SOTIO Biotech has dosed the first subject in its Phase I clinical trial VICTORIA-01 to assess the novel immunocytokine SOT201 to potentially treat patients with advanced solid tumours.

The dose escalation, open-label, first-in-human trial will evaluate the tolerability, safety, and preliminary efficacy of SOT201 as a single agent to treat advanced solid tumours. 

Subjects aged 18 years or above with advanced unresectable or metastatic solid tumours are eligible for the trial.

The University of Texas MD Anderson Cancer Center in Houston, Texas, US, is currently enrolling participants.

Additional trial sites in European countries, including Belgium, the Czech Republic, and Spain, are set to begin enrolment shortly.

SOT201, a PD-1-targeting immunocytokine, could enhance the efficacy of already approved checkpoint inhibitors.

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The preclinical data for SOT201 indicated a potential for robust anti-tumour activity and wide clinical applicability.

SOTIO Biotech chief medical officer Richard Sachse said: “While anti-PD-1 therapeutics have been a great advance in cancer medicine, still only a minority of patients respond to them. Additionally, even patients successfully treated frequently acquire resistance to these therapies, leading to cancer progression. Novel treatments are needed to overcome these therapeutic limitations.

“The initiation of the VICTORIA-01 study demonstrates SOTIO’s continued dedication to delivering innovative immunotherapies that can address the challenges of solid tumour treatment. We look forward to further researching the potential that SOT201 holds for patients who have not seen success with other available treatments.” 

Last October, SOTIO entered a licence and option deal with Synaffix, a Lonza company, for developing antibody-drug conjugates (ADCs) to treat solid tumours.

Synaffix’s ADC technology platform is being used for developing up to three novel ADCs targeting distinct tumour-associated antigens.