NEWS & INSIGHTS

– Clinical trial applications accepted in France and Belgium for initiation of Phase I clinical trial
of DT-9081
– Domain’s first fully owned immuno-oncology program to enter the clinic by end of 2022
– Extensive biomarker strategy developed to optimize future clinical trials
Strasbourg, France – Montreal, Canada, October 19th, 2022 – Domain Therapeutics (“Domain” or “the
Company”), a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs)
in immuno-oncology (IO), today announces 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.”
– ENDS –
For more information, please contact:
Consilium Strategic Communications
Amber Fennell, Angela Gray, Namrata Taak
Email: DomainTherapeutics@consilium-comms.com
Tel: +44 (0)20 3709 5813