Kainova's Novel Cancer Drug Trial Expands, Targeting Tumor Defenses

MONTREAL, QC – April 09, 2026 – Kainova Therapeutics has dosed the first European patient in a pivotal clinical trial for its lead immuno-oncology candidate, DT-7012, marking a significant expansion in the global effort to develop a new class of cancer treatments. The move brings a promising new therapeutic strategy to patients with advanced solid tumors and signals a major step forward for the Canadian biopharmaceutical company.

The European arm of the DOMISOL Phase I/II study was initiated in France, building on the trial's initial launch in Australia in October 2025. This expansion into a second continent accelerates the clinical development of DT-7012, a proprietary monoclonal antibody designed to overcome one of cancer's most effective defense mechanisms.

A New Front in the War on Cancer

The DOMISOL trial (NCT06819735) is a multicenter, open-label study evaluating DT-7012 in patients whose advanced solid tumors have progressed after standard therapies. Its multi-pronged design is structured to gather comprehensive data quickly and efficiently. The Phase I portion will determine the optimal dose of DT-7012 when administered as a monotherapy, while a Phase Ib component will assess its safety and tolerability when used in combination with the widely used immune checkpoint inhibitor pembrolizumab.

Following the initial dose-finding stages, a Phase II component will focus on clinical efficacy in specific hard-to-treat cancers, including non-small cell lung cancer, triple-negative breast cancer, and ovarian cancer, among others. The European expansion involves some of the continent's most prestigious oncology centers, including the Institut Gustave Roussy in Paris, Hôpitaux Universitaires de Strasbourg, and Institut Bergonié in Bordeaux, engaging a team of renowned clinical investigators.

“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,” said Professor Antoine Italiano, MD PhD, Head of Precision Medicine at Institut Gustave Roussy and a member of Kainova's Scientific Advisory Board. “DT‑7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumor microenvironment.”

Disarming the Tumor's Bodyguards

At the heart of Kainova's strategy is a sophisticated approach to immuno-oncology that goes beyond current treatments. Many cancers thrive by creating a highly immunosuppressive bubble around themselves, known as the tumor microenvironment (TME). A key component of this defense system is a population of cells called regulatory T cells, or Tregs. These cells act as bodyguards for the tumor, suppressing the patient's natural immune response and rendering many therapies ineffective.

DT-7012 is engineered to selectively eliminate these traitorous Tregs by targeting a protein called CCR8, which is predominantly found on the surface of the most immunosuppressive Tregs within the tumor. By binding to CCR8, the antibody flags these cells for destruction, effectively disarming the tumor's defenses and allowing the patient's immune system to recognize and attack the cancer.

While other companies are exploring the CCR8 pathway, Kainova asserts that DT-7012 possesses distinct advantages. Preclinical data suggests the antibody binds to a broader range of CCR8 variants and, crucially, maintains its Treg-depleting power even in environments rich in CCL1—a ligand that can cause other antibodies to be internalized by the cell, rendering them useless. This feature is designed to ensure sustained Treg depletion in challenging tumors.

To prove this mechanism works in humans, the DOMISOL trial incorporates a robust translational research program. Investigators will analyze paired tumor biopsies taken before and after treatment to directly measure the reduction in intratumoral Tregs, providing a clear demonstration of DT-7012's ability to remodel the TME from an immunosuppressive to an immunocompetent state.

Dr. Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, commented on the trial's design, stating, “The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT-7012 across both monotherapy and combination settings... These data will be essential to inform dose selection and support the next phases of development.”

Global Ambition Fueled by Strategic Growth

The European expansion is not just a scientific milestone but a clear indicator of Kainova's strategic ambitions. The company, formerly known as Domain Therapeutics, is positioning itself as a leader in modulating G protein-coupled receptors (GPCRs), a class of proteins like CCR8 that are critical for cell communication and are gaining renewed attention as next-generation drug targets.

This clinical momentum is supported by strong financial backing. In February 2026, Kainova announced the successful first close of a $32 million CAD Series B financing round led by Investissement Québec. This infusion of capital is intended to drive the clinical advancement of its pipeline, with DT-7012 as the flagship program.

“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,” said Sean A. MacDonald, the company's Chief Executive Officer. “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.”

With operations in Canada, France, and Australia, Kainova is leveraging a global footprint to execute its clinical trials with capital efficiency and operational rigor. The involvement of top-tier European institutions and investigators further solidifies the program's credibility and potential for global impact. As the field of immuno-oncology continues to evolve, Kainova's precise, science-driven approach to targeting GPCRs places it in a strong position to lead a new wave of innovation. As the DOMISOL study progresses on three continents, the oncology community will be watching closely for the initial data that could validate this promising new strategy in the fight against cancer.