On March 31, 2025 UZ Leuven and VIB-KU Leuven, in collaboration with Seattle-based Presage Biosciences, reported the first patient treated in a Non-randomized (phase I – pharmacodynamic only) open label, single center single arm interventional pilot study (Press release, Presage Biosciences, MAR 31, 2025, View Source [SID1234651696]). By combining intratumoral treatment with systemic anti-PD1 therapy in first line patients with metastatic (stage IV) or inoperable stage III melanoma, the trial studies how patient tumors respond to up to 7 different drugs simultaneously dosed intratumorally with the help of Presage’s Comparative In Vivo Oncology (CIVO) microinjection device.

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The drugs are spatially microdosed in a patient’s tumor while they are also undergoing anti-PD1 systemic therapy with the goal of identifying drugs that have an enhanced combination effect in this patient population. The localized effect of the different drugs is analyzed with cutting edge single cell spatial technology providing new insights into melanoma biology and the anti-tumor action of the CIVO dosed drugs when combined with systemic anti-PD1 therapy.

Prof. Dr. Oliver Bechter, Medical Oncologist at UZ Leuven, comments on this innovative study design: "This is the first study of its kind studying locally administered anti-cancer drugs in combination with systemic anti-PD1 therapy in first line treated melanoma patients. With this pilot study we intend to study the effect of novel combination therapies intratumorally very early in the treatment course of melanoma patients. This pilot study will show the feasibility of such an approach to find new treatments especially for anti-PD1 refractory patients."

Prof. Dr. Chris Marine, Cancer Biologist of the VIB-KU Leuven Center for Cancer Biology added: "The introduction of this groundbreaking technology has ushered us into a new frontier in translational research, enabling us to translate our most promising laboratory discoveries directly into patients. By utilizing our expertise in advanced spatial multi-omics, we will gain an unparalleled understanding of each tumor’s biology and its sensitivity to various drug combinations. The unique data generated from this will be invaluable in accelerating our efforts to combat this disease."

This first of its kind study is made possible by the multiplex CIVO delivery technology developed by Presage that is now being used in early phase clinical studies to evaluate multiple investigational new drugs and combinations all within a single intact patient tumor. Jason Frazier, VP of Technology and Research Operations at Presage echoed the enthusiasm for this novel clinical study design: "Drs. Bechter and Marine and their teams at UZ Leuven and VIB-KU Leuven have come up with an exciting and innovative clinical study design to assess tumor response to multiple different drugs in combination with Check Point blockade using our CIVO technology. This personalized approach to identify effective combination therapies holds great promise for the treatment of melanoma patients."