GPCR-mediated immunosuppression in immune-oncology.