Domain Therapeutics says its immuno-oncology candidate has been cleared in Belgium and France, leading to a phase I clinical trial.
It has cleared its clinical trial applications with 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.
The first-in-human clinical trial is on track to start 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 has developed a biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials. The company said 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).
Pascal Neuville, CEO of Domain Therapeutics, said: “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 unrivaled expertise of GPCRs (G Protein-Coupled Receptors). 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.”
Asmaa Boudribila, medical director at Domain Therapeutics, added: “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.”