Kainova Therapeutics has dosed the first patient in the European expansion of its DOMISOL phase 1/2 trial of DT 7012, a Treg-depleting anti-CCR8 antibody, marking a key step in the company’s global development strategy.

The study, which began in Australia in October 2025, is now enrolling patients at leading oncology centres in France, including Hôpitaux Universitaires de Strasbourg, Institut Gustave Roussy in Paris and Institut Bergonié Bordeaux.

The programme is being led by early-phase investigators Dr Lauriane Eberst, Professor Antoine Italiano and Dr Maxime Brunet.

Professor Antoine Italiano, Head of Precision Medicine at Institut Gustave Roussy, said: “This study brings together strong clinical expertise and advanced translational capabilities, creating an important opportunity to explore how targeted Treg depletion may translate into meaningful benefit for patients with advanced solid tumours. DT 7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumour microenvironment.”

Dr Jean Marie Cuillerot, Chief Medical Officer at Kainova Therapeutics, explained: “Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship programme, DT 7012.

“The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT 7012 across both monotherapy and combination settings, including paired biopsies to directly assess the intra-tumoral Treg depletion. These data will be essential to inform dose selection and support the next phases of development.”

Amgen has announced positive topline findings from a phase 3 study evaluating a subcutaneous formulation of Tepezza in adults with moderate-to-severe active thyroid eye disease (TED).

The company said the on-body injector version delivered efficacy comparable to the intravenous formulation, which is currently the only approved treatment for the condition.

The phase 3 trial met its primary endpoint, with a statistically significant and clinically meaningful proptosis response rate of 76.7 percent at week 24 compared with 19.6 percent for placebo. Mean proptosis reduction reached 3.17 mm, exceeding the threshold regarded as clinically meaningful.

Jay Bradner, executive vice president of Research and Development at Amgen, said: “These results extend and support the best-in-class efficacy of TEPEZZA for people living with thyroid eye disease, now with subcutaneous administration delivering IV-level efficacy.”

He added: “With a well-understood mechanism and established impact in the clinic, we can evolve how the medicine is delivered to potentially reach even more patients through a more convenient subcutaneous option.”

The study also demonstrated statistically significant improvements across several secondary endpoints, including overall responder rate, Clinical Activity Score of 0 or 1, diplopia measures and the Graves’ Ophthalmopathy Quality of Life appearance subscale. A numerical trend favouring Tepezza was observed in the visual functioning subscale, although this did not reach statistical significance.