Kainova Therapeutics Expands Phase I/II Trial of DT-7012, a Treg-depleting Anti-CCR8 Antibody, with First Patient Dosed in Europe
- First patient dosed in France, expanding the DOMISOL study beyond Australia
- DT‑7012 is being evaluated as monotherapy and in combination with pembrolizumab in a global clinical development program
MONTREAL and STRASBOURG, France and BOSTON, April 09, 2026 (GLOBE NEWSWIRE) -- Kainova Therapeutics (“the Company”), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced dosing of the first patient in the European expansion of its DOMISOL Phase I/II clinical trial evaluating DT‑7012, a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody, in patients with advanced solid tumors.
This dosing follows the initiation of the DOMISOL Phase I/II study in Australia, announced in October 2025, marking a significant milestone in the global clinical development of DT-7012, Kainova Therapeutics’ lead immuno-oncology program. The European expansion (NCT06819735) includes leading oncology centers in France, led by renowned early-phase clinical investigators, including Dr Lauriane Eberst at Hôpitaux Universitaires de Strasbourg, Professor Antoine Italiano at Institut Gustave Roussy in Paris, and Dr Maxime Brunet at Institut Bergonié Bordeaux.
Professor Antoine Italiano, MD PhD, Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics’ Scientific Advisory Board, 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 tumors. DT‑7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumor microenvironment.”
Dr Jean‑Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, commented: “Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship program, 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.”
The Phase I/II multicenter, open‑label DOMISOL clinical study is evaluating DT‑7012 as monotherapy in a Phase I dose-escalation, in combination with the immune checkpoint inhibitor pembrolizumab in a Phase Ib dose-escalation in patients with advanced solid tumors, and in selected tumor types in a Phase II component focused on clinical efficacy. The primary objectives include determining the maximum tolerated dose (MTD) or maximum administered dose (MAD) of DT‑7012 as monotherapy and assessing the safety and tolerability of DT‑7012 in combination with pembrolizumab.
The study also includes a translational research program with paired tumor biopsies to evaluate intratumoral Treg depletion induced by DT‑7012, providing a direct demonstration of DT-7012’s mechanism of action to turn the immunosuppressive tumor microenvironment into an immunocompetent one.
Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added: “As our flagship program, DT‑7012 is central to Kainova Therapeutics’ strategy and reflects our commitment to advancing breakthrough GPCR‑modulating therapies in immuno‑oncology and inflammation. With multiple high‑value milestones ahead, 2026 is a pivotal year for Kainova Therapeutics. We are excited to expand the DOMISOL trial into Europe and we look forward to sharing compelling data in the coming quarters.”
For more information, please contact:
Optimum Strategic Communications
Zoe Bolt, Elena Bates, Nellie Stephens
+44 (0) 203 882 9621
Kainova@optimumcomms.com
For French media:
communication@kainovatx.com
About Kainova Therapeutics
Kainova Therapeutics is a clinical-stage biopharmaceutical company, headquartered in Montreal, Canada, driving a robust pipeline of breakthrough therapies that precisely modulate G protein-coupled receptors (GPCRs) with a focus on immuno-oncology and inflammation. Kainova Therapeutics’ key programs include a unique clinical-stage Treg-depleting anti-CCR8 antibody with differentiated competitive features and a first-in-modality pre-IND stage biased negative allosteric modulator of PAR2.
By unlocking challenging and unexploited GPCR targets through its integrated discovery-to-clinic approach that integrates deep biological knowledge, Kainova Therapeutics delivers highly differentiated therapies grounded in rigorous science and designed to improve therapeutic efficacy. Recognized for a solid track record of collaborations with major pharma, physicians and KOLs worldwide, Kainova Therapeutics brings scientific excellence to the development of GPCR-modulating therapies.
Operating in North America, France, and Australia, Kainova Therapeutics applies smart trial designs, capital efficiency, and operational rigor across its programs. As GPCRs gain renewed attention as next-generation drug targets, Kainova Therapeutics is uniquely positioned to lead this evolving field. For more information, please visit https://www.kainovatx.com
About DT-7012
DT-7012 is a clinical-stage, differentiated immunotherapy candidate designed to selectively deplete highly immunosuppressive regulatory T cells (Tregs) within the tumor microenvironment (TME) by targeting CCR8 through potent ADCC and ADCP mechanisms. CCR8 has emerged as a highly compelling target in immuno‑oncology due to its predominant expression on intratumoral Tregs, and DT-7012 is designed to exploit its biology with best-in-class properties, offering a potential new treatment option for patients unresponsive to existing immunotherapies.
Distinct from other CCR8-targeting therapies in clinical development, DT-7012 binds a broader range of CCR8 receptor variants and maintains depletion efficiency even in CCL1-rich environments by preventing ligand-induced receptor internalization. This enables sustained Treg depletion in challenging TMEs and supports restoration of immune competence. DT-7012 is currently being evaluated in the global Phase I/II DOMISOL study in patients with advanced solid tumors.
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